Periodontitis
Conditions
Keywords
periodontal pocket, periodontitis, periodontal disease, deep periodontal pocket, localized periodontitis, generalized periodontitis, non-surgical treatment of periodontitis, non-surgical periodontal treatment
Brief summary
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
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.
Interventions
PROCEDUREStandard Non-Surgical Periodontal Therapy
Standard Non-Surgical Periodontal Therapy based on the American Academy of Periodontology's guidelines: mechanical debridement with manual and ultrasonics
PROCEDUREtandard 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.
PROCEDUREStandard 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.
Sponsors
Marwan El Mobadder
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Not applicable; all procedures are open-label.
Intervention model description
The trial has three parallel arms: standard care, standard care plus sodium hypochlorite/amino acid gel, and standard care plus sodium hypochlorite/amino acid gel + cross-linked hyaluronic acid ("Clean and Seal" protocol). Participants remain in their assigned group for the duration of the study.
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Lebanon
Contacts
CONTACTMarwan El Mobadder, doctor (Ph.D)
STUDY_DIRECTORMarwan El Mobadder, Doctor Ph.D
Department of Periodontology, Faculty of dental medicine, Lebanese University
STUDY_CHAIRKinga Grzech-Lesiniak, Ph.D (doctor)
Dental Surgery Department, Wroclaw Medical University
Outcome results
None listed