Perception of pain in Class II malocclusion children treated with cervical headgear: a randomized controlled trial.

OBJECTIVES: The aims of this study were: 1. to evaluate the experience of pain perceived by children during separator placement and headgear wear; 2. to find possible associations between the perceived intensity of pain and the levels of Substance P (SP) and interleukin-1 beta (IL-1ß) in the gingival crevicular fluid (GCF) during these procedures; 3. to identify other factors, such as previous pain experience, which could be associated to the patients' perceived discomfort or pain during treatment. TRIAL DESIGN: Nine-month parallel-group randomized controlled trial. METHODS: Forty Class II malocclusion children (8-12 years) were included, half of which received a cervical headgear while the other half did not receive any treatment during the study period. Baseline pain data were recorded including previous experience to general and dental pain, Corah's Dental Anxiety Scale, and baseline pain using a visual analogue scale (VAS). Elastic separators were placed in children for 1 week, followed by molar band and cervical headgear placement. Children were seen at various time points throughout the 9-month period where at each appointment, a VAS assessment of pain as well as GCF sampling was carried out to quantify the levels of SP and IL-1ß. Multiple regression analysis was performed to ascertain the influence of factors including sex, age, time, headgear wear, and baseline pain data on pain severity. RESULTS: Pain severity and SP and IL-1ß levels in the GCF follow a similar pattern, with peaks being observed 1 day after orthodontic elastic separator placement. Pain was more severe after the placement of orthodontic separators than following cervical headgear wear. With regard to pain predictors, pain is more severe in older children, those with a worse previous general pain experience, and those with higher levels of IL-1ß, particularly after elastic separator placement. CONCLUSIONS: Orthodontic pain and discomfort following orthodontic separator placement and cervical headgear wear depends on factors including age, previous pain experience, and the level of IL-1ß in the GCF.

Headgear compliance as assessed by a temperature-sensitive recording device: a prospective clinical study.

OBJECTIVE: To accurately describe compliance in headgear wearing time by using a temperature- and force-sensitive device over an 8 month period of use in a prospective clinical manner. MATERIALS AND METHODS: Twenty children with Class II malocclusion aged 8-12 years were randomly selected for treatment with cervical headgear. The headgears were equipped with an electronic module, which measured temperature and force, and patients were instructed to wear the headgear 12 hours daily. The recorded values were analysed to determine the number of days the headgear was used, the number of hours per day it was worn, and the percentage of compliance (100 per cent corresponding to 12 hours daily). RESULTS: The average treatment period was 8.4 months with 5.8 months of effective use. When effectively used, headgear was worn 8.7 hours a day (compliance of 73 per cent). Including days where it was not worn, compliance was 6.4 hours (54 per cent). The appliance was used on average 0.5 hours during the day (8 am-8 pm) and 5.9 hours during the night (8 pm-8 am). Very low compliance was recorded during July and August. CONCLUSION: The average compliance with cervical headgear use was 54 per cent of the 12 hour prescription. The headgear was effectively used only 5.8 months over the study period, with roughly 30 per cent of no use. Headgear was used almost exclusively during evening and night-time. During the summer period, compliance was particularly poor.