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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-11

Study Completion Date

2022-12-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Bone Regeneration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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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.

Group Type EXPERIMENTAL

Ursodeoxycholic acid gel

Intervention Type DRUG

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

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.

Group Type PLACEBO_COMPARATOR

Ursodeoxycholic acid gel

Intervention Type DRUG

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

Interventions

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Ursodeoxycholic acid gel

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

Intervention Type DRUG

Other Intervention Names

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experimental group

Eligibility Criteria

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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