Single-implant overdentures retained by the Novaloc attachment system: study protocol for a mixed-methods randomized cross-over trial

Background Overdentures retained by a single implant in the midline have arisen as a minimal implant treatment for edentulous mandibles. The success of this treatment depends on the performance of a single stud attachment that is susceptible to wear-related retention loss. Recently developed biomaterials used in attachments may result in better performance of the overdentures, offering minimal retention loss and greater patient satisfaction. These biomaterials include resistant polymeric matrixes and amorphous diamond-like carbon applied on metallic components. The objective of this explanatory mixed-methods study is to compare Novaloc, a novel attachment system with such characteristics, to a traditional alternative for single implants in the mandible of edentate elderly patients. Methods/design We will carry out a randomized cross-over clinical trial comparing Novaloc attachments to Locators for single-implant mandibular overdentures in edentate elderly individuals. Participants will be followed for three months with each attachment type; patient-based, clinical, and economic outcomes will be gathered. A sample of 26 participants is estimated to be required to detect clinically relevant differences in terms of the primary outcome (patient ratings of general satisfaction). Participants will choose which attachment they wish to keep, then be interviewed about their experiences and preferences with a single implant prosthesis and with the two attachments. Data from the quantitative and qualitative assessments will be integrated through a mixed-methods explanatory strategy. A last quantitative assessment will take place after 12 months with the preferred attachment; this latter assessment will enable measurement of the attachments’ long-term wear and maintenance requirements. Discussion Our results will lead to evidence-based recommendations regarding these systems, guiding providers and patients when making decisions on which attachment systems and implant numbers will be most appropriate for individual cases. The recommendation of a specific attachment for elderly edentulous patients may combine positive outcomes from patient perspectives with low cost, good maintenance, and minimal invasiveness. Trial registration ClinicalTrials.gov, NCT03126942. Registered on 13 April 2017. Electronic supplementary material The online version of this article (10.1186/s13063-018-2606-7) contains supplementary material, which is available to authorized users.


Purpose of this Consent Form
We are inviting you to participate in a research study designed to assess the success of a special type of treatment using dental implants, and to compare two types of connectors used to attach your lower denture to these implants. The results of the research will provide further knowledge about how to treat elderly patients who lose teeth. This consent form aims to: a. inform you, as completely as possible, of the nature, purpose and risks involved in the study; b. provide you with the necessary information you may need to decide if you will participate or not, according to your personal goals; c. help us talk with you about your disability and its treatment.
Please read this consent form carefully and ask any questions that you may have before deciding whether or not to participate in this study. The researchers are here to help you understand completely, so please feel free to ask about anything you may want to know about the study. Please take as much time as you wish and feel free to discuss this study with your family or friends before deciding. Your participation is entirely voluntary, and if you decide not to participate, there will be no penalties or loss of benefits to which you are entitled.
If you prefer conventional dentures or are fully satisfied with your present dentures, you should NOT consider participating in this study. Page 2 of 9

Introduction
For many years, dentists have provided complete dentures for people with no teeth, but dentures only stay in the mouth by holding onto the gums and bone. Many denture wearers are able to wear an upper denture without difficulties, but have difficulties wearing their lower dentures because of looseness and discomfort. Without teeth, jawbones shrink, causing further loosening of dentures, making it hard for people to chew and speak with ease.
Studies have shown that people who wear lower dentures are significantly more satisfied with them when dental implants support them. Dental implants can make a lower denture more stable and improve chewing and comfort. Implants are shaped like dental roots, inserted in the jawbone, and dentures snap onto them.
Elderly patients are most likely to have no teeth and little remaining bone; a lack of a strong bone foundation makes it difficult to securely place implants. In addition, the cost of implant treatment is usually far beyond the means of most elderly people. Therefore, using a minimum number of implants, such as a single implant in the front part of the lower jaw where enough bone is most likely to remain, will also lower the cost. The denture can be attached to the implant using a connector that holds the denture tight.
Many dentists have considered two implants as the minimum number to securely hold a lower denture in place. We believed that a single implant could not last in the mouth for long or hold the denture strongly enough. However, recent studies show that a single implant can stay in place for the same time as with more than one implant. The satisfaction of patients with their lower dentures is similar after receiving one or two implants.
We will compare a new type of connector to another often used around the world; both are attached with a single implant in the lower jaw. Participants using these will rate their satisfaction with both types and describe their experiences with each connector in individual interviews. The costs for each type will also be recorded to determine the cost-benefit associated with each connector. The results of this study will guide dentists and patients when choosing the most appropriate connector for their needs.

