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NCT Number: NCT07474272

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

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

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Key information

Conditions

Periodontitis Mouth Diseases Periodontal Diseases Periodontal Pocket Stomatognathic Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Standard Non-Surgical Periodontal Therapy

Procedure

Standard Non-Surgical Periodontal Therapy based on the American Academy of Periodontology's guidelines: mechanical debridement with manual and ultrasonics

tandard Therapy + Sodium Hypochlorite/Amino Acid Gel

Procedure

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.

Standard Therapy + Sodium Hypochlorite/Amino Acid Gel + Cross-Linked Hyaluronic Acid

Procedure

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 outcomes

  1. 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.

Secondary outcomes

  1. 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.

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

  2. 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.

  3. 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.

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Marwan El Mobadder, doctor (Ph.D)

CONTACT

[email protected]

+33658940326

Sponsors and collaborators

Lead sponsor

Marwan El Mobadder

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 16, 2026
Registry last updated
Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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