Non-Surgical Submarginal Instrumentation of Peri-Implant Mucositis With Delivery of Sodium Hypochlorite/Amino Acids and Cross-Linked Hyaluronic Acid: A Randomized Clinical Trial.
Publisher DOI
PubMed ID
41761442
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.
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.
Date Issued
2026-05
Publication Type
Article
Subject(s)
Subjects
antiseptics
•
biofilm
•
hyaluronic acid
•
inflammation
•
mucositis
•
sodium hypochlorite
Language(s)
en
Author(s)
Iorio-Siciliano, Vincenzo | |
Blasi, Andrea | |
Windisch, Peter | |
Ramaglia, Luca |
Additional Credits
Journal
Clinical Oral Implants Research
Publisher
Wiley
ISSN
1600-0501
0905-7161
Access(Rights)
open.access