Objectives
The primary goal of this study is: Page 3 of 9 -To learn about your satisfaction with a new connector type called Novaloc, which is attached to a single implant in your lower jaw, compared to a traditional type called Locator. We also wish to know which would be your preferred connector and some reasons as to why you may prefer this connector. We plan to ask you why you prefer one of these connectors in an interview.
Our secondary goals involve comparing these connectors according to: -How they affect quality of your life and questions about how well the connectors and dentures work; -how well your dentures will work with each connector from the dentist's viewpoint, including the need for repairs and survival of all denture parts and implants; -estimated cost of the treatment.

Study Procedures
Our goal is to include 26 participants in this study. You may be eligible to participate in this study if you: -Are 65 years or older and have no natural teeth for at least 6 months; -Have a complete set of dentures in good condition, and would like the lower denture to be supported by an implant; -Have enough bone in the top part of your lower jaw; -Are in relatively good health and able to clean your dentures. Please tell us if you have any disease or are taking medicines (including those for thinning your blood or for weak bones).
If you are interested in participating, we will do some exams and fill out forms similarly to what is done in routine dental treatment with implants. This will include asking questions about your general and oral health, an examination of your mouth and x-rays of your jawbone. The results of these exams will be compared to a list of characteristics our study needs from participants to confirm if you are eligible to participate.
After this first appointment, you will be told whether you can participate. If you are interested in participating, we will need you to sign this consent form. You can take the consent form home to discuss with family, dentist, denturist or others, if you wish. After you sign the consent form, we will collect some of the information described in the objectives, and schedule another appointment for installing the implant. Page 4 of 9 When you come for the 2 nd appointment, you will receive the implant (3.3 mm wide and at least 10 mm long). First, we will numb your lower jaw to prevent pain. Then, we will prepare the jawbone and install the implant. We will place some stiches and then the denture will be trimmed above the implant and stiches. Then, we will wait for the jawbone to heal for eight weeks or more. In the meantime, we will schedule at least one visit to see if the healing is going well, after approximately one week.
After a healing period of eight weeks, we will install components that will stabilize your lower denture.
We will screw a cylindrical metal part into your new implant, whereas the lower denture will receive another part containing a plastic capsule. The plastic capsule snaps into the metal cylinder and provides extra stability. Each connector type (Novaloc or Locator) is composed of a different cylinder shape and material, and has a specific capsule, with different shape and type of plastic. You will be given one of the two connectors based on selection by a random (by chance) selection (we will count the beginning of the study time from this moment). We will make a small hollow in your lower denture that will serve to accommodate the component and bind it to the denture, using an acrylic material.
Three months after you receive the first connector type, we will schedule an appointment to collect all the information listed in the objectives (questionnaires answered by an examining dentist and you), except for the interview about your preferences. You will then receive another type of attachment (if you start with Locator, you will receive Novaloc now, and vice-versa). We will remove the old component from the denture by gently grinding away the acrylic around it.
Three months later (total time: 6 months), we will collect the same information gathered during the previous appointment. We may keep the same component type or place the previous one back, as you prefer. After this, another researcher will interview you outside of the clinic (estimated time: 1 hour) and ask about your preferences and experiences with the components and the treatment you received as a whole.
One year later (total time: 18 months), we will collect information in the clinic using the same questionnaires done for the three-month appointment.
We may also take pictures of your dentures and mouth and keep used component pieces for study material.
The table below shows the stages of the study. Some minor appointments (removing stiches, taking x-rays and some eventual adjustment of your dentures) will also be necessary. If you leave this study before or at the end, you will be referred to a dentist of your choice for occasional check-ups and regular or emergency dental care. Any unplanned change to received treatment will likely lead to your exit from the study; unplanned changes include: new dentures, changing components or more implants (please bring these changes to our attention, if they happen).

