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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Bone Regeneration
• Intervention / Treatment: Drug: Ursodeoxycholic acid gel

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 Type: Interventional
• Enrollment (Anticipated): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Telangana
    • Hyderabad, Telangana, India, 509002
      • Recruiting
      • SVS Institute of Dental Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: UDCA gel will be injected using a syringe with blunt cannula into the defect site; 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; Following scaling and root planing in intrabony defects UDCA gel will be injected; Other Names: experimental group
PLACEBO_COMPARATOR: placebo gel will be injected in to the defect site using a syringe with blunt cannula.; 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; Following scaling and root planing in intrabony defects UDCA gel will be injected; Other Names: experimental group

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: SVS Institute of Dental Sciences

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 11, 2021
• Primary Completion (ANTICIPATED): December 31, 2021
• Study Completion (ANTICIPATED): December 30, 2022

Study Registration Dates

• First Submitted: June 17, 2021
• First Submitted That Met QC Criteria: June 17, 2021
• First Posted (ACTUAL): June 23, 2021

Study Record Updates

• Last Update Posted (ACTUAL): June 23, 2021
• Last Update Submitted That Met QC Criteria: June 17, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Gastrointestinal Agents; Cholagogues and Choleretics; Ursodeoxycholic Acid
• Other Study ID Numbers: SVSIDS/PERIO/1/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No