Non-surgical Step 3 Periodontal Treatment With/Without Adjunctive Protocol - Pilot RCT.

Summary

Study conducted in patients recruited at private praxis setting after completed step 2 periodontal therapy. Residual pockets ≥4mm with positive bleeding or such \>5mm randomly allocated to either conventional subgingival re-instrumentation (controls) or to same mechanical treatment with adjectively applied hypochlorite/aminoacid gel for antiseptic reason followed by subginigival placement of cross linked hyaluronic acid gel for sealing the site after instrumentation. Re-evaluations at 3 and 9 months controlled for clinical parameters such as Periodontal Probing Depth (PPD) (CAL), Clinical Attachment Level, Gingival Recession (GR), Bleeding on Probing (BOP). The hypothesis is, sites treated with adjunctive protocol show greater PPD reduction and greater CAL gain at 9-month evaluation.

Timeline

Start

2022-08-01

Primary completion

2023-10-30

Completion

2024-02-29

Outcome

Met primary endpoint

paper At 9-month evaluation, PD reduction and CAL gain showed significant differences between the test and control group, favouring the adjunctive treatment. PMID 39235513 ↗

Publications

• Results Ramanauskaite E, Machiulskiene V, Shirakata Y, Dvyliene UM, Nedzelskiene I, Sculean A. Clinical evaluation of sodium hypochlorite/amino acids and cross-linked hyaluronic acid adjunctive to non-surgical periodontal treatment: a randomized controlled clinical trial. Clin Oral Investig. 2023 Nov;27(11):6645-6656. doi: 10.1007/s00784-023-05271-0. Epub 2023 Sep 23.
• Results Shirakata Y, Nakamura T, Setoguchi F, Imafuji T, Shinohara Y, Matsumura S, Iwata M, Noguchi K, Ramanauskaite E, Sculean A. Histological evaluation of nonsurgical periodontal treatment with and without the use of sodium hypochlorite / amino acids and cross-linked hyaluronic acid gels in dogs. Clin Oral Investig. 2024 Apr 27;28(5):281. doi: 10.1007/s00784-024-05674-7.
• Benyei L, Friedmann A, Ostermann T, Diehl D. Non-surgical treatment of residual periodontal pockets using sodium hypochlorite/amino acid gel and cross-linked hyaluronic acid-a 9-month pilot randomized controlled clinical trial. Clin Oral Investig. 2024 Sep 5;28(9):513. doi: 10.1007/s00784-024-05906-w.

Drugs

Indications