A multicenter randomized controlled trial to compare a self-ligating bracket with a conventional bracket in a UK population: Part 2: Pain perception.

OBJECTIVE: To compare pain experience between self-ligating and conventional preadjusted edgewise appliance systems with a two-arm parallel trial. MATERIALS AND METHODS: A prospective multicenter randomized controlled clinical trial was conducted in three hospital orthodontic departments. Subjects were randomly allocated to receive treatment with either a self-ligating (3M SmartClip™) or conventional (3M Victory™) bracket system with stratification for operator and center. Standardized protocol was followed for bracket bonding procedure and archwire sequence. Subject pain was recorded using a Verbal Rating Scale to assess discomfort felt on the teeth and soft tissues at the time of the appointment and 1, 3, and 5 days after each archwire change up to the working archwire. Multilevel modeling was used to analyze the data by blinded assessors. RESULTS: One hundred thirty-eight subjects (mean age 14 years 11 months) were enrolled in the study, of which 135 subjects (97.8%) completed the study and 113 (82%) returned the required data regarding pain/discomfort. Perceived pain was statistically higher with the SmartClip™ system compared to the Victory™ system, but this difference was not deemed to be clinically significant. Discomfort was greatest after placement of the initial 0.014-inch nickel-titanium archwire, compared with subsequent wires, and was greatest on day 1, less on day 3, and much less on day 5 after each archwire change. Age and gender did not affect the level of discomfort experienced by subjects undergoing fixed appliance treatment. CONCLUSION: No clinically significant difference in pain experience was found between patients treated with a self-ligating bracket system compared to those treated with a conventional ligation system.

A multi-center randomized controlled trial to compare a self-ligating bracket with a conventional bracket in a UK population: Part 1: Treatment efficiency.

OBJECTIVE: To use a two-arm parallel trial to compare treatment efficiency between a self-ligating and a conventional preadjusted edgewise appliance system. MATERIALS AND METHODS: A prospective multi-center randomized controlled clinical trial was conducted in three hospital orthodontic departments. Subjects were randomly allocated to receive treatment with either a self-ligating (3M SmartClip) or conventional (3M Victory) preadjusted edgewise appliance bracket system using a computer-generated random sequence concealed in opaque envelopes, with stratification for operator and center. Two operators followed a standardized protocol regarding bracket bonding procedure and archwire sequence. Efficiency of each ligation system was assessed by comparing the duration of treatment (months), total number of appointments (scheduled and emergency visits), and number of bracket bond failures. RESULTS: One hundred thirty-eight subjects (mean age 14 years 11 months) were enrolled in the study, of which 135 subjects (97.8%) completed treatment. The mean treatment time and number of visits were 25.12 months and 19.97 visits in the SmartClip group and 25.80 months and 20.37 visits in the Victory group. The overall bond failure rate was 6.6% for the SmartClip and 7.2% for Victory, with a similar debond distribution between the two appliances. No significant differences were found between the bracket systems in any of the outcome measures. No serious harm was observed from either bracket system. CONCLUSIONS: There was no clinically significant difference in treatment efficiency between treatment with a self-ligating bracket system and a conventional ligation system.

A case of facial swelling and proptosis.

A case of high-grade B cell lymphoma of the maxillary sinus in a 74-year-old Caucasian male patient is described. Initial presentation of the tumour commonly simulates odontogenic infection. Dental surgeons should maintain a high degree of suspicion for early diagnosis of maxillary sinus tumours. Appropriate use of CT scans and surgical biopsy is essential in the management of such cases.