CONSORT Randomized Clinical TrialClinical Effectiveness of Basic Root Canal Treatment after 24 Months: A Randomized Controlled Trial
Section snippets
Patients and Methods
This was a clinical, multicenter, controlled, open-label trial to evaluate the effectiveness of BRT after 24 months. The study protocol was approved by the Witten/Herdecke University institutional review board (no. 13/2007) and the Department of State for Health and Social Welfare of the Republic of the Gambia. All participants gave written informed consent with the assistance of a native speaker before study-related procedures were performed. Figure 1 describes the study design in brief.
Results
Thirty-eight eligible participants were recruited in 2010 and allocated to the test group according to the block randomization protocol, and 33 eligible participants were recruited in 2011 and allocated to the control group. There was 1 treatment protocol deviation in a man in the control group who was endodontically treated in a lower first molar. During follow-up, there were 13 protocol deviations because of a lack of temporary power supply. Therefore, in 11 test group participants and 1
Discussion
This study showed that the BRT approach with tactile working length determination as compared with the standard radiographic working length control did not significantly differ in terms of radiographic and clinical outcomes after 24 months. Apical extension of the root canal fillings as well as periapical anatomic structures showed no significant differences according to radiographic analyses. Corresponding results were found in clinical aspects of tooth tender to percussion and tooth loss.
Conclusion
Within the limits of this randomized controlled trial, it was shown that tactile working length determination in BRT resulted in comparable treatment outcomes in radiographic and clinical aspects compared with standard endodontic treatment with radiographic working length determination. Tactile working length determination turned out to be an accurate method in BRT.
Acknowledgments
We would like to thank Igor Zibold and Daniel Hesse for their organizational and operative contribution to the study.
The basic root canal treatment program was supported by Voco (Cuxhaven, Germany). Voco had no bearing on the conduction of this study and was excluded from other matters, including analyzing the data and reporting the results.
The authors deny any conflicts of interest related to this study.
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Rainer A. Jordan and Anna L. Holzner contributed equally to this work.