Associated risks and inconveniences
The risks associated with treatment are the same expected for minor oral surgery and dental prosthetics.
Prior to implant placement, you will receive an anesthetic injection to reduce sensitivity to pain. An allergic reaction to the injection is rare, although possible. If this occurs, safe, standard procedures will be followed. These could include providing anti-histamines and / or adrenaline.
You may experience some sore spots under your dentures after the placement of implants or retentive components. If this happens, the dentures will be adjusted for you as necessary. Allergic reactions to dental materials (such as the acrylic mixture used to bond components and denture) are rare but might also occur.
You may experience a change in, or loss of, feeling in your lips, gums, and/or chin after implant placement. This is usually temporary. Some soreness may occur in the gums where the implants are placed, but this discomfort should be minimal and disappear within a few days. An over-the-counter medication (e.g.: aspirin, Tylenol) should control that pain. No risks or complications are expected from the x-rays.
Your lower denture might break after the installing retentive components inside it. If this happens during the study timeline, we will fix/repair it at no cost.
Losing an implant is uncommon but possible. If your implant is lost or does not attach to the bone, it will be replaced. If it happens, you might opt to return to a conventional denture; we will do it for you if Page 6 of 9 needed. Implants can become loose, causing the gums to become sore or infected. If this occurs, the implant will be removed and, if necessary, an antibiotic can be taken for the infection.
If you have questions/concerns about anything that does not feel/look right, please contact us as soon as possible.

Benefits
You may or may not benefit personally from taking part in this project. One expected benefit is better stability/tightness in the fit of your lower denture. It is possible that you will be able to chew better and have a more comfortable lower denture fit. All treatment involved in this study (implant, adapting your denture and changing components during the 18-month period) will be done free of charge. You will benefit from having a dentist examine the health of your mouth, including your gums and tongue. This study will provide researchers with new information about the use of new dental treatment methods and materials for the elderly, and the results of this study may help develop better and more affordable treatments for lost teeth.
You must expect, however, that dentures will not completely eliminate all impairments caused by teeth loss and that results will vary between participants.

Financial Compensation
As compensation for travel expenses to/from the clinic for the 3 data collection appointments (visits 4, 5 and 6 in the Table), you will receive $25 at each visit, for a total of $75 for 3 visits.

Protection of confidentiality:
During your participation in this project, the research team will gather information about you in some forms required to meet the project's scientific goals.
All data relating to your participation in this study will be kept strictly confidential and will be protected with a code. The key code connecting your name to your research file will be kept by the researcher responsible. Research data will be kept in the office of Dr. de Souza, principal investigator for McGill University. The data will be kept secured for 25 years after the end of the study and will then be destroyed.
Similarly, a code will also be assigned to your sample material (such as implant connectors) that will link it to your name. To ensure the confidentiality of this code and to prevent revealing your name or identity,

Communication of results
Once the study is completed, we plan to inform the study participants and the general public of the results of the study, in order to improve the treatment of teeth loss in the elderly. Thus, a summary of the study results will be shared with you via email if you wish, or conventional mail if you do not use or do not have access to email or internet. The results will also be available to you and to the general public through social media and the web, with focus on dental professionals.
The results of this research will be presented at scientific meetings and published in scientific journals.
No study participant names or identifiable information will be disclosed through these methods.
Photographs of your mouth and dentures could be presented for scientific purposes, but they will not show your identity.

Voluntary participation and right of withdrawal
Your participation is voluntary and, by signing this consent form, you are not waiving any of your rights.
In addition, by signing the form, you are not releasing the researchers from their legal and professional responsibilities and liability.
You may leave or withdraw from this study at any time, without giving any reason. You simply have to notify the contact person in the research team, and this can be done verbally or in writing. In case of withdrawal, the information that had been collected up until the time of your withdrawal will not be destroyed so as not to jeopardize the integrity of the study. Throughout the study, you will be notified of any new information that might make you reconsider your participation in the study. Your participation, refusal to participate or withdrawal from the study will have no impact on the care that you receive at the dental clinics of the McGill University. Page 9 of 9 CONSENT FORM: The research project described in this consent form has been explained to me. I am aware of the purpose of this study, aware of what I am being asked to do, and the risks and benefits of taking part in the study.
All questions I had about this study have been answered, and I can get more information at any time during the study. I am aware that I can withdraw from this study at any time. I consent and agree to take part in this study. I do not give up any of my legal rights by signing this consent form. I will receive a copy of this consent form for my records.

