Level | Reason | Consequence |
---|---|---|
Tooth | Complication | Complications leading to tooth loss will be counted as non-survival. Teeth with complications which allow the retention of the tooth will be count as non-success. Required follow-up treatments will be recorded and survived teeth will be followed up on. |
Lesion treated by other dentist | Tooth will be counted as non-success or non-survival. | |
Tooth exfoliation | The last observation will be carried forward. | |
Patient | Adverse or serious adverse events related to treatment or material | Counteractive measures will be taken and events documented. |
Patient and tooth will be censored and the last observation carried forward. | ||
The patient cannot be examined (lost to follow-up) | Patient and survived tooth or teeth will be censored and the last observation carried forward. | |
The patient decides to withdraw from the study. | Patient and tooth will be censored and the last observation carried forward. | |
Study | One to four patient(s) show adverse events related to treatment or material | Counteractive measures will be taken and events documented. |
Patient and tooth will be censored and the last observation carried forward. The study will be interrupted. | ||
More than four patients show adverse events or one patient shows a severe adverse event related to treatment or material | Counteractive measures will be taken and events documented. | |
The study will be terminated. All patients and available teeth will be marked as censored and the last observation carried forward. |