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.

An unusual case of floor of mouth swelling: case report, differential diagnosis and a review of the literature.

UNLABELLED: The oral cavity is an uncommon site for a true lipoma. A distinct histological variant is the spindle cell lipoma. This is a rare oral lesion. A case of an intra-oral spindle cell lipoma in a 55-year-old female is reported, a differential diagnosis is presented and the histopathology is discussed. CLINICAL RELEVANCE: An oral swelling is a common presenting complaint and requires further investigation.

The efficacy of a plasma arc light in orthodontic bonding: a randomized controlled clinical trial.

OBJECTIVE: To evaluate the clinical performance of a plasma arc light (Ortho LITE, 3M Unitek, Monrovia, CA, USA) against a conventional tungsten-quartz halogen curing light (Visilux 2, 3M Unitek, Monrovia, CA, USA) for direct orthodontic bonding. DESIGN: A single centre prospective randomized controlled clinical trial. SETTING: The Orthodontic Department at St Luke's Hospital, Bradford, UK. SUBJECTS AND METHODS: Forty-three consecutive patients requiring fixed appliances from the orthodontic waiting list. A split mouth technique was adopted; with quadrants randomly assigned to either the plasma arc light or the conventional halogen curing light and bonded directly with APC pre-adjusted edgewise brackets (3M Unitek, Monrovia, CA, USA). MAIN OUTCOME MEASURE: Bracket failures. SECONDARY OUTCOME MEASURES: Time taken to bond-up the appliances, patient sensitivity or discomfort during curing and time to replace failed brackets were investigated. RESULTS: No statistically significant difference in bracket failure rates over the full course of treatment was found between the plasma arc light (6.7%; 95% CI 4.5-10.0) and the halogen curing light (9.5%; 95% CI 6.8-13.1). There was no statistically significant difference in bracket survival times. The bond-up times were typically reduced by 204 seconds per patient with the plasma arc light. There were no differences in patient reported sensitivity or discomfort or rebond times. CONCLUSION: The plasma arc light is a viable clinical alternative to the conventional halogen curing light with benefits for both the clinician and patient due to reduced bonding times.