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Completed

NCT Number: NCT06519409

Comparison of Bone Graft and Photodynamic Therapy in Class II Furcation

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.

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Key information

Conditions

Furcation Defects Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

25 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr. Prabhuji MLV

Bengaluru, Karnataka, 562157, India

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Open flap debridement and photodynamic therapy

Procedure

Primary outcomes

  1. percentage of bone fill

    Time frame: 9 months

    amount of bone formation

Secondary outcomes

  1. Clinical efficacy

    Time frame: 9 months

    clinical attachment level

Sponsors and collaborators

Lead sponsor

Krishnadevaraya College of Dental Sciences & Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Jul 25, 2024
Registry last updated
Jul 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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