Effects of Adjunct Photodynamic Therapy in the Treatment of Type 2 Diabetic Patients With Chronic Periodontitis
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
Diabetes mellitus (DM) has become a global epidemic. Its complications can have a significant impact on quality of life, longevity, and costs in public health. The World Health Organization (WHO) estimates that by 2030, 439 million people will suffer from diabetes, around 10% of the world adult population (WHO, 2011). Periodontal Diseases are considered the sixth complication of DM. This close relationship between both diseases is characterized by mutual influence. Thus, an appropriate control of periodontal disease may facilitate the DM control, improving quality of life on diabetes patients. Besides that, 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. Therefore, the aim of the present study is to investigate the effectiveness of antimicrobial photodynamic therapy as adjunct to full-mouth debridement for the treatment of periodontitis in type 2 diabetic patients through a split-mouth randomized triple-blind clinical trial.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Ultrasonic Debridement (UD) Ultrasonic Debridement (UD) (n=20) |
Procedure: 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.
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| Experimental: UD + Antimicrobial Photodynamic Therapy Ultrasonic Debridement + aPDT (UD+aPDT) (n=20) |
Procedure: 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.
Procedure: 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.
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Outcome Measures
Primary Outcome Measures
- Probing Depth [Reductions in Probing Depth was compared at baseline and 180 days]
Assessed with manual probe (North Carolina, Hu-Friedy)
Secondary Outcome Measures
- Clinical Attachment Level [Clinical Attachment Level gain was compared at baseline and 180 days]
Assessed with manual probe (North Carolina, Hu-Friedy)
Other Outcome Measures
- Gingival Recession [Gingival Recession changes was compared at baseline and 180 days]
Assessed with manual probe (North Carolina, Hu-Friedy)
Eligibility Criteria
Criteria
Inclusion Criteria:
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diagnosis of type 2 DM for ≥5 years
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DM treatment with oral hypoglycemic agents or insulin supplementation and diet
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glycated hemoglobin (HbA1c) levels from 6.5% to 11%
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at least 15 teeth (excluding third molars and teeth indicated for extraction)
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moderate to severe generalized chronic periodontitis (Armitage, 1999)
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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:
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medical conditions that required prophylactic antimicrobial coverage
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SRP in the previous 6 months
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antimicrobial therapies in the previous 6 months
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anti-inflammatory therapies in the previous 6 months
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systemic conditions, other than DM, that could affect the progression of chronic periodontitis
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current use of medication that could interfere with periodontal response to treatment
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pregnancy or lactation
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smoking
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Instituto de Ciência e Tecnologia de São José dos Campos - UNESP | Sâo José dos Campos | São Paulo | Brazil | 12245-000 |
Sponsors and Collaborators
- Universidade Estadual Paulista Júlio de Mesquita Filho
Investigators
- Study Director: Mauro P Santamaria, PhD, ICT - UNESP
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NSFOSJC