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

May 17, 2024 updated by: Dr R Viswa Chandra
The aim of this study is to clinically evaluate the efficacy of Insulin like Growth Factor (IGF-1) on bone regeneration in intrabony defects.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

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

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
      • Hyderabad, Telangana, India, 509002
        • Recruiting
        • SVS Institute of Dental Sciences, Mahabubnagar
        • 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:

Systemically healthy male and female patients of age >18 years Intrabony defects - two wall or three wall defects Probing pocket depths (PPD) of >5mm.

Exclusion Criteria:

Medically compromised patients Pregnant women Heavy smokers 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, IGF-1 gel with hydroxyapatite will be placed in the defect and sutures will be placed.
Procedure: IGF-1 Gel
After degranulation of the defect, IGF-1 gel mixed with Hydroxyapatite graft will be placed in the defect.
Active Comparator: Control group
In control group, after reflection of flap and degranulation, hydroxyapatite will be placed in the defect and sutures will be placed.
Procedure: Hydroxyapatite
After degranulation of the defect, Hydroxyapatite graft will be placed in the defect.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone Regeneration
Time Frame: 3 months and 6 months
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
Time Frame: 3 months and 6 months
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
Time Frame: 3 months and 6 months
Assessment of probing depth using UNC-15 probe at baseline and postoperatively at 3 and 6 months.
3 months and 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plaque Index
Time Frame: 3 months and 6 months
Assessment of plaque (PI) - according to Turesky modification of Quigley and Hein Plaque Index, 1970.
3 months and 6 months

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 19, 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 17, 2024

First Posted (Actual)

May 23, 2024

Study Record Updates

Last Update Posted (Actual)

May 23, 2024

Last Update Submitted That Met QC Criteria

May 17, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • SVSInstituteDS1

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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