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

March 14, 2026 updated by: Marwan El Mobadder

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

78

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Lebanon
    • South of Lebanon
      • Sidon, South of Lebanon, Lebanon
        • Dental Specialist' DS
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control group
Participants receive standard care, including oral hygiene instructions, supragingival and subgingival mechanical debridement using ultrasonic and hand instruments, and brief irrigation with 0.12% chlorhexidine solution. No adjunctive sodium hypochlorite or hyaluronic acid is used.
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
Experimental: Standard 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 (Perisolv) 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: 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.
Experimental: 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 (Hyadent BG) is applied to the treated pockets to promote healing and tissue regeneration, following the "Clean and Seal" protocol.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Probing Pocket Depth (PPD)
Time Frame: pre-operative and at 3 months post-operative
Probing Pocket Depth is the distance, measured in millimeters, from the gingival margin (the edge of the gum tissue) to the bottom of the periodontal pocket, which is the point where the soft tissue attaches to the tooth. It is measured using a calibrated periodontal probe at six sites per tooth: mesiobuccal, mid-buccal, distobuccal, mesiolingual/palatal, mid-lingual/palatal, and distolingual/palatal.
pre-operative and at 3 months post-operative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plaque index (Silness et Loe)
Time Frame: pre-operative and 3 months post-operative

The Plaque Index is a clinical measure of dental plaque accumulation on the surfaces of teeth. Each selected tooth surface is scored from 0 to 3 based on the thickness and visibility of plaque:

0: No plaque.

  1. A thin film of plaque adhering to the free gingival margin and adjacent tooth surface, only visible after running a probe across the surface.
  2. Moderate accumulation of plaque within the gingival pocket or on the tooth surface, visible to the naked eye.
  3. Abundant plaque accumulation within the gingival pocket and/or on the tooth and gingival margin.

In this study, PI will be recorded on four surfaces (mesial, distal, buccal, and lingual) of selected teeth (#16, #12, #24, #36, #32, #44). Scores for each tooth are summed and divided by the number of surfaces examined to obtain the mean PI, which reflects overall oral hygiene status.
pre-operative and 3 months post-operative
Bleeding on probing (BOP)
Time Frame: pre-operative and 3 months post-operative

Bleeding on Probing is a clinical measure of gingival inflammation. A periodontal probe is gently inserted into the gingival sulcus or periodontal pocket at six sites per tooth (mesiobuccal, mid-buccal, distobuccal, mesiolingual/palatal, mid-lingual/palatal, distolingual/palatal).

Scoring: Each site is recorded as positive if bleeding occurs within 15 seconds after probing, and negative if no bleeding occurs.

The percentage of bleeding sites is calculated for each participant.

Timepoints: Measured at baseline (T0) and 3 months post-treatment (T3) to assess changes in gingival inflammation following therapy.
pre-operative and 3 months post-operative
gingival recession
Time Frame: pre-operative and 3 months post-operative

Gingival Recession is the distance, in millimeters, from the cementoenamel junction (CEJ) to the free gingival margin.

Measurement: Taken at six sites per tooth using a calibrated periodontal probe.

Interpretation: A positive value indicates that the gingival margin is apical (toward the root) relative to the CEJ.

Gingival recession reflects loss of soft tissue coverage and is often associated with periodontal disease progression.
pre-operative and 3 months post-operative
Clinical attachment level
Time Frame: Measured at baseline (T0) and 3 months post-treatment (T3).

Clinical Attachment Level is a measure of periodontal tissue support and combines pocket depth and gingival recession.

Measurement: CAL is calculated as:

If gingival margin is at the CEJ: CAL = Probing Pocket Depth (PPD)

If gingival margin is apical to CEJ (recession): CAL = PPD + GR

If gingival margin is coronal to CEJ: CAL = PPD - distance from CEJ to gingival margin

Significance: CAL reflects the true attachment loss and is a key parameter for diagnosing and monitoring periodontitis.
Measured at baseline (T0) and 3 months post-treatment (T3).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marwan El Mobadder

Investigators

  • Study Director: Marwan El Mobadder, Doctor Ph.D, Department of Periodontology, Faculty of dental medicine, Lebanese University
  • Study Chair: Kinga Grzech-Lesiniak, Ph.D (doctor), Dental Surgery Department, Wroclaw Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 11, 2026

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

March 11, 2026

First Submitted That Met QC Criteria

March 11, 2026

First Posted (Actual)

March 16, 2026

Study Record Updates

Last Update Posted (Actual)

March 17, 2026

Last Update Submitted That Met QC Criteria

March 14, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEMLB-NSPT-2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) from this study will not be shared due to the small sample size and the sensitive nature of patient-level clinical measurements. Sharing such data could risk participant confidentiality and privacy. Additionally, the study is investigator-initiated, and resources for secure anonymization, storage, and controlled access for external researchers are not available at this time.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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