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

Bone Regeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04937023
• Other study ID #: SVSIDS/PERIO/1/2020
• Status: Recruiting
• Phase: N/A
• Start date: June 11, 2021
• Est. completion date: December 30, 2022

Study information

• Verified date: June 2021
• Source: SVS Institute of Dental Sciences
• Contact: R V Chandra, MDS;DNB;PhD
• Phone: 9908183071
• Email: viswachandra[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 26
• Est. completion date: December 30, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bone Regeneration

Intervention

Drug:
• Ursodeoxycholic acid gel
Following scaling and root planing in intrabony defects UDCA gel will be injected

Locations

Country	Name	City	State
India	SVS Institute of Dental Sciences	Hyderabad	Telangana

Sponsors (1)

Lead Sponsor	Collaborator
SVS Institute of Dental Sciences

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Evaluation of gingiva	Gingival index (GI) - according to Loe H and Silness P, 1963	Baseline to 6 months
Secondary	Evaluation of gingival bleeding	Gingival bleeding index - Ainamo and Bay, 1975	Baseline to 6 months