An interventional study of Standard Non-Surgical Periodontal Therapy and tandard Therapy + Sodium Hypochlorite/Amino Acid Gel in Periodontitis, sponsored by Marwan El Mobadder. Not yet recruiting at 1 site in Lebanon. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2026-03-17.
Sponsored by Marwan El Mobadder · Not applicable, Interventional, and Treatment
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
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.
1,231 studies on the registry are indexed under Periodontitis; 295 are open to participants now.
This study's planned enrollment of 78 is above the median of 44 across 846 interventional studies indexed under Periodontitis.
Browse Periodontitis studies →This is the only study on the registry with Marwan El Mobadder as lead sponsor.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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 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
Standard Non-Surgical Periodontal Therapy based on the American Academy of Periodontology's guidelines: mechanical debridement with manual and ultrasonics
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.
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.
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.
Time frame: pre-operative and at 3 months post-operative
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.
Time frame: pre-operative and 3 months post-operative
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.
Time frame: pre-operative and 3 months post-operative
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.
Time frame: pre-operative and 3 months post-operative
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.
Time frame: Measured at baseline (T0) and 3 months post-treatment (T3).
Plan to share: No — 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.
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