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Effects of Antimicrobial Photodynamic Therapy on Regeneration of Class II Furcation Lesions

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ClinicalTrials.gov Identifier: NCT03264118
Recruitment Status : Recruiting
First Posted : August 28, 2017
Last Update Posted : August 28, 2017
Sponsor:
Collaborator:
Geistlich Pharma AG
Information provided by (Responsible Party):
Carla Andreotti Damante, University of Sao Paulo

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.

Condition or disease Intervention/treatment Phase
Periodontitis, Chronic Periodontal Diseases Periodontal Bone Loss Procedure: Scaling and root planing Drug: Toluidine Blue O Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Split-mouth design. One side of mouth is test and the other is control side.
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Antimicrobial Photodynamic Therapy Associated to Biomaterials on Regeneration of Class II Furcation Lesions
Actual Study Start Date : April 2, 2017
Estimated Primary Completion Date : December 22, 2018
Estimated Study Completion Date : December 22, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
Active Comparator: Control
Decontamination of furcation defect with scaling and root planing only.
Procedure: Scaling and root planing
Furcation treatment by scaling and root planing

Experimental: Antimicrobial Photodynamic Therapy
Decontamination of furcation defect with scaling and root planing complemented by antimicrobial photodynamic therapy.
Procedure: Scaling and root planing
Furcation treatment by scaling and root planing

Drug: Toluidine Blue O
Antimicrobial photodynamic therapy with toluidine blue O (10mg/ml) and red laser.
Other Name: Antimicrobial photodynamic therapy




Primary Outcome Measures :
  1. Horizontal probing depth [ Time Frame: one year ]
    Measured with a periodontal probe (mm). Ideal if 0.

  2. Tomographic Bone filling [ Time Frame: One year ]
    Complete filling of furcation defect in tomographic images. Ideal is a radiopaque image similar to neighbor bone.


Secondary Outcome Measures :
  1. Probing depth [ Time Frame: one year ]
    Distance from gingival margin to bottom of sulcus. Measured with a periodontal probe (mm). Ideal if < 2 mm.

  2. Clinical Attachment Level [ Time Frame: one year ]
    Distance from cemento-enamel junction to bottom of sulcus. Measured with a periodontal probe (mm). Ideal if < 2 mm.

  3. Bleeding on probing [ Time Frame: One year ]
    Visual confirmation of bleeding after probing. Ideal if not bleeding.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of class II furcation lesion in mandibular 1st and 2nd molars
  • Mandibular 1st and 2nd molars without caries, erosion or abrasion

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03264118


Locations
Brazil
Bauru School of Dentistry Recruiting
Bauru, Sao Paulo, Brazil, 17012-901
Contact: Carla Damante, PhD    55 14 32358278    cdamante@usp.br   
Bauru School of Dentistry Recruiting
Bauru, Brazil
Contact: Carla Damante, PhD    55 14 32358278    cdamante@usp.br   
Sponsors and Collaborators
University of Sao Paulo
Geistlich Pharma AG

Publications:
Responsible Party: Carla Andreotti Damante, Associate professor, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT03264118     History of Changes
Other Study ID Numbers: BauruSchoolDentistryfurcation
First Posted: August 28, 2017    Key Record Dates
Last Update Posted: August 28, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Carla Andreotti Damante, University of Sao Paulo:
Periodontal Guided Tissue Regeneration
Photochemotherapy

Additional relevant MeSH terms:
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Bone Diseases
Musculoskeletal Diseases
Periodontitis
Alveolar Bone Loss
Chronic Periodontitis
Bone Resorption
Periodontal Atrophy
Anti-Infective Agents
Anti-Bacterial Agents
Tolonium Chloride
Hemostatics
Coagulants
Heparin Antagonists
Molecular Mechanisms of Pharmacological Action