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Background  To evaluate the clinical outcome and changes in posterior buccal soft tissue following implant restoration in groups with and without a free gingival graft (FGG) before implant placement.    Methods  Twenty-six individuals who required implant restoration and displayed lack of keratinized mucosa (KM) were recruited and assigned to the FGG group (with FGG before implant placement) or Control group (without FGG before implant placement) randomly. A screw-retained conventional implant restoration was performed for each patient. Peri-implant soft tissue was captured by an intraoral scanner and analyzed by an image processing software. Clinical parameters (plaque index, gingival index, probing depth, and bleeding on probing) were assessed at baseline and 1, 3, 6, and 12 months. Buccal soft tissue changes (mucosal margin, soft tissue thickness, and width of keratinized mucosa) on the buccal side of implant site were assessed at 1, 3, 6, and 12 months. Two-way ANOVA and Bonferroni test were used to analyze significant difference between groups at each time point (α = 0.05).    Results  The clinical parameters were lower in the FGG group than that in the Control group, although there were no significant differences between the two groups ( P  > 0.05). Peri-implant soft tissue collapsed and the changes (mucosal margin and soft tissue thickness) were significantly greater in the Control group than the FGG group ( P  < 0.05). Width of KM was larger in the FGG group than the Control group, although there was no significant difference between the two groups ( P  > 0.05).    Conclusions  Minimal peri-implant soft tissue changes occurred in two groups. Performing FGG before implant placement is a viable procedure to maintain peri-implant soft tissue but might not affect peri-implant health during 12 months follow-up. However, small sample size must be considered.   Trial registration  This study was retrospectively registered in the Chinese Clinical Trial Registry (Registration number: ChiCTR2000037954; Date of registration: 6 September 2020).

Effect of free gingival graft before implant placement on peri-implant health and soft tissue changes: a randomized controlled trial