Comparison of Bone Graft and Photodynamic Therapy in Class II Furcation

NCT ID: NCT06519409

Last Updated: 2024-07-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-08
• Study Completion Date: 2017-05-11

Brief Summary

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.

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.

Conditions

Furcation Defects

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Open flap debridement and photodynamic therapy

Intervention Type: PROCEDURE

Interventions

Open flap debridement and photodynamic therapy

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Krishnadevaraya College of Dental Sciences & Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Dr. Prabhuji MLV

Bengaluru, Karnataka, India

Countries

India

Other Identifiers

KCDS/185/PG/2015-16

Identifier Type: -

Identifier Source: org_study_id