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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03264118
Other study ID # BauruSchoolDentistryfurcation
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 2, 2017
Est. completion date December 22, 2018

Study information

Verified date February 2023
Source University of Sao Paulo
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date December 22, 2018
Est. primary completion date December 22, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Study Design


Intervention

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.

Locations

Country Name City State
Brazil Bauru School of Dentistry Bauru Sao Paulo
Brazil Bauru School of Dentistry Bauru

Sponsors (2)

Lead Sponsor Collaborator
University of Sao Paulo Geistlich Pharma AG

Country where clinical trial is conducted

Brazil, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Horizontal probing depth Measured with a periodontal probe (mm). Ideal if 0. one year
Primary Tomographic Bone filling Complete filling of furcation defect in tomographic images. Ideal is a radiopaque image similar to neighbor bone. One year
Secondary Probing depth Distance from gingival margin to bottom of sulcus. Measured with a periodontal probe (mm). Ideal if < 2 mm. one year
Secondary Clinical Attachment Level Distance from cemento-enamel junction to bottom of sulcus. Measured with a periodontal probe (mm). Ideal if < 2 mm. one year
Secondary Bleeding on probing Visual confirmation of bleeding after probing. Ideal if not bleeding. One year
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