Effects of Adjunct Photodynamic Therapy in the Treatment of Type 2 Diabetic Patients With Chronic Periodontitis
NCT ID: NCT02627534
Last Updated: 2015-12-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2014-04-30
2015-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Ultrasonic Debridement (UD)
Ultrasonic Debridement (UD) (n=20)
Ultrasonic debridement
All periodontal pockets received ultrasonic debridement (Cavitron, Dentsply) with specific inserts (UI25KSF10S, Hu-Friedy). All diseased sites were instrumented in one session by an experienced periodontist.
UD + Antimicrobial Photodynamic Therapy
Ultrasonic Debridement + aPDT (UD+aPDT) (n=20)
Ultrasonic debridement
All periodontal pockets received ultrasonic debridement (Cavitron, Dentsply) with specific inserts (UI25KSF10S, Hu-Friedy). All diseased sites were instrumented in one session by an experienced periodontist.
Antimicrobial photodynamic therapy
After ultrasonic debridement, one randomly selected periodontal pocket received an additional aPDT performed by a trained operator (NMRBA). One pocket with probing depth ≥ 5mm in each patient was randomly selected to aPDT. After washing the pocket with saline solution, the photosensitizer (methylene blue 10mg/ml) was applied to the bottom of the pocket in a coronal direction. Following this, the pocket was exposed to a diode laser light with a fibre optic application for 1 min (Thera Lase DMC - Brazil), with wavelength of 660nm, power of 60mW and fluency of 129J/cm2.
Interventions
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Ultrasonic debridement
All periodontal pockets received ultrasonic debridement (Cavitron, Dentsply) with specific inserts (UI25KSF10S, Hu-Friedy). All diseased sites were instrumented in one session by an experienced periodontist.
Antimicrobial photodynamic therapy
After ultrasonic debridement, one randomly selected periodontal pocket received an additional aPDT performed by a trained operator (NMRBA). One pocket with probing depth ≥ 5mm in each patient was randomly selected to aPDT. After washing the pocket with saline solution, the photosensitizer (methylene blue 10mg/ml) was applied to the bottom of the pocket in a coronal direction. Following this, the pocket was exposed to a diode laser light with a fibre optic application for 1 min (Thera Lase DMC - Brazil), with wavelength of 660nm, power of 60mW and fluency of 129J/cm2.
Eligibility Criteria
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Inclusion Criteria
* DM treatment with oral hypoglycemic agents or insulin supplementation and diet
* glycated hemoglobin (HbA1c) levels from 6.5% to 11%
* at least 15 teeth (excluding third molars and teeth indicated for extraction)
* moderate to severe generalized chronic periodontitis (Armitage, 1999)
* agree and sign the formal consent to participate in the study after receiving an explanation of risks and benefits from an individual who was not a member of the study (Resolution number 196 - October, 1996, and Ethics and Code of Professional Conduct in Dentistry - CFO179/93).
Exclusion Criteria
* SRP in the previous 6 months
* antimicrobial therapies in the previous 6 months
* anti-inflammatory therapies in the previous 6 months
* systemic conditions, other than DM, that could affect the progression of chronic periodontitis
* current use of medication that could interfere with periodontal response to treatment
* pregnancy or lactation
* smoking
35 Years
ALL
No
Sponsors
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Universidade Estadual Paulista Júlio de Mesquita Filho
OTHER
Responsible Party
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Nídia Cristina Castro dos Santos
DDS
Principal Investigators
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Mauro P Santamaria, PhD
Role: STUDY_DIRECTOR
ICT - UNESP
Locations
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Instituto de Ciência e Tecnologia de São José dos Campos - UNESP
Sâo José Dos Campos, São Paulo, Brazil
Countries
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References
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Castro Dos Santos NC, Andere NM, Araujo CF, de Marco AC, Dos Santos LM, Jardini MA, Santamaria MP. Local adjunct effect of antimicrobial photodynamic therapy for the treatment of chronic periodontitis in type 2 diabetics: split-mouth double-blind randomized controlled clinical trial. Lasers Med Sci. 2016 Nov;31(8):1633-1640. doi: 10.1007/s10103-016-2030-8. Epub 2016 Jul 22.
Other Identifiers
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NSFOSJC
Identifier Type: -
Identifier Source: org_study_id