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The aim of this study is to evaluate the efficacy of ursodeoxycholic acid as local drug delivery agent in intra- bony defect to achieve bone regeneration.
Experimental: Main treatment group the prepared UDCA gel will be injected using a syringe with blunt cannula into the defect site.
Comparator: In patients allocated to control group, placebo gel will be injected in to the defect site using a syringe with blunt cannula.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UDCA gel will be injected using a syringe with blunt cannula into the defect site | Experimental | In the test group, the prepared UDCA gel will be injected using a syringe with blunt cannula into the two or three wall intra-bony defects with probing pocket depth ≥3mm after performing SRP. |
|
| placebo gel will be injected in to the defect site using a syringe with blunt cannula. | Placebo Comparator | In patients allocated to control group, placebo gel will be injected in to the defect site using a syringe with blunt cannula after scaling and root planing. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ursodeoxycholic acid gel | Drug | Following scaling and root planing in intrabony defects UDCA gel will be injected |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of bone regeneration | Radiovisiography (RVG) will be used to assess bone regeneration achieved post-operatively after 3 months and 6 months. | Baseline to 6 months |
| Evaluation if clinical attachment level | Assessment of clinical attachment level (CAL) using UNC-15 probe at baseline and post-operatively at 3 and 6 months. | Baseline to 6 months |
| Evaluation of probing pocket depth | Assessment of probing pocket (PPD) depth using UNC- 15 probe at baseline and postoperatively at 3 and 6 months. | Baseline to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of gingiva | Gingival index (GI) - according to Loe H and Silness P, 1963 | Baseline to 6 months |
| Evaluation of gingival bleeding | Gingival bleeding index - Ainamo and Bay, 1975 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| R V Chandra, MDS;DNB;PhD | Contact | 9908183071 | viswachandra@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SVS Institute of Dental Sciences | Recruiting | Hyderabad | Telangana | 509002 | India |
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| Baseline to 6 months |