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

ABSTRACT 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