Contemporary approaches advocate user involvement in research involving participants throughout the design, conduct and reporting of the research process . Indeed, evidence of patient and public involvement is a mandatory requirement of many ethical committees worldwide and funding bodies including the US National Institutes for Health and the UK National Institute for Health Research. Many benefits of user involvement in research have been described; these include research which is more relevant to the needs of patients , improved prioritization of research areas to optimize patient benefit , studies that are more appropriately designed, particularly in terms of outcome measures, better recruitment [4, 5] and enhanced implementation of the research findings . Other benefits of involving service providers in research, particularly in feasibility studies for clinical trials, include identification of potential barriers to recruitment of both clinicians and patients , the management of patients’ and providers’ intervention preferences and identification of resources required to ensure thatthe trial runs smoothly and in a timely fashion .
To date, there is little evidence of involvement of patients and the public in the design, conduct or dissemination of dental research. A recent study that sought to identify potential factors that might contribute to parent participation in a gene bank for patients with orofacial clefts found that reassurance from trusted healthcare professionals about the purpose of the project was particularly important . Another qualitative study of primary care dentist and dental care professionals’ involvement in prospective studies and clinical trials cited cultural, medico-legal and commercial concerns that acted as barriers to their involvement. Several specific difficulties raised have been ethical concerns about clinical equipoise, time commitment  and recruitment of suitable patients [8, 9]. However, the involvement of service providers and users to contribute to the design of a dental trial has not previously been described.
Within the UK, the lack of evidence for the effective management of dental caries (decay) in children’s primary teeth causes considerable uncertainty for the dental profession and patients. Current clinical guidelines produced by the British Society of Paediatric Dentistry [10, 11] are largely based on evidence for the effectiveness of restorations obtained from studies conducted in either a secondary care or specialist pediatric practice setting. While both the volume and quality of the research on which the guidance is based is limited, it is acknowledged that restorations provided in specialist clinical environments can be effective . However, it is the generalizability of this evidence to a primary care setting which is in question, particularly as the majority of dental care for children is provided in primary care by general dental practitioners (GDPs).
To address this lack of evidence, a multi-center team sought funding from the National Institute for Health Research to undertake a randomized controlled trial (RCT), the findings of which will have considerable national and international impact. The trial entitled ‘Filling Children’s Teeth: Indicated Or Not?’ (FiCTION) is a three arm parallel design RCT which examines the relative clinical and cost effectiveness, in the primary care dental practice setting, of three different approaches to the management of caries in primary teeth. The three arms are:
surgical’: based on the traditional ‘drill and fill’ approach where local anesthesia is given, caries is completely removed and a restorative material (filling or crown) is placed;
biological’: an intermediate treatment where strategies to seal-in caries are used to stop its progression, including the use of Hall Technique preformed metal crowns;
prevention alone’, a best practice preventive program (which is also incorporated into the other two arms) .
Before the FiCTION main trial commenced, a pilot trial was carried out to ensure the main trial was practicable, particularly in terms of patient recruitment/retention rates and collection of data on clinical outcomes. Service providers’ (dentists and other members of the team including dental nurses and practice managers) and participants’ (child participants and their parents) involvement was incorporated into the pilot trial. Very few clinical trials involving children have been conducted in the primary dental care setting in the UK or worldwide. The findings of the pilot RCT were then used to refine the design and conduct of the main trial.
The aim of this study is to describe service providers’ and users’ perspectives on the FiCTION pilot trial to improve the design and conduct of the FiCTION main trial. This paper reports on these perspectives and the resultant changes to the FiCTION main trial.