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

December 10, 2015 updated by: Nídia Cristina Castro dos Santos, Universidade Estadual Paulista Júlio de Mesquita Filho

Local Effects of Adjunct Photodynamic Therapy in the Treatment of Type 2 Diabetic Patients With Chronic Periodontitis: Split-mouth Randomized Triple-blind Clinical Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • São Paulo
      • Sâo José dos Campos, São Paulo, Brazil, 12245-000
        • Instituto de Ciência e Tecnologia de São José dos Campos - UNESP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Probing Depth
Time Frame: Reductions in Probing Depth was compared at baseline and 180 days
Assessed with manual probe (North Carolina, Hu-Friedy)
Reductions in Probing Depth was compared at baseline and 180 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Attachment Level
Time Frame: Clinical Attachment Level gain was compared at baseline and 180 days
Assessed with manual probe (North Carolina, Hu-Friedy)
Clinical Attachment Level gain was compared at baseline and 180 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gingival Recession
Time Frame: Gingival Recession changes was compared at baseline and 180 days
Assessed with manual probe (North Carolina, Hu-Friedy)
Gingival Recession changes was compared at baseline and 180 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Estadual Paulista Júlio de Mesquita Filho

Investigators

  • Study Director: Mauro P Santamaria, PhD, ICT - UNESP

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

November 25, 2015

First Submitted That Met QC Criteria

December 8, 2015

First Posted (Estimate)

December 11, 2015

Study Record Updates

Last Update Posted (Estimate)

December 14, 2015

Last Update Submitted That Met QC Criteria

December 10, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NSFOSJC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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