INTRODUCTION
We are inviting you to take part in this research study because you have no natural teeth and currently wear full dentures. Also, you wish to hold your lower denture better on the jaw by using implants. Regular dentures tend to be less stable for the lower jaw; many people have difficulties wearing their lower dentures because of looseness and discomfort. You should be 65 years or older, because most people with full dentures are seniors. Plus, seniors tend to: (1) have smaller lower jawbones that give weak support to a regular denture; (2) prefer a small number of implants (as we will use), just to hold a denture better. Other reasons are: your health, lower jawbone size and oral hygiene allow us to place a dental implant.
However, before you accept to take part in this study and sign this information and consent form, please take the time to read, understand and carefully examine the following information. You may also want to discuss this study with your family doctor, a family member or a close friend.
This form may contain words that you do not understand. We invite you to speak to the researcher responsible for this study (the "study doctor") or to other members of the research team, and ask them to explain to you any word or information that is unclear to you before you sign this form.

BACKGROUND
For many years, dentists have provided full dentures for people with no teeth. However, dentures only stay in the mouth by holding onto the gums and bone. Many denture wearers can wear an upper denture easily, but have difficulties wearing their lower dentures because of looseness and discomfort. Without teeth, jawbones shrink, causing further loosening of dentures. This makes it hard for people to chew and speak.
Studies have shown that people who wear lower dentures are more satisfied with them when dental implants support them. Dental implants can make a lower denture more stable and improve chewing and comfort. Implants are shaped like dental roots, inserted in the jawbone, and dentures snap onto them. The technical name of this type of denture is "overdenture".
Elderly patients are most likely to have no teeth and little remaining bone; a lack of a strong bone foundation makes it difficult to securely place implants. In addition, the cost of implant treatment is usually far beyond the means of most elderly people. Therefore, using a minimum number of implants, such as a single implant in the front part of the lower jaw where enough bone is most likely to remain, will also lower the cost. The denture can be attached to the implant using a connector that holds the denture tight. Recent studies show that a single implant can stay in place for the same time as with more than one implant.
We will compare a new type of connector to another often used around the world; both are attached with a single implant in the lower jaw. We will invite you to rate your satisfaction with both connectors and describe your experiences with each connector in individual interviews. We will calculate the costs for each type determine their cost-benefit. Our results will guide dentists and patients when choosing the most appropriate connector for their needs.

PURPOSE OF THE RESEARCH STUDY
The purpose of this study is to learn about your satisfaction with a new implant connector type called Novaloc. We will attach it to a single implant in your lower jaw, and compare it to a traditional type called Locator. We will also ask which would be your preferred connector. We plan to ask you why you prefer one of these connectors in an interview.
Secondary purposes are to compare connectors according to: (1) how well your dentures will work from the dentist's viewpoint; (2) estimated cost of the treatment.
For this research study, we will recruit 26 participants, men and women, aged 65 years or more.

Duration and number of visits
Your participation in this research project will last 18 months and will include 06 visits. Each visit will last around 90 minutes.

Study devices
When participating in this research project, you will be assigned to one of the following groups: Group 1: Novaloc component, followed by the traditional (Locator) component (3 months each) Group 2: Traditional (Locator) component, followed by Novaloc (3 months each) The traditional component used in this research study looks very similar to Novaloc, except for the color and few details in shape. We are using a well-known component to compare with the new type (Novaloc) to ensure that the differences you report for them, good or bad, are not only due to chance. Plus, we will be able to see if Novaloc really provides advantages to justify its use (it is more expensive than Locators). In this information and consent form, the use of "study device" refers either to the implant component of interest (Novaloc) or to the traditional component (Locator). After you try both study devices, we will ask you to choose one to keep.
Furthermore, this study is randomized which means that you will be assigned to one of the groups. You may not choose the group to which you will be assigned; this process is done randomly like flipping a coin. One person out of 2 (50%) will receive Novaloc first whereas one person out of 2 (50%) will receive Locator first. This is a single blind study, which means that the researchers who will make questions will not know which component you will have during this project. In case of emergency, the study doctor will have access to this information.

