search
Back to results

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

Primary Purpose

Periodontitis, Chronic, Periodontal Diseases, Periodontal Bone Loss

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Scaling and root planing
Toluidine Blue O
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis, Chronic focused on measuring Periodontal Guided Tissue Regeneration, Photochemotherapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bauru School of Dentistry
  • Bauru School of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control

Antimicrobial Photodynamic Therapy

Arm Description

Decontamination of furcation defect with scaling and root planing only.

Decontamination of furcation defect with scaling and root planing complemented by antimicrobial photodynamic therapy.

Outcomes

Primary Outcome Measures

Horizontal probing depth
Measured with a periodontal probe (mm). Ideal if 0.
Tomographic Bone filling
Complete filling of furcation defect in tomographic images. Ideal is a radiopaque image similar to neighbor bone.

Secondary Outcome Measures

Probing depth
Distance from gingival margin to bottom of sulcus. Measured with a periodontal probe (mm). Ideal if < 2 mm.
Clinical Attachment Level
Distance from cemento-enamel junction to bottom of sulcus. Measured with a periodontal probe (mm). Ideal if < 2 mm.
Bleeding on probing
Visual confirmation of bleeding after probing. Ideal if not bleeding.

Full Information

First Posted
August 24, 2017
Last Updated
February 24, 2023
Sponsor
University of Sao Paulo
Collaborators
Geistlich Pharma AG
search

1. Study Identification

Unique Protocol Identification Number
NCT03264118
Brief Title
Effects of Antimicrobial Photodynamic Therapy on Regeneration of Class II Furcation Lesions
Official Title
Effects of Antimicrobial Photodynamic Therapy Associated to Biomaterials on Regeneration of Class II Furcation Lesions
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
April 2, 2017 (Actual)
Primary Completion Date
December 22, 2018 (Actual)
Study Completion Date
December 22, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
Collaborators
Geistlich Pharma AG

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis, Chronic, Periodontal Diseases, Periodontal Bone Loss
Keywords
Periodontal Guided Tissue Regeneration, Photochemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Split-mouth design. One side of mouth is test and the other is control side.
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Description
Decontamination of furcation defect with scaling and root planing only.
Arm Title
Antimicrobial Photodynamic Therapy
Arm Type
Experimental
Arm Description
Decontamination of furcation defect with scaling and root planing complemented by antimicrobial photodynamic therapy.
Intervention Type
Procedure
Intervention Name(s)
Scaling and root planing
Intervention Description
Furcation treatment by scaling and root planing
Intervention Type
Drug
Intervention Name(s)
Toluidine Blue O
Other Intervention Name(s)
Antimicrobial photodynamic therapy
Intervention Description
Antimicrobial photodynamic therapy with toluidine blue O (10mg/ml) and red laser.
Primary Outcome Measure Information:
Title
Horizontal probing depth
Description
Measured with a periodontal probe (mm). Ideal if 0.
Time Frame
one year
Title
Tomographic Bone filling
Description
Complete filling of furcation defect in tomographic images. Ideal is a radiopaque image similar to neighbor bone.
Time Frame
One year
Secondary Outcome Measure Information:
Title
Probing depth
Description
Distance from gingival margin to bottom of sulcus. Measured with a periodontal probe (mm). Ideal if < 2 mm.
Time Frame
one year
Title
Clinical Attachment Level
Description
Distance from cemento-enamel junction to bottom of sulcus. Measured with a periodontal probe (mm). Ideal if < 2 mm.
Time Frame
one year
Title
Bleeding on probing
Description
Visual confirmation of bleeding after probing. Ideal if not bleeding.
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Bauru School of Dentistry
City
Bauru
State/Province
Sao Paulo
ZIP/Postal Code
17012-901
Country
Brazil
Facility Name
Bauru School of Dentistry
City
Bauru
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23731242
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.
Results Reference
background
PubMed Identifier
25644295
Citation
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs