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This randomized controlled clinical trial aims to evaluate the effectiveness of using nano-hydroxyapatite (nHA) gel alongside a minimally invasive non-surgical technique (MINST) to treat deep intra-bony defects in patients with Stage III periodontitis. While MINST is an effective method for cleaning deep periodontal pockets without the need for traditional surgery, the addition of nHA may further enhance soft tissue healing, improve cellular interaction, and promote bone 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 nHA gel directly 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 nHA provides superior clinical 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-hydroxyapatite | Experimental | Participants receive MINST combined with the adjunctive application of nano-hydroxyapatite gel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Minimally invasive non-surgical technique (MINST) | Procedure | Subgingival debridement using thin ultrasonic tips and Gracey mini-curettes under magnification, deliberately avoiding subgingival rinsing to support blood clot stabilization |
| Measure | Description | Time Frame |
|---|---|---|
| Probing Pocket Depth (PPD) | Measured in millimeters (mm) using a manual periodontal probe (UNC-15) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Full-Mouth Plaque Score (FMPS) | Assessed as a percentage (%) using the Visible Plaque Index (O'Leary et al.). The index ranges from a minimum of 0% to a maximum of 100%. Higher percentages indicate a greater presence of plaque, representing a worse clinical outcome. | 1, 3, and 6 months post-treatment. |
| Full-Mouth Bleeding Score (FMBS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oral Medicine and Periodontology department, Faculty of Dentistry - Cairo University. | Cairo | 11511 | Egypt |
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| nano-hydroxyapatite | Biological | A single dose of nano-hydroxyapatite (nHA) gel applied subgingivally directly into the periodontal pocket associated with the intrabony defect immediately following debridement |
|
Assessed as a percentage (%) using the Gingival Bleeding Index (Ainamo & Bay). The index ranges from a minimum of 0% to a maximum of 100%. Higher percentages indicate more widespread gingival bleeding, representing a worse clinical outcome. |
| 1, 3, and 6 months post-treatment. |
| Clinical Attachment Level (CAL) | Measured in millimeters (mm) using a manual periodontal probe (UNC-15). | 1, 3, and 6 months post-treatment. |
| Gingival Recession (GR) | Measured in millimeters (mm) using a manual periodontal probe (UNC-15). | 1, 3, and 6 months post-treatment. |
| Radiographic Defect Angle (RDA) | Measured in degrees (°) utilizing standardized periapical radiographs and measurement software. | 1, 3, and 6 months post-treatment. |
| Patient Satisfaction | Assessed via a structured questionnaire utilizing a Likert scale. The scale ranges from 1 to 5, where 1 indicates "Very Dissatisfied" and 5 indicates "Very Satisfied," meaning higher scores represent a better outcome. | 1, 3, and 6 months post-treatment. |
| Cost Effectiveness based on Clinical Attachment Level (CAL) | Evaluated using the cost-effectiveness ratio (CER) and incremental cost-effectiveness ratio (ICER), based on the cost in USD per millimeter (mm) of CAL improvement. | 6 months post-treatment. |
| Cost Effectiveness based on Probing Pocket Depth (PPD) | Evaluated using the cost-effectiveness ratio (CER) and incremental cost-effectiveness ratio (ICER), based on the cost in USD per millimeter (mm) of PPD improvement. | 6 months post-treatment. |
| ID | Term |
|---|---|
| D010518 | Periodontitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| C509317 | nano-hydroxyapatite-collagen |
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