Significance of barrier membrane on the reconstructive therapy of peri‐implantitis: A randomized controlled trial
Alberto Monje, Ramón Pons, Javi Vilarrasa, José Nart, Hom‐Lay Wang
Abstract
Abstract 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).