Tests and procedures
During your participation in this research study, the study doctor or a member of the research team will conduct the following tests and procedures:

DESCRIPTION OF STUDY PROCEDURES Procedure Description
1. Screening -Initial questionnaire, mouth exam (as the standard of care) -Consent form (only for the study) 2. X-rays -X-rays to confirm that your jaw can receive implants (as the standard of care) 3. Implant insertion -Minor oral surgery for insertion of implant: we will numb your lower jaw to prevent pain. Then, we will prepare the jawbone and install the implant. We will place some stiches, and grind your denture above the implant (as the standard of care) 4. Implant follow-up -A brief appointment to see if your implant and surrounding gum are fine (a week after insertion) (as the standard of care) 5. Prosthetic modification -Hollowing your denture and installing retentive components (as the standard of care). This will be done at least 8 weeks after implant insertion. 6. Data collection -Questionnaires and mouth exam (only for the study) 7. Changing components -Grinding the denture base to remove a component and place another (only for the study) 8. Interview -You will discuss your feelings and preferences with the components and implant. This will happen in private and out of the clinic (only for the study) The schedule of procedures for each visit is listed below:

PARTICIPANT'S RESPONSIBILITIES
 As for standard dental treatment, please communicate if you cannot come to any of the scheduled appointments. Plus, please tell us if something changes in your health, even if that may not seem relevant.  Dentures and implants need regular care; please brush them at least twice/daily. We recommend you to see a dentist regularly after the end of the study, at least once/year.  You will be responsible for the costs of dental care after the study ends. Eventual repairs and changes of components will be necessary, as normal for dentures and implants. Fees may vary in different clinics, but you may expect fees of nearly $100 for repairing a component. Other repairs may be more expensive, such as refitting the denture with acrylic ($394 or more, depending on how it is done).

BENEFITS ASSOCIATED WITH THE RESEARCH STUDY
You may or may not personally benefit from your participation in this research project. However, we hope that the study results will contribute to the advancement of scientific knowledge in this field and help us find better treatments for patients.
All treatment involved in this study (implant, adapting your denture and changing components during the 18-month period) will be done free of charge.

RISKS ASSOCIATED WITH THE RESEARCH STUDY
Both study devices are licensed for patient use and sold in Canada and United States. This way, risks associated with treatment are the same expected for minor oral surgery and standard dental implants/dentures.
If you have noticed side effects, whatever they may be, during this research study, you must tell the study doctor immediately, regardless of whether you think these effects are related to the implants or components. Even once your participation in the study is over, do not hesitate to contact the study doctor if you experience a side effect that may be linked to the study devices.
The study doctor and members of his or her team will answer any questions that you may have regarding the risks, discomforts and side effect associated with this study. Also, at each visit, the s tudy doctor and members of his or her team will ask you questions about any side effects you may have experienced.

Risks associated with implant insertion
Prior to implant placement, you will receive an anesthetic injection to reduce sensitivity to pain. An allergic reaction to the injection is rare, although possible. If this occurs, safe, standard procedures will be followed. These could include providing anti-histamines and / or adrenaline.
You may experience a change in, or loss of, feeling in your lips, gums, and/or chin after implant placement. This is usually temporary. Some soreness may occur in the gums where the implants are placed, but this discomfort should be minimal and disappear within a few days. An over-the-counter medication (e.g.: aspirin, Tylenol) should control that pain.

Risks associated with dentures
You may experience some sore spots under your dentures after the placement of implants or retentive components. If this happens, the dentures will be adjusted for you as necessary. Allergic reactions to dental materials (such as the acrylic mixture used to bond components and denture) are rare but might also occur.
Your lower denture might break after the installing retentive components inside it. If this happens during the study timeline, we will fix/repair it at no cost.

Other risks
Losing an implant is uncommon but possible. If your implant is lost or does not attach to the bone, it will be replaced. If it happens, you might opt to return to a conventional denture; we will do it for you if needed. Implants can become loose, causing the gums to become sore or infected. If this occurs, the implant will be removed and, if necessary, an antibiotic can be taken for the infection.
We do not expect risks or complications from the x-rays or other exams. This includes data collection and interviews.

