Significance of barrier membrane on the reconstructive therapy of peri-implantitis: A randomized controlled trial.

BACKGROUND: The objective of this trial was to investigate the clinical and radiographic significance of using a mixture of mineralized and demineralized allografts in combination (M) or not (NM) with a resorbable cross-linked barrier membrane in the reconstructive therapy of peri-implantitis defects. METHODS: A two-arm randomized clinical trial was performed in patients diagnosed with peri-implantitis that exhibited contained defects. Clinical parameters were recorded at baseline (T(0) ), 6 months (T(1) ), and 12 months (T(2) ). Radiographic parameters were recorded at T(0) and T(2) . A composite criterion for disease resolution was defined a priori. A generalized linear model of repeated measures with generalized estimation equation statistical methods was used. RESULTS: Overall, 33 patients (n(implants) = 48) completed the study. At T(2) , mean disease resolution was 77.1%. The use of a barrier membrane did not enhance the probability of disease resolution at T(2) (odds ratio [OR] = 1.55, p = 0.737). Conversely, the odds of disease resolution were statistically associated with the modified plaque index recorded at T(0) (OR = 0.13, p = 0.006) and keratinized mucosa width (OR = 2.10, p = 0.035). Moreover, women exhibited greater odds to show disease resolution (OR = 5.56, p = 0.02). CONCLUSION: Reconstructive therapy by means of a mixture of mineralized and demineralized allografts is effective in clinically resolving peri-implantitis and in gaining radiographic marginal bone level. The addition of a barrier membrane to reconstructive therapy of peri-implantitis does not seem to enhance the outcomes of contained bone defects (NCT05282667).