Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Adjunct Photodynamic Therapy in the Treatment of Type 2 Diabetic Patients With Chronic Periodontitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02627534
Recruitment Status : Completed
First Posted : December 11, 2015
Last Update Posted : December 14, 2015
Sponsor:
Information provided by (Responsible Party):
Nídia Cristina Castro dos Santos, Universidade Estadual Paulista Júlio de Mesquita Filho

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
Chronic Periodontitis Diabetes Mellitus Procedure: Ultrasonic debridement Procedure: Antimicrobial photodynamic therapy Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Local Effects of Adjunct Photodynamic Therapy in the Treatment of Type 2 Diabetic Patients With Chronic Periodontitis: Split-mouth Randomized Triple-blind Clinical Trial
Study Start Date : April 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : October 2015

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.

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.




Primary Outcome Measures :
  1. Probing Depth [ Time Frame: Reductions in Probing Depth was compared at baseline and 180 days ]
    Assessed with manual probe (North Carolina, Hu-Friedy)


Secondary Outcome Measures :
  1. Clinical Attachment Level [ Time Frame: Clinical Attachment Level gain was compared at baseline and 180 days ]
    Assessed with manual probe (North Carolina, Hu-Friedy)


Other Outcome Measures:
  1. Gingival Recession [ Time Frame: Gingival Recession changes was compared at baseline and 180 days ]
    Assessed with manual probe (North Carolina, Hu-Friedy)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02627534


Locations
Layout table for location information
Brazil
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
Layout table for investigator information
Study Director: Mauro P Santamaria, PhD ICT - UNESP

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Nídia Cristina Castro dos Santos, DDS, Universidade Estadual Paulista Júlio de Mesquita Filho
ClinicalTrials.gov Identifier: NCT02627534     History of Changes
Other Study ID Numbers: NSFOSJC
First Posted: December 11, 2015    Key Record Dates
Last Update Posted: December 14, 2015
Last Verified: December 2015

Keywords provided by Nídia Cristina Castro dos Santos, Universidade Estadual Paulista Júlio de Mesquita Filho:
Photodynamic therapy
Ultrasonic debridement
Chronic periodontitis
Type 2 diabetes

Additional relevant MeSH terms:
Layout table for MeSH terms
Chronic Periodontitis
Periodontitis
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Anti-Bacterial Agents
Anti-Infective Agents