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

Bone Regeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06439264
• Other study ID #: SVSInstituteDS
• Status: Recruiting
• Phase: N/A
• Start date: May 3, 2023
• Est. completion date: May 2024

Study information

• Verified date: May 2024
• Source: SVS Institute of Dental Sciences
• Contact: Dr.viswa chandra MDS
• Phone: 9912161007
• Email: viswachandra[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bone Regeneration

Intervention

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,

Locations

Country	Name	City	State
India	Svs Dental College	Mahbubnagar	Telangana

Sponsors (1)

Lead Sponsor	Collaborator
Dr R Viswa Chandra

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	RVG	1. Radiovisiography will be used to assess bone regeneration achieved post operatively after 3 months and 6 months.	baseline , 3months,6months
Primary	probing depth	2. Assessment of probing depth using probe at baseline and postoperatively at 3 and 6 months	baseline , 3months,6months
Primary	clinical attachment level	Assessment of clinical attachment level using probe at baseline and post operatively at 3 and 6 months.	baseline , 3months,6months
Secondary	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.	Assessment of plaque - according to Turesky modification of Quigley and Hein Plaque Index, 1970.; Assessment of Gingivitis - according to Loe H and Silness P, 1963.	baseline ,3months,6months