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

NCT04937023 | Unknown

• 1 other identifier: SVSIDS/PERIO/1/2020
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Bone Regeneration

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Evaluation of gingiva

  Baseline to 6 months

• Evaluation of gingival bleeding

  Baseline to 6 months

Study Arms (2)

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.

Drug: Ursodeoxycholic acid gel

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.

Drug: Ursodeoxycholic acid gel

Interventions

Ursodeoxycholic acid gel DRUG

Following scaling and root planing in intrabony defects UDCA gel will be injected

Also known as: experimental group

UDCA gel will be injected using a syringe with blunt cannula into the defect site; placebo gel will be injected in to the defect site using a syringe with blunt cannula.

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Medically compromised patients, pregnant women, heavy smokers, and patients who underwent radiotherapy or chemotherapy will be excluded.

Sponsors & Collaborators

• SVS Institute of Dental Sciences: lead

Study Sites (1)

SVS Institute of Dental Sciences

Hyderabad, Telangana, 509002, India

RECRUITING

Central Study Contacts

R V Chandra, MDS;DNB;PhD

CONTACT

9908183071; viswachandra@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: June 17, 2021
• First Posted: June 23, 2021
• Study Start: June 11, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 30, 2022
• Last Updated: June 23, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)