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

NCT ID: NCT06439264

Last Updated: 2024-06-03

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

RECRUITING

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-03

Study Completion Date

2024-05-31

Brief Summary

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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

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

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

Conditions

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Bone Regeneration

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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test group

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

Group Type EXPERIMENTAL

bentonite clay gel with hydroxyapatite

Intervention Type 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

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.

Group Type ACTIVE_COMPARATOR

bentonite clay gel with hydroxyapatite

Intervention Type 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,

Interventions

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bentonite clay gel with hydroxyapatite

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,

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dr R Viswa Chandra

OTHER

Sponsor Role lead

Responsible Party

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Dr R Viswa Chandra

PROFFESSOR AND HEAD OF THE DEPARTMENT

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Svs Dental College

Mahbūbnagar, Telangana, India

Site Status RECRUITING

Countries

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India

Central Contacts

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Dr.viswa chandra MDS

Role: CONTACT

9912161007

Facility Contacts

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VISWA CHANDRA PROFESSOR

Role: primary

9908183071

Other Identifiers

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SVSInstituteDS

Identifier Type: -

Identifier Source: org_study_id

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