Ursodeoxycholic Acid (Udca) as a Local Drug Delivery Agent in the Treatment of Intra-bony Defects

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Assessing the Clinical Efficacy of Ursodeoxycholic Acid (Udca) as a Local Drug Delivery Agent in the Treatment of Intra-bony Defects: A Clinico-radiographic Study

Conditions
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Bone Regeneration

Intervention / Treatment
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* Drug: Ursodeoxycholic acid gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Systemically healthy male and female patients of age>18 years with intrabony defects - two wall or three wall defects and probing pocket depths (PPD) of >3mm will be included Exclusion Criteria: Medically compromised patients, pregnant women, heavy smokers, and patients who underwent radiotherapy or chemotherapy will be excluded.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: UDCA gel will be injected using a syringe with blunt cannula into the defect site<br>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. | Drug: Ursodeoxycholic acid gel<br>* Following scaling and root planing in intrabony defects UDCA gel will be injected<br>* Other names: experimental group;|
| Placebo Comparator: placebo gel will be injected in to the defect site using a syringe with blunt cannula.<br>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. | Drug: Ursodeoxycholic acid gel<br>* Following scaling and root planing in intrabony defects UDCA gel will be injected<br>* Other names: experimental group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | Baseline to 6 months |