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
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.
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;
Parallel
Standard Non-Surgical Periodontal Therapy
Procedure/SurgeryStandard 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/SurgeryParticipants 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/SurgeryParticipants 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.
Probing Pocket Depth (PPD)
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.
Plaque index (Silness et Loe)
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)
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
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
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.
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Marwan El Mobadder
Lead sponsor
El Mobadder, Marwan, Ph.D., DDS
Sponsor institution
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