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This randomized controlled clinical trial aims to evaluate the effectiveness of using nano-hyaluronic acid (nano-HyA) gel alongside a minimally invasive non-surgical technique (MINST) to treat deep intrabony defects in patients with Stage II and III periodontitis. While MINST is a proven method for cleaning deep periodontal pockets without the need for traditional surgery , the addition of nano-HyA may further enhance soft tissue healing, reduce inflammation, and promote regeneration. Participants in the study will be randomly assigned to one of two groups. The test group will receive the MINST procedure combined with the application of nano-HyA gel into the periodontal pocket, while the control group will receive the MINST procedure alone. The primary goal of the study is to measure the decrease in probing pocket depth over a 6-month follow-up period to determine if the adjunctive use of nano-HyA provides superior clinical and radiographic outcomes compared to non-surgical treatment alone
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MINST alone | Active Comparator | Participants receive the minimally invasive non-surgical technique (MINST) alone without adjunctive treatment |
|
| MINST + nano-hyaluronic acid | Experimental | Participants receive MINST combined with adjunctive nano-hyaluronic acid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Minimally invasive non-surgical technique (MINST) | Procedure | Subgingival debridement using thin ultrasonic tips and additional instrumentation with Gracey mini-curettes, deliberately avoiding subgingival rinsing to support blood clot stabilization |
| Measure | Description | Time Frame |
|---|---|---|
| Pocket Depth (PD) | Measured in millimeters (mm) from the gingival margin to the bottom of the gingival sulcus using a UNC-15 periodontal probe. Each tooth is probed at 6 sites with a light force not exceeding 25 grams. | "From enrollment to the end of treatment at 24 weeks" |
| Measure | Description | Time Frame |
|---|---|---|
| Full-Mouth Plaque Score (FMPS) | Assessed as the percentage of sites with plaque. | From enrollment to the end of treatment at 24 weeks |
| Full-Mouth Bleeding Score (FMBS) | Assessed as the percentage of sites with bleeding upon probing. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry, Cairo University | Cairo | Cairo Governorate | Egypt |
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| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D010518 | Periodontitis |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| nano-hyaluronic acid | Biological | Pockets associated with intrabony defects are filled with nano-HyA paste immediately after subgingival debridement |
|
| From enrollment to the end of treatment at 24 weeks |
| Clinical Attachment Level (CAL) | Measured in millimeters (mm) from the cemento-enamel junction to the bottom of the pocket. | From enrollment to the end of treatment at 24 weeks |
| Gingival Recession (GR) | Measured in millimeters (mm) from the cemento-enamel junction to the gingival margin. | From enrollment to the end of treatment at 24 weeks |
| Radiographic Defect Angle (RDA) | Measured in degrees (°). | From enrollment to the end of treatment at 24 weeks |
| Patient Satisfaction | Assessed via a Likert-scale questionnaire. The scale ranges from 1 to 5, where 1 indicates "Very Dissatisfied" and 5 indicates "Very Satisfied". Higher scores represent a better outcome. | From enrollment to the end of treatment at 24 weeks |
| Cost Effectiveness | Evaluated through a health economic analysis, measured as currency per unit effect. | From enrollment to the end of treatment at 24 weeks |