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

SVS Institute of Dental Sciences

Status: Unknown

Conditions: Bone Regeneration

Treatments: Drug: Ursodeoxycholic acid gel

Study type: Interventional

Funder types: Other

Identifiers

NCT04937023

SVSIDS/PERIO/1/2020

Details and patient eligibility

About

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.

Full 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.

Enrollment: 26 estimated patients

Sex: All

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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26 participants in 2 patient groups, including a placebo group

UDCA gel will be injected using a syringe with blunt cannula into the defect site

Experimental group

Description:

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.

Treatment:

Drug: Ursodeoxycholic acid gel

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

Placebo Comparator group

Description:

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.

Treatment:

Drug: Ursodeoxycholic acid gel