Anti-infective therapy of peri-implant mucositis with adjunctive delivery of a sodium hypochlorite gel: a 6-month randomized triple-blind controlled clinical trial

Abstract

Objective: To evaluate the effects of adjunctive delivery of a sodium hypochlorite gel in the treatment of peri-implant mucositis (PM). Materials and methods: Forty-six subjects with 68 implants diagnosed with PM were randomly assigned to two treatment groups. Prior to mechanical debridement, a sodium hypochlorite gel was delivered to the implants of the test group while implants of the control group received a placebo gel. Application of both test and placebo gels was repeated 5 times at baseline. The primary outcome variable was the change in pocket probing depth (PPD) between baseline and 6 months. Results: After 6 months, the mean PPD decreased statistically significantly from 3.93 ± 1.09 mm to 3.04 ± 0.46 mm in the test (p = 0.0001) and from 3.68 ± 0.85 mm to 3.07 ± 0.58 mm in the control (p = 0.0001) group, respectively. No statistically significant difference (p = 0.53) was observed with respect to PPD changes from baseline to 6 months between test (0.88 ± 1.04 mm) and control group (0.61 ± 0.75 mm), respectively. The number of implants with bleeding on probing (BoP) decreased statistically significantly from 33 to 18 in the test group (p = 0.0001) and from 34 to 23 in the control group (p = 0.0001) after 6 months. Conclusions: In conclusion and within the limits of the present study, changes in PPD from baseline to 6 months were not statistically significantly different between groups. Complete resolution of mucosal inflammation was not achieved with either of the therapies. Clinical relevance: The present outcomes have showed that a complete resolution of peri-implant mucositis is not possible to obtain by means mechanical debridement with or without a sodium hypochlorite gel application.