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

Not Applicable

• Conditions: Bone Regeneration
• Interventions: Drug: Ursodeoxycholic acid gel

• Registration Number: NCT04937023
• Lead Sponsor: SVS Institute of Dental Sciences

Brief Summary

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

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.

Study Timeline

• Status Verified: 2021-06
• Study Start: 2021-06-11
• Study First Submitted: 2021-06-17
• Study First Submitted QC: 2021-06-17
• Last Update Submitted: 2021-06-17
• Study First Posted: 2021-06-23
• Last Update Posted: 2021-06-23
• Primary Completion: 2021-12-31
• Study Completion: 2022-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 26

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo gel will be injected in to the defect site using a syringe with blunt cannula.	Ursodeoxycholic acid gel	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.
UDCA gel will be injected using a syringe with blunt cannula into the defect site	Ursodeoxycholic acid gel	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.

Primary Outcome Measures

Name	Time	Method
Evaluation if clinical attachment level	Baseline to 6 months	Assessment of clinical attachment level (CAL) using UNC-15 probe at baseline and post-operatively at 3 and 6 months.
Evaluation of bone regeneration	Baseline to 6 months	Radiovisiography (RVG) will be used to assess bone regeneration achieved post-operatively after 3 months and 6 months.
Evaluation of probing pocket depth	Baseline to 6 months	Assessment of probing pocket (PPD) depth using UNC- 15 probe at baseline and postoperatively at 3 and 6 months.

Secondary Outcome Measures

Name	Time	Method
Evaluation of gingival bleeding	Baseline to 6 months	Gingival bleeding index - Ainamo and Bay, 1975
Evaluation of gingiva	Baseline to 6 months	Gingival index (GI) - according to Loe H and Silness P, 1963

Trial Locations

Locations (1)

SVS Institute of Dental Sciences; 🇮🇳 Hyderabad, Telangana, India