Comparison of Bone Graft and Photodynamic Therapy in Class II Furcation

July 25, 2024 updated by: Krishnadevaraya College of Dental Sciences & Hospital

Comparative Treatment Evaluation of Human Mandibular Class II Furcation Defects Using Bone Grafts and Antimicrobial Photodynamic Therapy-A Randomized Control Trial.

This is a surgical comparative clinical trial which aims to assess class II buccal furcation defects treated with Xenograft alone or preceded by antimicrobial photodynamic therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

To test the efficacy of photodynamic therapy (Indocyanine green) along with placement of xenograft (Cerabone®-Natural bovine bone grafting material, Botiss biomaterials) to treat a class II furcation defects. The topical study was designed as a randomized controlled, single blinded (patient), split mouth clinical trial with 14 participants. In the control group, the defects were filled with xenograft (Cerabone®) whereas the test group received photodynamic therapy (Indocyanine green) in addition to grafting. Radiovisiography technique was used to observe the possible changes in the furcation region at baseline and 9 months postoperatively.

Study Type

Interventional

Enrollment (Actual)

14

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 Locations

  • India
    • Karnataka
      • Bengaluru, Karnataka, India, 562157
        • Dr. Prabhuji MLV

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

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Systemically healthy subjects Age group of 25-60 years Presence of class II furcation defect on buccal surfaces of mandibular molars as determined by clinical and radiographic evaluation.

Vertical probing depth (VPD) ≥4mm Horizontal probing depth (HPD) ≥4 mm Gingival margin (GM) coronal to or at the level of the roof of the furcation

Exclusion Criteria:

Current and former smokers Administration of antibiotics in the last 6 months History of any periodontal therapy in the past 6 months Known allergic responses to bovine derived graft materials and photosensitizers.

Pregnant and lactating women.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Photodynamic therapy
After debridement photodynamic therapy was performed by applying indocyanine green photo sensitizer to furcation defect sites for 1 min. A diode laser with the wavelength of 810 nm and 100 mW 0f power output in the continuous mode was applied to this site. The indocyanine dye has high absorption in the infrared spectrum with an absorption peak near 810 nm, which is close to the emission of diode lasers. This dye has low toxicity, a rapid elimination time and is a good photo sensitizer. The furcation defects then received the graft hydrated with sterile saline. The graft material compacted into the bone defect was similar to the control site.
Procedure: Open flap debridement and photodynamic therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
percentage of bone fill
Time Frame: 9 months
amount of bone formation
9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical efficacy
Time Frame: 9 months
clinical attachment level
9 months

Collaborators and Investigators

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

Sponsor

Krishnadevaraya College of Dental Sciences & Hospital

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)

April 8, 2016

Primary Completion (Actual)

June 7, 2016

Study Completion (Actual)

May 11, 2017

Study Registration Dates

First Submitted

July 26, 2023

First Submitted That Met QC Criteria

July 19, 2024

First Posted (Actual)

July 25, 2024

Study Record Updates

Last Update Posted (Actual)

July 29, 2024

Last Update Submitted That Met QC Criteria

July 25, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KCDS/185/PG/2015-16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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