Assessing the Clinical Efficacy of Bentonite Clay Gel on Bone Regeneration in the Treatment of Intra-bony Defects: A Clinico-radiograph Study

Not Applicable

Recruiting

• Conditions: Bone Regeneration
• Interventions: Other: bentonite clay gel with hydroxyapatite

• Registration Number: NCT06439264
• Lead Sponsor: Dr R Viswa Chandra

Brief Summary

The aim of this study is to evaluate osseous regeneration efficacy of bentonite gel with hydroxyapatite in comparison with hydroxyapatite incase of intrabony defects

The test group includes patients with intrabony defects where flap surgery is will be performed and bentonite clay gel with HA will be placed and in control group only HA is placed.

Detailed Description

Experimental: Main treatment group bentonite with hydroxyaatite is added into the defect site.

Comparator: In patients allocated to control group,only hydroxyapatite is added.

Study Timeline

• Study Start: 2023-05-03
• Status Verified: 2024-05
• Primary Completion: 2024-05
• Study Completion: 2024-05
• Study First Submitted: 2024-05-17
• Study First Submitted QC: 2024-05-31
• Last Update Submitted: 2024-05-31
• Study First Posted: 2024-06-03
• Last Update Posted: 2024-06-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1. Systemically healthy male and female patients of age >18 years
2. two-walled or three-walled intrabony defects and
3. probing pocket depths (PPD) of ≥ 5mm.

Exclusion Criteria

1. Medically compromised patients,
2. patients <18 years of age,
3. pregnant women,
4. heavy smokers, and
5. patients who underwent radiotherapy or chemotherapy are excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	bentonite clay gel with hydroxyapatite	In control group, after reflection of flap and degranulation, bone graft i.e., hydroxyapatite will be placed in the defect and sutures will be placed.
test group	bentonite clay gel with hydroxyapatite	In test group, after reflection of flap and degranulation, bone graft i.e., bentonite clay gel with hydroxyapatite will be placed in the void created by the defect and sutures will be placed

Primary Outcome Measures

Name	Time	Method
RVG	baseline , 3months,6months	1. Radiovisiography will be used to assess bone regeneration achieved post operatively after 3 months and 6 months.
clinical attachment level	baseline , 3months,6months	Assessment of clinical attachment level using probe at baseline and post operatively at 3 and 6 months.
probing depth	baseline , 3months,6months	2. Assessment of probing depth using probe at baseline and postoperatively at 3 and 6 months

Secondary Outcome Measures

Name	Time	Method
1. Assessment of plaque - according to Turesky modification of Quigley and Hein Plaque Index, 1970. 2. Assessment of Gingivitis - according to Loe H and Silness P, 1963.	baseline ,3months,6months	1. Assessment of plaque - according to Turesky modification of Quigley and Hein Plaque Index, 1970.; 2. Assessment of Gingivitis - according to Loe H and Silness P, 1963.

Trial Locations

Locations (1)

Svs Dental College; 🇮🇳 Mahbūbnagar, Telangana, India