Effects of Antimicrobial Photodynamic Therapy on Regeneration of Class II Furcation Lesions
1 other identifier
interventional
25
1 country
2
Brief Summary
The aim of this study is to evaluate the additional effect of antimicrobial photodynamic therapy regeneration treatment of mandibular furcation lesions when associated to bovine bone and porcine collagen membrane.
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 2017
2 active sites
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 2, 2017
CompletedFirst Submitted
Initial submission to the registry
August 24, 2017
CompletedFirst Posted
Study publicly available on registry
August 28, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 22, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 22, 2018
CompletedFebruary 27, 2023
February 1, 2023
1.7 years
August 24, 2017
February 24, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Horizontal probing depth
Measured with a periodontal probe (mm). Ideal if 0.
one year
Tomographic Bone filling
Complete filling of furcation defect in tomographic images. Ideal is a radiopaque image similar to neighbor bone.
One year
Secondary Outcomes (3)
Probing depth
one year
Clinical Attachment Level
one year
Bleeding on probing
One year
Study Arms (2)
Control
ACTIVE COMPARATORDecontamination of furcation defect with scaling and root planing only.
Antimicrobial Photodynamic Therapy
EXPERIMENTALDecontamination of furcation defect with scaling and root planing complemented by antimicrobial photodynamic therapy.
Interventions
Furcation treatment by scaling and root planing
Antimicrobial photodynamic therapy with toluidine blue O (10mg/ml) and red laser.
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of class II furcation lesion in mandibular 1st and 2nd molars
- Mandibular 1st and 2nd molars without caries, erosion or abrasion
You may not qualify if:
- Smoking habit
- Pregnancy
- Use of antibiotics in the last six months
- Periodontal treatment in the last six months
- Endodontic lesion
- Systemic diseases that impair wound healing
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Sao Paulolead
- Geistlich Pharma AGcollaborator
Study Sites (2)
Bauru School of Dentistry
Bauru, São Paulo, 17012-901, Brazil
Bauru School of Dentistry
Bauru, Brazil
Related Publications (2)
Luchesi VH, Pimentel SP, Kolbe MF, Ribeiro FV, Casarin RC, Nociti FH Jr, Sallum EA, Casati MZ. Photodynamic therapy in the treatment of class II furcation: a randomized controlled clinical trial. J Clin Periodontol. 2013 Aug;40(8):781-8. doi: 10.1111/jcpe.12121. Epub 2013 Jun 3.
PMID: 23731242BACKGROUNDAvila-Ortiz G, De Buitrago JG, Reddy MS. Periodontal regeneration - furcation defects: a systematic review from the AAP Regeneration Workshop. J Periodontol. 2015 Feb;86(2 Suppl):S108-30. doi: 10.1902/jop.2015.130677.
PMID: 25644295BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor
Study Record Dates
First Submitted
August 24, 2017
First Posted
August 28, 2017
Study Start
April 2, 2017
Primary Completion
December 22, 2018
Study Completion
December 22, 2018
Last Updated
February 27, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share