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

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.

• 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

• Probing Pocket Depth (PPD) [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

• Plaque index (Silness et Loe) [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.
• Bleeding on probing (BOP) [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.
• gingival recession [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.
• Clinical attachment level [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.

Sex: All, ages: 16 Years to any

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.

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