RISKS ASSOCIATED WITH PREGNANCY
This study presents no risk of this type due to the minimum age for participation (65 years).

OTHER POSSIBLE TREATMENTS
You do not have to take part in this study to receive medical care for your condition. Other options exist such as: (1) new full dentures or repairs ("relinings"); (2) more than one implant in the lower jaw; (3) implants in the upper jaw. We encourage you to discuss with the study doctor all available options.

VOLUNTARY PARTICIPATION AND THE RIGHT TO WITHDRAW
Your participation in this research project is voluntary. Therefore, you may refuse to participate. You may also withdraw from the project at any time, without giving any reason, by informing the study doctor or a member of the research team.
Your decision not to participate in the study, or to withdraw from it, will have no impact on the quality of care and services to which you are otherwise entitled, or on your relationship with the study doctor or clinical team.
The study doctor, the Research Ethics Board, the funding agency, or the Sponsor may put an end to your participation without your consent. This may happen if new findings or information indicate that participation is no longer in your interest, if you do not follow study instructions, or if there are administrative reasons to terminate the project.
However, for safety and future result analyses, before you withdraw from the study we ask you to notify the contact person in the research team, verbally or in writing.
If you withdraw or are withdrawn from the study, the information and biological material already collected for the study will be stored, analyzed and used to ensure the integrity of the study.
Any new findings that could influence your decision to stay in the research project will be shared with you as soon as possible.

CONFIDENTIALITY
During your participation in this study, the study doctor and their team will collect and record information about you in a study file. They will only collect information required to meet the scientific goals of the study.
The study file may include information from your medical chart, including your identity, concerning your past and present state of health, your lifestyle, as well as the results of the tests, exams , and procedures that you will undergo during this research project. Your research file could also contain other information, such as your name, sex, date of birth and ethnic origin.
The research forms and x-rays will be sent to Dr. de Souza's office and stored for 25 years for the exclusive objectives of this study and then destroyed. His office is located at McGill University, Faculty of Dentistry, 2001 McGill College Ave, suite 534, H3A1G1, Montreal (QC).
All the information collected during the research project will remain strictly confidential to the extent provided by law. You will only be identified by a code number. The key to the code linking your name to your study file will be kept by the study doctor.
To ensure your safety, a copy of this information and consent form (including the type of implant/components in use and x-ray results) will be placed in your medical chart. As a result, any person or company to whom you give access to your medical chart will have access to this information.
The study doctor will forward your coded data to the sponsor or their representatives.
The Sponsor may share the coded study data with their commercial partners. However, the sponsor and any international partners will respect the confidentiality rules in effect in Quebec and Canada, regardless of the country to which your data may be transferred.
The study data will be stored for 25 years by the principal investigator (Dr de Souza).
The data may be published or shared during scientific meetings; however it will not be possible to identify you.
For monitoring, control, safety, security, and marketing of a new study drug, your study file as well as your medical charts may be examined by a person mandated by Canadian or international regulatory authorities, such as Health Canada, as well as by representatives of the study sponsor, the institution, or the Research Ethics Board. All these individuals and organizations adhere to policies on confidentiality.
You have the right to consult your study file in order to verify the information gathered, and to have it corrected if necessary.
However, in order to protect the scientific integrity of the research project, accessing certain information before the project is ended may require that you be withdrawn from the study.

INCIDENTAL FINDINGS
Material incidental findings are findings made in the course of the study that may have significant impacts on your current or future wellbeing or that of your family members. A material incidental finding concerning you in the course of this research will be communicated to you and to a health professional of your choice.
We will exam you according to standard practices in dentistry during "visit 1". This may reveal certain diseases that are outside our study goals but have importance for your well-being. Examples are: (1) infection of your mouth; (2) tumours or cysts only visible by x-ray. We will tell you about such a finding and refer you to adequate treatment when needed. This will happen regardless of your inclusion or not in this study. If we have any incidental finding during any visit, we will do the same.

MARKETING POSSIBILITIES
The research results, including those following your participation in this study, could lead to the creation of commercial products. However, you will not receive any financial benefits.

FUNDING OF THE RESEARCH PROJECT
The study doctor and the institution have received funding from the sponsor for the completion of the research project.

