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

May 31, 2024 updated by: Dr R Viswa Chandra

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • India
    • Telangana
      • Mahbūbnagar, Telangana, India, 509002
        • Recruiting
        • Svs Dental College
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Other: 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,
Active Comparator: 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.
Other: 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,

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 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.
baseline ,3months,6months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr R Viswa Chandra

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 3, 2023

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

May 1, 2024

Study Registration Dates

First Submitted

May 17, 2024

First Submitted That Met QC Criteria

May 31, 2024

First Posted (Actual)

June 3, 2024

Study Record Updates

Last Update Posted (Actual)

June 3, 2024

Last Update Submitted That Met QC Criteria

May 31, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SVSInstituteDS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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