ClinicalTrials.gg
CompletedNCT03264118Updated Feb 27, 2023

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

An interventional study of Scaling and root planing and Toluidine Blue O in Periodontitis, Chronic, Periodontal Diseases and Periodontal Bone Loss, sponsored by University of Sao Paulo. Completed at 2 sites in Brazil. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-02-27.

Sponsored by University of Sao Paulo · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Apr 2017, registered Aug 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 24 studies in Chronic Periodontitis with a site in Brazil — none open to participants now, 1 under way, none of them phase 3. Chronic Periodontitis · Brazil.

Enrollment
17th of 23
25 · median 44
Started
2017
with 1 other
No phase
15 of 24
none open now
Registered
19th of 24
by date
Lead sponsor
7 of 24
University of Sao Paulo

Among the 24 studies in Chronic Periodontitis with a site in Brazil, this one is the 17th largest by enrollment of the 23 interventional ones that give a count, is one of 2 that started in 2017, is one of 15 with no phase, and was the 19th registered.

Chronic Periodontitis

377 studies on the registry are indexed under Chronic Periodontitis; 21 are open to participants now.

Browse Chronic Periodontitis studies →

Open to participants now

None of the 24 studies in Chronic Periodontitis with a site in Brazil is open now.

Who these studies take

Of the 13 Chronic Periodontitis studies recruiting now, 7 (54%) set no upper age limit and 5 (38%) stop at 75 or younger; 0 take children under 18; 4 take healthy volunteers.

This study: 18 Years to 70 Years · all sexes · no healthy volunteers.

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Download CSVNarrow it in search →With an account: the 24 studies in Chronic Periodontitis with a site in Brazil as a file.
02

Study 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.

03

Conditions studied

  • Periodontitis, Chronic
  • Periodontal Diseases
  • Periodontal Bone Loss

Keywords

  • Periodontal Guided Tissue Regeneration
  • Photochemotherapy
04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
25 participants (actual)

Study arms

  • Active comparator
    Control

    Decontamination of furcation defect with scaling and root planing only.

    Procedure: Scaling and root planing

  • Experimental
    Antimicrobial Photodynamic Therapy

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

    Procedure: Scaling and root planing · Drug: Toluidine Blue O

Interventions

  • ProcedureScaling and root planing

    Furcation treatment by scaling and root planing

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

    Also known as: Antimicrobial photodynamic therapy

06

What researchers measure

Primary outcomes

  1. Horizontal probing depth

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

    Time frame: one year

  2. Tomographic Bone filling

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

    Time frame: One year

Secondary outcomes

  1. Probing depth

    Distance from gingival margin to bottom of sulcus. Measured with a periodontal probe (mm). Ideal if \< 2 mm.

    Time frame: one year

  2. Clinical Attachment Level

    Distance from cemento-enamel junction to bottom of sulcus. Measured with a periodontal probe (mm). Ideal if \< 2 mm.

    Time frame: one year

  3. Bleeding on probing

    Visual confirmation of bleeding after probing. Ideal if not bleeding.

    Time frame: One year

07

Study locations

2 sites
  • Bauru School of Dentistry
    Bauru, Sao Paulo 17012-901, Brazil
  • Bauru School of Dentistry
    Bauru, Brazil
08

References and documents

Publications

  • 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. PubMed 23731242 ↗
  • 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. PubMed 25644295 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2017 to primary completion in Dec 2018, 20 months.

Of 88 non-industry interventional studies with no phase under Chronic Periodontitis, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 24. This study's 20 months is above that.

Counting every sponsor, half of 89 studies reached it within 15 months; a quarter within 10 and three quarters within 24.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 24, 2017
First posted
Aug 28, 2017
StartActual
Apr 2, 2017
Primary completionActual
Dec 22, 2018
CompletionActual
Dec 22, 2018
Last update
Feb 27, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 27, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03264118
Collaborators
Geistlich Pharma AG
Responsible party
Carla Andreotti Damante (Associate professor, University of Sao Paulo) — Principal investigator
First posted
Aug 28, 2017
Start date
Apr 2, 2017
Primary completion
Dec 22, 2018
Completion
Dec 22, 2018
Last update
Feb 27, 2023

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Tolonium Chloride

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