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RESEARCH PRODUCT

Implants in free fibula flap supporting dental rehabilitation - Implant and peri-implant related outcomes of a randomized clinical trial.

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Abstract Objectives The objective of this study was to assess the difference in success rates of implants when using two or four implant-supported-overdentures following segmental mandibular reconstruction with fibula free flap. Methods and designs This prospective, parallel designed, randomized clinical study was conducted with 1:1 ratio. At baseline, all participants already had segmental reconstruction of mandible with free fibula flap. The participants were randomized into two groups: Group-I received implant-supported-overdentures on two tissue-level implants and Group-II received implant-supported-overdentures on four tissue-level implants. Success rates of the implants were evaluated at 3 months, 6 months and 12 months following implant loading using marginal bone level changes as well as peri-implant indices (Buser et al., 1990). Results 52 patients were randomized into two treatment groups (26 each), out of which 18 patients (36 implants) of Group-I and 17 patients (68 implants) of Group-II were evaluated. One implant in Group-I was lost due to infective complications and one patient in the same group had superior barrel necrosis. There was a statistically significant increase at both time points (p = 0.03, p = 0.04 at 6 months, 12 months) in the amount of marginal bone loss in Group-I (0.4 mm, 0.5 mm at 6 months, 12 months) as compared to Group-II (0.1 mm, 0.2 mm at 6 months, 12 months). There were no clinically significant changes peri-implant parameters between both groups. Peri-implant soft tissue hyperplasia was seen in both groups, 32% of implants at 3-months, 26% at 6-months and 3% at 12-months follow-up. Conclusion The results of this study show that patients with 2-implant-supported-overdentures had higher marginal bone loss as compared to patients with 4-implant-supported-overdentures. There were no clinically significant differences in peri-implant soft tissue factors in patients with 2- or 4-implant-supported-overdentures. Hyperplastic peri-implant tissues are common in the early implant-loading phase and tend to decrease over time under appropriate management.