An interventional study of Ultrasonic debridement and Antimicrobial photodynamic therapy in Chronic Periodontitis and Diabetes Mellitus, sponsored by Universidade Estadual Paulista Júlio de Mesquita Filho. Completed at 1 site in Brazil. Open to participants aged 35 Years and older. Per ClinicalTrials.gov, last updated 2015-12-14.
Sponsored by Universidade Estadual Paulista Júlio de Mesquita Filho · Not applicable, Interventional, and Treatment
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.
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.
1,635 studies on the registry are indexed under Periodontitis; 327 are open to participants now.
This study's enrollment of 20 is below the median of 45 across 1,191 interventional studies indexed under Periodontitis.
Browse Periodontitis studies →Universidade Estadual Paulista Júlio de Mesquita Filho is the lead sponsor of 82 studies on the registry; 9 are open to participants now.
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Exclusion Criteria:
Ultrasonic Debridement (UD) (n=20)
Procedure: Ultrasonic debridement
Ultrasonic Debridement + aPDT (UD+aPDT) (n=20)
Procedure: Ultrasonic debridement · Procedure: Antimicrobial photodynamic therapy
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.
Probing Depth
Assessed with manual probe (North Carolina, Hu-Friedy)
Time frame: Reductions in Probing Depth was compared at baseline and 180 days
Clinical Attachment Level
Assessed with manual probe (North Carolina, Hu-Friedy)
Time frame: Clinical Attachment Level gain was compared at baseline and 180 days
Gingival Recession
Assessed with manual probe (North Carolina, Hu-Friedy)
Time frame: Gingival Recession changes was compared at baseline and 180 days
This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.
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Universidade Estadual Paulista Júlio de Mesquita Filho