Comparison of Bone Graft and Photodynamic Therapy in Class II Furcation
Comparative Treatment Evaluation of Human Mandibular Class II Furcation Defects Using Bone Grafts and Antimicrobial Photodynamic Therapy-A Randomized Control Trial.
1 other identifier
interventional
14
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 8, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 7, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 11, 2017
CompletedFirst Submitted
Initial submission to the registry
July 26, 2023
CompletedFirst Posted
Study publicly available on registry
July 25, 2024
CompletedJuly 29, 2024
July 1, 2024
2 months
July 26, 2023
July 25, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
percentage of bone fill
amount of bone formation
9 months
Secondary Outcomes (1)
Clinical efficacy
9 months
Study Arms (1)
Photodynamic therapy
EXPERIMENTALAfter 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dr. Prabhuji MLV
Bengaluru, Karnataka, 562157, India
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 26, 2023
First Posted
July 25, 2024
Study Start
April 8, 2016
Primary Completion
June 7, 2016
Study Completion
May 11, 2017
Last Updated
July 29, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share