Treatment of peri-implant mucositis using spermidine and calcium chloride as local adjunctive delivery to non-surgical mechanical debridement: a double-blind randomized controlled clinical trial.

Objectives: To evaluate the effects of non-surgical mechanical debridement with or without adjunctive application of a gel with spermidine and sodium hyaluronate associated to a sealing gel (i.e. calcium chloride) in the treatment of peri-implant mucositis (PiM).

Materials And Methods: Forty patients with one implant with PiM were randomly allocated in test and control groups. Test implants were treated with non-surgical mechanical debridement and local unique application of spermidine and calcium chloride gel while control implants were treated using non-surgical mechanical debridement alone. The primary outcome was BOP change. FMPS, FMBS and PD were also assessed. For an Implant the presence of a single bleeding spot (1 site/implant without a continuous line or profuse bleeding) was considered as complete disease resolution.

Results: After 3 months, a statistically significant improvement of all parameters were recorded in each group (p < 0.05). However, no statistically significant differences were found between test and control procedures (p > 0.05). At 3 months, 85% of test implants and 70% of control implants resulted in disease resolution. Residual implants with PiM in control group displayed a greater number of BOP-positive sites when compared with those of test group (p < 0.05).

Conclusions: Whitin the limitations of the present study, results indicate that the clinical parameters improved following non-surgical mechanical debridement regardless the adjunct of spermidine and calcium chloride gel. Nevertheless complete resolution of PiM was not obtained in both experimental groups.

Clinical Relevance: Although no statistically significant differences were found between test and control procedures, the adjunctive application of spermidine and calcium chloride gel to non-surgical mechanical debridement may be considered in order to reduce the number of sites with BOP-positive.