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

Primary Purpose

Chronic Periodontitis, Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Ultrasonic debridement
Antimicrobial photodynamic therapy
Sponsored by
Universidade Estadual Paulista Júlio de Mesquita Filho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Periodontitis focused on measuring Photodynamic therapy, Ultrasonic debridement, Chronic periodontitis, Type 2 diabetes

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Instituto de Ciência e Tecnologia de São José dos Campos - UNESP

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Ultrasonic Debridement (UD)

UD + Antimicrobial Photodynamic Therapy

Arm Description

Ultrasonic Debridement (UD) (n=20)

Ultrasonic Debridement + aPDT (UD+aPDT) (n=20)

Outcomes

Primary Outcome Measures

Probing Depth
Assessed with manual probe (North Carolina, Hu-Friedy)

Secondary Outcome Measures

Clinical Attachment Level
Assessed with manual probe (North Carolina, Hu-Friedy)

Full Information

First Posted
November 25, 2015
Last Updated
December 10, 2015
Sponsor
Universidade Estadual Paulista Júlio de Mesquita Filho
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1. Study Identification

Unique Protocol Identification Number
NCT02627534
Brief Title
Effects of Adjunct Photodynamic Therapy in the Treatment of Type 2 Diabetic Patients With Chronic Periodontitis
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 Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Estadual Paulista Júlio de Mesquita Filho

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis, Diabetes Mellitus
Keywords
Photodynamic therapy, Ultrasonic debridement, Chronic periodontitis, Type 2 diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ultrasonic Debridement (UD)
Arm Type
Active Comparator
Arm Description
Ultrasonic Debridement (UD) (n=20)
Arm Title
UD + Antimicrobial Photodynamic Therapy
Arm Type
Experimental
Arm Description
Ultrasonic Debridement + aPDT (UD+aPDT) (n=20)
Intervention Type
Procedure
Intervention Name(s)
Ultrasonic debridement
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Antimicrobial photodynamic therapy
Intervention Description
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 Measure Information:
Title
Probing Depth
Description
Assessed with manual probe (North Carolina, Hu-Friedy)
Time Frame
Reductions in Probing Depth was compared at baseline and 180 days
Secondary Outcome Measure Information:
Title
Clinical Attachment Level
Description
Assessed with manual probe (North Carolina, Hu-Friedy)
Time Frame
Clinical Attachment Level gain was compared at baseline and 180 days
Other Pre-specified Outcome Measures:
Title
Gingival Recession
Description
Assessed with manual probe (North Carolina, Hu-Friedy)
Time Frame
Gingival Recession changes was compared at baseline and 180 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mauro P Santamaria, PhD
Organizational Affiliation
ICT - UNESP
Official's Role
Study Director
Facility Information:
Facility Name
Instituto de Ciência e Tecnologia de São José dos Campos - UNESP
City
Sâo José dos Campos
State/Province
São Paulo
ZIP/Postal Code
12245-000
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
27448223
Citation
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.
Results Reference
derived

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

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