COMPENSATION
You will receive an amount of 25$ per study visits 5, 6 and 7, for a total of 03 visits, for a total amount of 75$ for costs and inconveniences incurred during this research study. If you withdraw from the study, or are withdrawn before it is completed, you will receive compensation proportional to the number of visits you have completed. Implant insertion and placement of components will be offered to you for free for the duration of this research study.

SHOULD YOU SUFFER ANY HARM
Should you suffer harm of any kind following administration of the study drug, or following any other procedure related to the research study, you will receive the appropriate care and services required by your state of health.
By agreeing to participate in this research project, you are not waiving any of your legal rights nor discharging the study doctor, the sponsor or the institution, of their civil and professional responsibilities.

CLINICAL TRIAL REGISTRATION
A description of this clinical trial is available on http://www.ClinicalTrials.gov (project NCT03126942). This Website will not include information that can identify you. At most, the Website will include a summary of the results.
You can search this Website at any moment, or access https://clinicaltrials.gov/ct2/show/NCT03126942 directly.

CONTACT INFORMATION
If you have questions or if you have a problem you think may be related to your participation in this research study, or if you would like to withdraw, you may communicate with the study doctor or with someone on the research team at the following number: Mr. Nicolas Drolet, telephone: (514)  For any question concerning your rights as a research participant taking part in this study, or if you have comments, or wish to file a complaint, you may communicate with: (1) The Patient Ombudsman of the Montreal General Hospital at the following phone number: (514) 934-1934, ext. 44285.

OVERVIEW OF ETHICAL ASPECTS OF THE RESEARCH
The McGill University Health Centre Research Ethics Board reviewed this study and is responsible for monitoring it at all participating institutions in the health and social services network in Quebec. Vous ne devriez PAS prendre part à cette étude si vous préférez porter des prothèses traditionnelles ou êtes tout à fait satisfait de vos prothèses actuelles.

Participation volontaire et droit de retrait
Votre participation est volontaire et en signant le présent formulaire de consentement, vous ne renoncez à aucun de vos droits prévus par la loi. De plus, vous ne libérez pas les chercheurs de leurs responsabilités juridiques et professionnelles.

Interruption de l'essai clinique
Le chercheur responsable du projet de recherche et le comité d'éthique de la recherche peuvent mettre fin à votre participation, sans votre consentement, si de nouvelles découvertes ou informations indiquent que votre participation au projet n'est plus dans votre intérêt, si vous ne respectez pas les consignes du projet de recherche ou s'il existe des raisons administratives d'abandonner le projet.
Le dentiste responsable de ce projet de recherche et les membres de son équipe de recherche répondront aux questions que vous pourriez avoir à ce sujet. De plus, à chaque visite, le dentiste responsable de ce projet de recherche et les membres de son personnel de recherche vous poseront des questions au sujet de tous les effets secondaires que vous auriez pu avoir.
Votre décision de ne pas participer à ce projet de recherche ou de vous en retirer n'aura aucune conséquence sur la qualité des soins et des services auxquels vous avez droit ou sur votre relation avec les équipes qui les dispensent.

CONFIDENTIALITÉ
Durant votre participation à ce projet de recherche, le dentiste responsable de ce projet ainsi que les membres de son personnel de recherche recueilleront, dans un dossier de recherche, les renseignements vous concernant et nécessaires pour répondre aux objectifs scientifiques de ce projet de recherche. Tous les renseignements recueillis demeureront confidentiels dans les limites prévues par la loi. Vous ne serez identifié que par un numéro de code. La clé du code reliant votre nom à votre dossier de recherche sera conservé par le dentiste responsable de ce projet de recherche.
Vous avez le droit de consulter votre dossier de recherche pour vérifier les renseignements recueillis et les faire rectifier au besoin.

FINANCEMENT DU PROJET DE RECHERCHE
Le dentiste responsable de ce projet de recherche ainsi que l'institution ont reçu un financement du commanditaire pour mener à bien ce projet de recherche.
En acceptant de participer à ce projet de recherche, vous ne renoncez à aucun de vos droits et vous ne libérez pas le dentiste responsable de ce projet de recherche, le commanditaire et l'établissement de leur responsabilité civile et professionnelle.