Non-Surgical Treatment of Periodontitis With Adjunctive Sodium Hypochlorite/Amino Acids and Cross-Linked Hyaluronic Acid

Official title

Non-Surgical Treatment of Periodontitis With Adjunctive Sodium Hypochlorite /Amino Acids and Cross-Linked Hyaluronic Acid: Randomized Controlled Trial

Overview

The goal of this clinical trial is to learn if using sodium hypochlorite/amino acid gel, with or without cross-linked hyaluronic acid, as an addition to standard non-surgical periodontal therapy works to treat periodontitis in adults. It will also learn about the safety of these treatments. The main questions it aims to answer are: Does the adjunctive treatment reduce bleeding on probing, plaque index, and periodontal pocket depth? What medical or dental problems do participants have when receiving these treatments? Researchers will compare: Standard non-surgical periodontal therapy alone Standard therapy plus sodium hypochlorite/amino acid gel Standard therapy plus sodium hypochlorite/amino acid gel and cross-linked hyaluronic acid ("Clean and Seal" protocol) Participants will: Receive their assigned treatment during one clinical session per the study protocol Have clinical measurements taken before treatment and at three months after treatment Be monitored for any dental or medical adverse events related to the procedures

Detailed description

Detailed Description

This study is a randomized controlled clinical trial designed to evaluate the effectiveness of adjunctive therapies in the non-surgical treatment of periodontitis. The trial compares three groups:

Standard non-surgical periodontal therapy (scaling and root planing with oral hygiene instruction).

Adjunctive sodium hypochlorite/amino acid gel applied before mechanical debridement.

Adjunctive sodium hypochlorite/amino acid gel followed by cross-linked hyaluronic acid ("Clean and Seal" protocol) after mechanical debridement.

The study aims to assess whether the use of these adjunctive treatments provides additional clinical benefits beyond standard therapy, measured through periodontal parameters such as plaque index (PI), bleeding on probing (BOP), probing pocket depth (PPD), clinical attachment level (CAL), and gingival recession (GR).

Participants will be recruited from patients attending a dental clinic in Antwerp, Belgium. Randomization will be conducted at the time of enrollment using a pre-defined allocation scheme implemented in Microsoft Excel. Treatments will be performed by qualified dental professionals under standardized clinical conditions. Clinical measurements will be collected before intervention and at three months post-intervention by a calibrated examiner.

The trial is designed to provide robust clinical evidence regarding the efficacy and safety of sodium hypochlorite/amino acid gel alone and in combination with cross-linked hyaluronic acid as adjuncts to conventional non-surgical periodontal therapy. Findings may inform future clinical practice and contribute to optimizing non-surgical treatment protocols for periodontitis.

Interventions

• Procedure Standard Non-Surgical Periodontal Therapy
  Standard Non-Surgical Periodontal Therapy based on the American Academy of Periodontology's guidelines: mechanical debridement with manual and ultrasonics
• Procedure tandard Therapy + Sodium Hypochlorite/Amino Acid Gel
  Participants receive the same standard care as Arm 1. In addition, a 0.9% sodium hypochlorite/amino acid gel is instilled into periodontal pockets with probing depth \>4 mm and left for 60 seconds before mechanical debridement. The gel application is repeated as needed until instrumentation is complete.
• Procedure Standard Therapy + Sodium Hypochlorite/Amino Acid Gel + Cross-Linked Hyaluronic Acid
  Participants receive the same treatment as Arm 2. After instrumentation, cross-linked hyaluronic acid gel is applied to the treated pockets to promote healing and tissue regeneration, following the "Clean and Seal" protocol.

Primary outcome measures

• Probing Pocket Depth (PPD) [Time frame: pre-operative and at 3 months post-operative]

Secondary outcome measures (4)

• Plaque index (Silness et Loe) [Time frame: pre-operative and 3 months post-operative]
• Bleeding on probing (BOP) [Time frame: pre-operative and 3 months post-operative]
• gingival recession [Time frame: pre-operative and 3 months post-operative]
• Clinical attachment level [Time frame: Measured at baseline (T0) and 3 months post-treatment (T3).]

Eligibility criteria

Inclusion criteria

• Localized periodontal pocket with a probing depth ≥ 6 mm and a clinical - attachment loss of > 3 mm (periodontitis stage III or IV; classification of the European Federation of Periodontology and American Academy of Periodontology);
• Patients who signed the written informed consent and is willing to cooperate;
• Bleeding on probing in more than 30% of the sites.

Exclusion criteria

• Medical history likely to affect periodontal status and/or to compromise treatment outcomes;
• Patients who received antibiotic and/or anti-inflammatory treatments the last 6 months
• Patients who received immunosuppressors treatments the last 6 months;
• Patients who received any periodontal therapy for the last 6 months;
• Pregnant or lactating women;
• Smokers smoking more than 10 cigarettes per day.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Lebanon · 1 center

• Dental Specialist' DS — Sidon

Publications

• Iorio-Siciliano V, Ramaglia L, Isola G, Blasi A, Salvi GE, Sculean A. Changes in clinical parameters following adjunctive local sodium hypochlorite gel in minimally invasive nonsurgical therapy (MINST) of periodontal pockets: a 6-month randomized controlled clinical trial. Clin Oral Investig. 2021 Sep;25(9):5331-5340. doi: 10.1007/s00784-021-03841-8. Epub 2021 Mar 9. PMID 33687555
• Ramanauskaite E, Machiulskiene Visockiene V, Shirakata Y, Friedmann A, Pereckaite L, Balciunaite A, Dvyliene UM, Vitkauskiene A, Baseviciene N, Sculean A. Microbiological Effects of Sodium Hypochlorite/-Amino Acids and Cross-linked Hyaluronic Acid Adjunctive to Non-surgical Periodontal Treatment. Oral Health Prev Dent. 2024 Apr 30;22:171-180. doi: 10.3290/j.ohpd.b5281925. PMID 38687029
• El Mobadder M, Nammour S, Matys J, Grzech-Lesniak K. Sodium Hypochlorite and Diode Laser in Non-Surgical Treatment of Periodontitis: Clinical and Bacteriological Study with Real Time Polymerase Chain Reaction (PCR). Life (Basel). 2022 Oct 19;12(10):1637. doi: 10.3390/life12101637. PMID 36295072
• Iorio-Siciliano V, Blasi A, Mauriello L, Windisch P, Salvi GE, Sculean A, Ramaglia L. Non-Surgical Submarginal Instrumentation of Peri-Implant Mucositis With Delivery of Sodium Hypochlorite/Amino Acids and Cross-Linked Hyaluronic Acid: A Randomized Clinical Trial. Clin Oral Implants Res. 2026 May;37(5):643-656. doi: 10.1111/clr.70109. Epub 2026 Feb 27. PMID 41761442

Identifiers

NCT: NCT07474272 · MEMLB-NSPT-2026

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