Treatment of large overjet in Angle Class II: division 1 XXXX with Andresen activators versus prefabricated functional appliances-a multicenter, randomized, controlled trial.

@entity1 @entity2632 @entity3457 @entity3232
OBJECTIVES: The purpose of this study was to compare the clinical effectiveness in reducing large overjet between a prefabricated functional appliance (PFA) and a slightly modified @entity3457 ( @entity3457 ). SETTING AND SAMPLE POPULATION: Public Dental Service, Gothenburg, Sweden. @entity1 , STUDY DESIGN, AND METHODS: A multicentre, prospective randomized clinical trial was conducted with @entity1 from 12 general dental practices. One hundred and five @entity1 with an Angle Class II, division 1 @entity3232 and an overjet of >= 6mm were eligible for the study. Eight @entity1 were excluded due to various reasons and the sample consisted thus of 97 subjects (44 @entity1 , 53 @entity1 ) with a mean age of 10.3 years. The study was designed as intention to treat and the @entity1 were randomly allocated by lottery to treatment with either a PFA or an @entity3457 . The PFA and @entity3457 group consisted of 57 subjects (28 @entity1 , 29 @entity1 ) and 40 subjects (16 @entity1 , 24 @entity1 ), respectively. Overjet, @entity2632 , lip seal, and sagittal molar relationship were recorded before, at the end of treatment and 1-year post-treatment. Blinding was not performed. The endpoint of treatment was set to overjet  <=3mm and after this a 6 months retention period followed. RESULTS: No significant difference was found in overjet, @entity2632 , sagittal relation, and lip seal between the two groups for the total observation period. The treatment of 40 (70 per cent) @entity1 with PFA and 21 (53 per cent) with @entity3457 were considered unsuccessful mainly due to poor compliance. LIMITATIONS: No cephalometric records were taken as only @entity1 -centred clinical outcome were used as an indicator for treatment success. The criteria of reduction of overjet to as low as 3mm could have affected the success rate. CONCLUSION: No difference in effectiveness could be shown between PFAs and AAs in correcting overjet, @entity2632 , sagittal molar relation, and lip seal. The success rate in treatment with both appliances is, however, low. REGISTRATION: This trial was registered in "FoU i Sverige" (http://www.fou.nu/is/sverige), registration number: 97131. PROTOCOL: The protocol was not published before trial commencement.
