NCT03264118

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 2, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 24, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 28, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2018

Completed
Last Updated

February 27, 2023

Status Verified

February 1, 2023

Enrollment Period

1.7 years

First QC Date

August 24, 2017

Last Update Submit

February 24, 2023

Conditions

Keywords

Periodontal Guided Tissue RegenerationPhotochemotherapy

Outcome Measures

Primary Outcomes (2)

  • Horizontal probing depth

    Measured with a periodontal probe (mm). Ideal if 0.

    one year

  • Tomographic Bone filling

    Complete filling of furcation defect in tomographic images. Ideal is a radiopaque image similar to neighbor bone.

    One year

Secondary Outcomes (3)

  • Probing depth

    one year

  • Clinical Attachment Level

    one year

  • Bleeding on probing

    One year

Study Arms (2)

Control

ACTIVE COMPARATOR

Decontamination of furcation defect with scaling and root planing only.

Procedure: Scaling and root planing

Antimicrobial Photodynamic Therapy

EXPERIMENTAL

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

Procedure: Scaling and root planingDrug: Toluidine Blue O

Interventions

Furcation treatment by scaling and root planing

Antimicrobial Photodynamic TherapyControl

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

Also known as: Antimicrobial photodynamic therapy
Antimicrobial Photodynamic Therapy

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Bauru School of Dentistry

Bauru, São Paulo, 17012-901, Brazil

Location

Bauru School of Dentistry

Bauru, Brazil

Location

Related Publications (2)

  • 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.

    PMID: 23731242BACKGROUND
  • 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.

    PMID: 25644295BACKGROUND

MeSH Terms

Conditions

Chronic PeriodontitisPeriodontal DiseasesAlveolar Bone Loss

Interventions

Tooth ExfoliationRoot PlaningTolonium Chloride

Condition Hierarchy (Ancestors)

PeriodontitisMouth DiseasesStomatognathic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBone ResorptionBone DiseasesMusculoskeletal DiseasesPeriodontal Atrophy

Intervention Hierarchy (Ancestors)

Dental Physiological PhenomenaDigestive System and Oral Physiological PhenomenaDental ScalingDental ProphylaxisPeriodonticsDentistrySubgingival CurettagePreventive DentistryPhenothiazinesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Split-mouth design. One side of mouth is test and the other is control side.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

August 24, 2017

First Posted

August 28, 2017

Study Start

April 2, 2017

Primary Completion

December 22, 2018

Study Completion

December 22, 2018

Last Updated

February 27, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations