Non-Surgical Submarginal Instrumentation of Peri-Implant Mucositis With Delivery of Sodium Hypochlorite/Amino Acids and Cross-Linked Hyaluronic Acid: A Randomized Clinical Trial

Objectives: To evaluate the effects of submarginal instrumentation (SI) with or without adjunctive delivery of sodium hypochlorite (NaOCl)/amino acids and cross-linked hyaluronic acid (xHyA) gel in the treatment of peri-implant mucositis (PM). Material and methods: Forty implants supporting single-unit crowns diagnosed with PM in 40 patients were randomly assigned to test (SI + NaOCl/amino acids and xHyA) or control group (SI alone). The primary outcome was mean BoP change. Full-Mouth Plaque Score (FMPS), Full-Mouth Bleeding Score (FMBS), modified plaque index (mPlI), and probing depth (PD) were assessed as secondary outcomes. Clinical parameters were assessed at baseline, 3 and 6 months. Disease resolution was also recorded. Results: Two patients were lost during follow-up while 38 patients completed the study without adverse effects. After 6 months, all clinical parameters improved statistically significantly in both groups (p < 0.05). The change in mean BoP at 1, 3, and 6 months was 72.2% ± 24.3%, 70.4% ± 24.3%, and 63.0% ± 24.6% for test group and 70.0% ± 19.9%, 66.7% ± 24.8%, and 56.7% ± 30.8% for control group. The mean BoP change in experimental procedure was statistically significant at all investigation time points (p < 0.05). Regarding disease resolution, implants with initial PD ≤ 4 mm did not show differences among groups (p > 0.05); conversely, an initial PD = 5 mm yielded a statistically significant difference (p < 0.05). Disease resolution correlation with test group was statistically significant with a 3.77 odds ratio. Conclusion: Within the limitations of the present study, adjunctive delivery of NaOCl/amino acids and xHyA to SI yielded superior clinical outcomes compared with SI alone in the treatment of PM. Trial registration: ClinicalTrials.gov: NCT05926297.