Comparison of patient acceptance of the Forsus Fatigue Resistant Device with and without mini-implant anchorage: A randomized controlled trial

• We aimed at assessment of the patients' acceptance to the mini- implants anchored Forsus Fatigue Resistant Device (FFRD) in comparison with the conventional FFRD.
• No significant differences were reported between groups regarding the ease of appliance insertion, noticeability by others, pain, swelling, effect on eating, speech, and sleep, and gum bleeding.
• The patients were highly satisfied with the treatment results and reported no significant functional limitations.
• The mini-implants anchored FFRD and the FFRD could be considered equally accepted by the patients.

IntroductionThe objective of this 2-arm parallel randomized controlled trial was to evaluate patient acceptance of the mini-implant anchored Forsus Fatigue Resistant Device (FFRD) (3M Unitek, Monrovia, Calif).MethodsThe study included 32 skeletal Class II girls. The eligibility criteria included a deficient mandible, a horizontal or neutral growth pattern, an increased overjet, and a full set of erupted permanent teeth. After the leveling and alignment stage, FFRDs and mini-implants were inserted; they were removed after the teeth reached an edge-to-edge incisor relationship. The patients were afterward asked to fill out assessment questionnaires regarding their experience with the FFRD.OutcomesThe primary outcome of this study was to assess patient acceptance of the appliance and satisfaction with the results. The secondary outcomes were interference with functional activities, noticeability by others, pain, swelling, gum problems caused by the appliance, and appliance breakage.RandomizationComputer random sequence generation was done using block sizes of 6 and 4. Allocation concealment was achieved with sequentially numbered opaque sealed envelopes.BlindingBlinding of the clinicians and the patients to the intervention was impossible, but it was done for the outcome assessment and the statistician.ResultsThe 32 patients were randomly allocated in a 1:1 ratio into 2 groups: 16 patients (mean age, 13.25 ± 1.12 years) received the FFRD alone (FFRD group), and 16 patients (mean age, 13.07 ± 1.41 years) had mini-implants in conjunction with FFRDs (FMI group). No statistically significant differences were reported between the 2 groups regarding ease of appliance insertion, noticeability by others, pain, swelling, effects on eating and speech, and gum bleeding; 100% and 87.5% were satisfied with the results in the FFRD and FMI groups, respectively, with a ridit value of 0.57 (95% confidence interval, 0.43-0.71; P = 0.36). No serious harm was observed other than swelling of the cheeks, which occurred in 4 patients.ConclusionsThere were no significant differences between the patients’ acceptance of the FFRD and the mini-implant anchored FFRD. They were highly satisfied with the results. Neither group reported significant functional limitations.RegistrationThis trial was not registered.ProtocolThe protocol was not published before trial commencement.FundingThe study was self-funded by the authors.