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Completed

NCT Number: NCT03264118

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

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.

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Key information

Conditions

Periodontitis, Chronic Alveolar Bone Loss Bone Diseases Bone Resorption Chronic Disease Chronic Periodontitis Disease Attributes Mouth Diseases Musculoskeletal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Periodontal Atrophy Periodontal Bone Loss Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bauru School of Dentistry, Bauru, São Paulo, Brazil

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Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Scaling and Root Planing

Procedure

Furcation treatment by scaling and root planing

Toluidine Blue O

Drug

Antimicrobial photodynamic therapy with toluidine blue O (10mg/ml) and red laser.

Other names: Antimicrobial photodynamic therapy

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Collaborators

  • Geistlich Pharma AG

Registry information

Official study title

Effects of Antimicrobial Photodynamic Therapy Associated to Biomaterials on Regeneration of Class II Furcation Lesions

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 28, 2017
Registry last updated
Feb 27, 2023

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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