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

NCT06439264 | Recruiting DMC

• 1 other identifier: SVSInstituteDS
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Bone Regeneration

Outcome Measures

Primary Outcomes (3)

• RVG

  1\. Radiovisiography will be used to assess bone regeneration achieved post operatively after 3 months and 6 months.

  baseline , 3months,6months

• probing depth

  2\. Assessment of probing depth using probe at baseline and postoperatively at 3 and 6 months

  baseline , 3months,6months

• clinical attachment level

  Assessment of clinical attachment level using probe at baseline and post operatively at 3 and 6 months.

  baseline , 3months,6months

Secondary Outcomes (1)

• 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

Study Arms (2)

test group

EXPERIMENTAL

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

Other: bentonite clay gel with hydroxyapatite

control group

ACTIVE COMPARATOR

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.

Other: bentonite clay gel with hydroxyapatite

Interventions

bentonite clay gel with hydroxyapatite OTHER

bentonite clay gel presents great potential for bone healing and it leads to the formation of interconnected microporous structure, which can promote native cell infiltration, proliferation,

control group; test group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Medically compromised patients,
• patients \<18 years of age,
• pregnant women,
• heavy smokers, and
• patients who underwent radiotherapy or chemotherapy are excluded.

Sponsors & Collaborators

• Dr R Viswa Chandra: lead

Study Sites (1)

Svs Dental College

Mahbūbnagar, Telangana, 509002, India

RECRUITING

MeSH Terms

Interventions

Durapatite

Intervention Hierarchy (Ancestors)

Hydroxyapatites; Apatites; Calcium Phosphates; Phosphates; Phosphoric Acids; Phosphorus Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Calcium Compounds; Minerals; Phosphorus Compounds

Central Study Contacts

Dr.viswa chandra MDS

CONTACT

9912161007; viswachandra@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PROFFESSOR AND HEAD OF THE DEPARTMENT

Study Record Dates

• First Submitted: May 17, 2024
• First Posted: June 3, 2024
• Study Start: May 3, 2023
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: June 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)