Effects of Adjunct Photodynamic Therapy in the Treatment of Type 2 Diabetic Patients With Chronic Periodontitis
Local Effects of Adjunct Photodynamic Therapy in the Treatment of Type 2 Diabetic Patients With Chronic Periodontitis: Split-mouth Randomized Triple-blind Clinical Trial
1 other identifier
interventional
20
1 country
1
Brief Summary
Periodontal Diseases are considered the sixth complication of Diabetes Mellitus (DM). This close relationship between both diseases is characterized by mutual influence. The presence of DM might impair prognosis of diverse dental treatments due to its inflammatory nature, negative influence on wound healing, on bone biology, and the establishment of infections. Consequently, knowledge of new dental therapies and the biology of dental treatments for chronic periodontitis in diabetic patients can enhance quality of life and make these treatments more adequate for this common profile of patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 25, 2015
CompletedFirst Posted
Study publicly available on registry
December 11, 2015
CompletedDecember 14, 2015
December 1, 2015
11 months
November 25, 2015
December 10, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Probing Depth
Assessed with manual probe (North Carolina, Hu-Friedy)
Reductions in Probing Depth was compared at baseline and 180 days
Secondary Outcomes (1)
Clinical Attachment Level
Clinical Attachment Level gain was compared at baseline and 180 days
Other Outcomes (1)
Gingival Recession
Gingival Recession changes was compared at baseline and 180 days
Study Arms (2)
Ultrasonic Debridement (UD)
ACTIVE COMPARATORUltrasonic Debridement (UD) (n=20)
UD + Antimicrobial Photodynamic Therapy
EXPERIMENTALUltrasonic Debridement + aPDT (UD+aPDT) (n=20)
Interventions
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.
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
You may qualify if:
- diagnosis of type 2 DM for ≥5 years
- 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).
You may not qualify if:
- medical conditions that required prophylactic antimicrobial coverage
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Instituto de Ciência e Tecnologia de São José dos Campos - UNESP
Sâo José Dos Campos, São Paulo, 12245-000, Brazil
Related Publications (1)
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.
PMID: 27448223DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Mauro P Santamaria, PhD
ICT - UNESP
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- DDS
Study Record Dates
First Submitted
November 25, 2015
First Posted
December 11, 2015
Study Start
April 1, 2014
Primary Completion
March 1, 2015
Study Completion
October 1, 2015
Last Updated
December 14, 2015
Record last verified: 2015-12