|PG FORUM/CRITICAL APPRAISAL
|Year : 2019 | Volume
| Issue : 1 | Page : 93-94
A multicentric randomized controlled trial to compare a self-ligating bracket with a conventional bracket in a UK population
Gaurav Pratap Singh, Abhishek Singla, Ashutosh Bhardwaj
Post Graduate Resident, Department of Orthodontics and Dentofacial Orthopaedics, Army Dental Centre (Research and Referral), New Delhi, India
|Date of Submission||17-Apr-2018|
|Date of Acceptance||21-Jul-2018|
|Date of Web Publication||04-Feb-2019|
Gaurav Pratap Singh
Department of Orthodontics and Dentofacial Orthopaedics, Army Dental Centre (Research and Referral), New Delhi
Source of Support: None, Conflict of Interest: None
|How to cite this article:|
Singh GP, Singla A, Bhardwaj A. A multicentric randomized controlled trial to compare a self-ligating bracket with a conventional bracket in a UK population. J Indian Orthod Soc 2019;53:93-4
|How to cite this URL:|
Singh GP, Singla A, Bhardwaj A. A multicentric randomized controlled trial to compare a self-ligating bracket with a conventional bracket in a UK population. J Indian Orthod Soc [serial online] 2019 [cited 2019 Apr 26];53:93-4. Available from: http://www.jios.in/text.asp?2019/53/1/93/251557
Part 1: Treatment efficiency
O'Dywer L, Littlewood SJ, Rahman S, Spencer RJ, Barber SK, Russell JS. A multicentric randomized controlled trial to compare a self-ligating bracket with a conventional bracket in a UK population: Part 1: Treatment efficiency. Angle Orthod 2015;86:142-8.
Part 2: Pain perception
Rahman S, Spencer RJ, Littlewood SJ, O'Dywer L, Barber SK, Russell JS. A multicentric randomized controlled trial to compare a self-ligating bracket with a conventional bracket in a UK population: Part 2: Pain perception. Angle Orthod 2015;86:149-56.
| Background|| |
Self-ligating bracket (SLB) systems are alleged to reduce friction between the bracket and archwire, thus improving treatment efficiency by reducing the number of appointments and overall treatment time. Most of the benefits are cited to reduce friction between the bracket and archwire. It has also been claimed that owing to the reduced friction, the resulting potential for light forces should reduce pain from the pulp and periodontal ligament. However, if the SLB system is to show a substantial cost-to-benefit ratio, the reduced friction must be proven clinically as well as in vivo. Previous systematic reviews on this subject have highlighted the need for better quality evidence in the form of CONSORT-regulated randomized controlled trials.
| Aim|| |
The aim of Part I of this study was to determine whether a SLB system (3M SmartClip™) increases the efficiency of treatment as compared to brackets using conventional ligation (3M Victory™).
The aim of Part II of this study was to compare patients' perception of pain and discomfort between the above-mentioned two appliance systems.
| Materials And Methods|| |
A two-arm prospective parallel multicentric trial was carried out to find the treatment efficiency between a self-ligating (3M SmartClip™) and a conventional preadjusted edge-wise appliance system (3M Victory™). Treatment efficiency was evaluated in terms of total treatment time, number of visits, and bracket bond failure rate. The outcome of perception of pain/discomfort was measured using a questionnaire given to all patients, which used a verbal rating scale of “none,” “mild,” “moderate,” and “severe.” All patients requiring upper and lower fixed appliance treatment using preadjusted edge-wise appliances were invited to participate in the study. A total of 138 patients agreed to participate in the trial out of which 135 completed the trial. Among those who completed the trial, 113 patients returned the necessary pain data.
| Results|| |
The results showed that no difference was found in treatment efficiency between the two appliance systems, measured in terms of number of visits required and overall treatment time. Regarding bond failure, there was no statistical difference between both appliance systems. In the evaluation of pain perception, no clinically significant difference was identified in this study.
| Conclusion|| |
No difference was found between SmartClip™ SLBs and conventional victory™ brackets with regard to the number of visits, overall treatment time, and pain perception. Small differences in treatment time were found between the treatment centers; however, these were not statistically and clinically insignificant.
| Reviewer's Comments|| |
- The study under review is a two-arm prospective parallel multicentric randomized controlled trial which is under Category 1 of GRADE guidelines of evidence. The title of the study is descriptive and detailed. It provides an indication of the study design as well as the population under study. The article is present in the IMRD format. The introduction is meaningful and concise with a seminar type of approach. Of particular relevance in the introduction is a tabled review of previous studies evaluating SLB with conventional appliance systems. This is highly informative and a ready reference. The review of literature is comprehensive. The sample size is higher than any of the previous randomized controlled or prospective clinical trials
- The strengths of the study include a high level of evidence, single blinding, high sample size, low dropout, and adherence to CONSORT guidelines. The authors have also discussed the limitations of the study in the text, which is very balanced
- Limitations include that results apply to a specific population and a specific bracket system with a particular archwire sequence. Another point is that the results show that SLBs have a lower bond failure rate than conventional brackets; however, in the discussion, the authors state that SLBs have a higher bond failure rate. Part II of the study deals with pain perception; however, the data could have been presented as one paper to avoid repetition of text. The authors used a questionnaire to measure pain that had not been validated. Another point was that the authors powered the study on treatment efficiency data only. Unfortunately, they did not carry out a similar power calculation for pain. This means that they had sufficient power to detect a difference in treatment efficiency but not for pain
- Overall, this study does add information that suggests that there are no or minimal advantages to the use of SLBs.