Efficacy of Insulin Like Growth Factor-1(IGF-1) on Bone Regeneration in Intrabony Defects : A Clinico-radiograph Study

NCT06426524 | Recruiting DMC

• 1 other identifier: SVSInstituteDS1
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to clinically evaluate the efficacy of Insulin like Growth Factor (IGF-1) on bone regeneration in intrabony defects.

Conditions

Intrabony Periodontal Defect

Outcome Measures

Primary Outcomes (3)

• Bone Regeneration

  Radiovisiography (RVG) will be used to assess bone regeneration achieved post operatively after 3 months and 6 months.

  3 months and 6 months

• clinical attachment level

  Assessment of clinical attachment level using UNC-15 probe at baseline and post operatively at 3 and 6 months.

  3 months and 6 months

• Probig depth

  Assessment of probing depth using UNC-15 probe at baseline and postoperatively at 3 and 6 months.

  3 months and 6 months

Secondary Outcomes (1)

• Plaque Index

  3 months and 6 months

Study Arms (2)

Test group

EXPERIMENTAL

In test group, after reflection of flap and degranulation, IGF-1 gel with hydroxyapatite will be placed in the defect and sutures will be placed.

Procedure: IGF-1 Gel

Control group

ACTIVE COMPARATOR

In control group, after reflection of flap and degranulation, hydroxyapatite will be placed in the defect and sutures will be placed.

Procedure: Hydroxyapatite

Interventions

IGF-1 Gel PROCEDURE

After degranulation of the defect, IGF-1 gel mixed with Hydroxyapatite graft will be placed in the defect.

Test group

Hydroxyapatite PROCEDURE

After degranulation of the defect, Hydroxyapatite graft will be placed in the defect.

Control 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 Intrabony defects - two wall or three wall defects Probing pocket depths (PPD) of \>5mm.

You may not qualify if:

• Medically compromised patients Pregnant women Heavy smokers Patients who underwent radiotherapy or chemotherapy are excluded

Sponsors & Collaborators

• Dr R Viswa Chandra: lead

Study Sites (1)

SVS Institute of Dental Sciences, Mahabubnagar

Hyderabad, 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 R Viswa Chandra, MDS;DNB;PhD

CONTACT

8179367147; 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: May 23, 2024
• Study Start: May 19, 2023
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: May 23, 2024

Record last verified: 2024-05

Locations

IN (1)