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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04937023

Enrollment

Registered

2021-06-23

Start date

2021-06-11

Completion date

2022-12-30

Last updated

2021-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Regeneration

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.

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.

Interventions

DRUGUrsodeoxycholic acid gel

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

20 Years to 45 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Evaluation of bone regeneration	Baseline to 6 months	Radiovisiography (RVG) will be used to assess bone regeneration achieved post-operatively after 3 months and 6 months.
Evaluation if clinical attachment level	Baseline to 6 months	Assessment of clinical attachment level (CAL) using UNC-15 probe at baseline and post-operatively at 3 and 6 months.
Evaluation of probing pocket depth	Baseline to 6 months	Assessment of probing pocket (PPD) depth using UNC- 15 probe at baseline and postoperatively at 3 and 6 months.

Secondary

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

Countries

India

Contacts

Primary ContactR V Chandra, MDS;DNB;PhD

viswachandra@hotmail.com9908183071

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026