Periodontitis, ChronicNCT03264118
Effects of Antimicrobial Photodynamic Therapy on Regeneration of Class II Furcation Lesions
A study testing Scaling and root planing and Toluidine Blue O in people with Periodontitis, Chronic and Periodontal Diseases, run by University of Sao Paulo at 2 sites in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Periodontitis, Chronic, Periodontal Diseases, Periodontal Bone Loss
- What is being tested?
- Scaling and root planing and Toluidine Blue O
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesBrazil
- Study dates
- 2 Apr 2017to 22 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of class II furcation lesion in mandibular 1st and 2nd molars
- Mandibular 1st and 2nd molars without caries, erosion or abrasion
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Bauru School of Dentistry
Bauru, São Paulo, 17012-901
Bauru School of Dentistry
Bauru
About this study
Official title: Effects of Antimicrobial Photodynamic Therapy Associated to Biomaterials 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.
- Being tested
- Scaling and root planing, Toluidine Blue O
- Keywords
- Periodontal Guided Tissue Regeneration, Photochemotherapy
- Medical subject headings
- Chronic Periodontitis, Periodontal Diseases, Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scaling and root planingProcedure or surgery
Furcation treatment by scaling and root planing
Toluidine Blue ODrug
Also called Antimicrobial photodynamic therapy
Antimicrobial photodynamic therapy with toluidine blue O (10mg/ml) and red laser.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Decontamination of furcation defect with scaling and root planing only. Receives: Procedure: Scaling and root planing |
| Antimicrobial Photodynamic Therapy | Experimental | Decontamination of furcation defect with scaling and root planing complemented by antimicrobial photodynamic therapy. Receives: Procedure: Scaling and root planing; Drug: Toluidine Blue O |
What is being measured
The primary outcome is the main question the study is designed to answer.
Horizontal probing depth
Measured with a periodontal probe (mm). Ideal if 0.
Measured: one year
Tomographic Bone filling
Complete filling of furcation defect in tomographic images. Ideal is a radiopaque image similar to neighbor bone.
Measured: One year
Secondary outcomes (3)
Probing depth
Distance from gingival margin to bottom of sulcus. Measured with a periodontal probe (mm). Ideal if < 2 mm.
Measured: one year
Clinical Attachment Level
Distance from cemento-enamel junction to bottom of sulcus. Measured with a periodontal probe (mm). Ideal if < 2 mm.
Measured: one year
Bleeding on probing
Visual confirmation of bleeding after probing. Ideal if not bleeding.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2017
- Study start2 Apr 2017
- Primary completion22 Dec 2018
- Study completion22 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Periodontitis, ChronicStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Split-mouth design. One side of mouth is test and the other is control side.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Geistlich Pharma AG
- Responsible party
- Principal investigator, Carla Andreotti Damante, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03264118
- Sponsor's protocol ID
- BauruSchoolDentistryfurcation
- Status last verified
- Feb 2023
- First submitted
- 24 Aug 2017
- Last updated
- 27 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 23731242Avila-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
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Antimicrobial Photodynamic Therapy Associated to Biomaterials on Regeneration of Class II Furcation Lesions
- ClinicalTrials.gov ID
- NCT03264118
- Acronym / sponsor ID
- BauruSchoolDentistryfurcation
- Keywords
- Periodontal Guided Tissue Regeneration, Photochemotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Geistlich Pharma AG
- Study start
- 2 Apr 2017 (actual)
- Primary completion
- 22 Dec 2018 (actual)
- Study completion
- 22 Dec 2018 (actual)
- First posted
- 28 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Split-mouth design. One side of mouth is test and the other is control side.
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Procedure: Scaling and root planingDecontamination of furcation defect with scaling and root planing only. |
| Antimicrobial Photodynamic Therapy | Experimental | Procedure: Scaling and root planing, Drug: Toluidine Blue ODecontamination of furcation defect with scaling and root planing complemented by antimicrobial photodynamic therapy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of class II furcation lesion in mandibular 1st and 2nd molars
- Mandibular 1st and 2nd molars without caries, erosion or abrasion
Key exclusion criteria (6 listed)
- Smoking habit
- Pregnancy
- Use of antibiotics in the last six months
- Periodontal treatment in the last six months
- Endodontic lesion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Scaling and root planingFurcation treatment by scaling and root planing | Procedure or surgery | Antimicrobial Photodynamic Therapy, Control |
| Toluidine Blue OAlso: Antimicrobial photodynamic therapyAntimicrobial photodynamic therapy with toluidine blue O (10mg/ml) and red laser. | Drug | Antimicrobial Photodynamic Therapy |
Primary outcome
Horizontal probing depth
Time frame: one year
Measured with a periodontal probe (mm). Ideal if 0.
Tomographic Bone filling
Time frame: One year
Complete filling of furcation defect in tomographic images. Ideal is a radiopaque image similar to neighbor bone.
3 secondary outcomes
Probing depth
Time frame: one year
Clinical Attachment Level
Time frame: one year
Bleeding on probing
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2023.
- Background: PubMed 23731242Luchesi 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.
- Background: PubMed 25644295Avila-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.
- Individual participant dataSharing planned: No
Related trials for Periodontitis, Chronic
Not yet recruiting
Clinical and Inflammatory Outcomes of Regenerative Endodontic Treatment Using Injectable Platelet-Rich Fibrin in Mature Necrotic Teeth With Chronic Apical Periodontitis.
Chronic Apical Periodontitis, Pulp Necrosis
Recruiting
Effect of Cyperus Articulatus on Bacterial Reduction and Postoperative Pain
Chronic Apical Periodontitis
RecruitingObservational study
Prevalence and Associated Factors of High BMI and Periodontitis in Thai Adults Aged Under 60 Years
Diabete Mellitus, Dyslipidaemia
RecruitingObservational study
Evaluation of Masticatory Performance in Patients With Periodontitis
Periodontitis, Adult, Periodontitis
Recruiting
Postoperative Pain and Success of Single-Visit Root Canal Treatment Using Different Root Canal Sealers in Asymptomatic Teeth
Single-visit, Periapical Periodontitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scaling and root planing and Toluidine Blue O in people with Periodontitis, Chronic and Periodontal Diseases, run by University of Sao Paulo at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Horizontal probing depth (time frame: one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03264118, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2023.