NCT07474272

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 78 (estimated)
• Sponsor: Marwan El Mobadder · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Periodontitis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-03-11
• Primary completion: 2026-06-30
• Completion: 2026-08-01
• First posted: 2026-03-16
• Last updated: 2026-03-17

Locations

1 site across 1 country: Lebanon