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

Overview

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.

Full Title of Study: “Effects of Antimicrobial Photodynamic Therapy Associated to Biomaterials on Regeneration of Class II Furcation Lesions”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: December 22, 2018

Interventions

  • 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.

Arms, Groups and Cohorts

  • Active Comparator: Control
    • Decontamination of furcation defect with scaling and root planing only.
  • Experimental: Antimicrobial Photodynamic Therapy
    • Decontamination of furcation defect with scaling and root planing complemented by antimicrobial photodynamic therapy.

Clinical Trial Outcome Measures

Primary Measures

  • Horizontal probing depth
    • Time Frame: one year
    • Measured with a periodontal probe (mm). Ideal if 0.
  • 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 Measures

  • Probing depth
    • Time Frame: one year
    • Distance from gingival margin to bottom of sulcus. Measured with a periodontal probe (mm). Ideal if < 2 mm.
  • 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.
  • Bleeding on probing
    • Time Frame: One year
    • Visual confirmation of bleeding after probing. Ideal if not bleeding.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Sao Paulo
  • Collaborator
    • Geistlich Pharma AG
  • Provider of Information About this Clinical Study
    • Principal Investigator: Carla Andreotti Damante, Associate professor – University of Sao Paulo

References

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.

Avila-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.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.