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Antimicrobial Photodynamic Therapy on Periodontal Treatment and Salivary Status of Type 1 Diabetes Mellitus Patients

Primary Purpose

Diabetes Mellitus, Type 1, Periodontal Diseases, Periodontal Pocket

Status
Terminated
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Scaling root planing
Antimicrobial photodynamic therapy
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 1

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnose of Type 1 diabetes mellitus
  • Age between 18 to 65 years old
  • Presence of at least one tooth for hemiarch
  • Moderate and severe periodontal disease

Exclusion Criteria:

  • Type 2 diabetes mellitus
  • Total edentulism
  • Smokers
  • Pregnancy
  • Systemic diseases as other endocrine diseases and blood diseases
  • Use of drugs that alter periodontal tissue as phenytoin and cyclosporine

Sites / Locations

  • Bauru School of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Scaling Root Planing

Antimicrobial Photodynamic Therapy

Arm Description

Treatment by scaling and root planing. Repetition after 7 and 14 days.

Scaling and root planing and Antimicrobial photodynamic therapy with red laser (658 nm, 0.1 Watts, 2229 J/cm², 10s per point) and methylene blue dye (10mg/ml). Repetition after 7 and 14 days.

Outcomes

Primary Outcome Measures

Periodontal disease (gingivitis and periodontitis) measured by a periodontal probe and classified according to severity
Severe periodontitis was defined by the presence of ≥ 2 interproximal sites in different teeth with clinical attachment level (CAL) ≥ 6mm and ≥1 interproximal site with periodontal probing depth (PPD) ≥5mm. Moderate periodontitis was defined by the presence of ≥ 2 interproximal sites in different teeth with CAL ≥ 4mm or ≥ 2 interproximal sites in different teeth with PPD ≥5mm. Mild periodontitis was defined as ≥ 2 interproximal sites in different teeth with ≥ 3 mm CAL and ≥ 2 interproximal sites in different teeth with ≥ 4 mm PPD or at least 1 site with PPD ≥ 5 mm (20,21). Gingivitis was determined as follows: Subjects were considered healthy if presented PPD ≤3mm/Bleeding on probing (BOP) extent scores < 10% and with gingivitis if presented PPD ≤3mm/ BOP extent scores >10%.
Salivary glucose - collection of stimulated saliva in 10 minutes and measured with a colorimetric kit
Salivary glucose is measured by a colorimetric kit and the values are converted and presented as mg/dL. There are no reference value for this measurement. The analysis is done by means of correlation to blood glucose levels in mg/dL.

Secondary Outcome Measures

Salivary pH and buffering Capacity - collection of stimulated saliva in 10 minutes and measurement of acidity with a pHmeter
Normal Salivary pH = 6 to 7. Buffering capacity: ≥ 5.6 were considered as ''high'', ranging from 4.1 to 5.5 were labelled as ''medium'' and those ≤4 were defined as ''low''.
Capillary glycemia measured by a glucometer
Normal glycemia: <100mg/dL

Full Information

First Posted
March 30, 2017
Last Updated
March 6, 2023
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT03102892
Brief Title
Antimicrobial Photodynamic Therapy on Periodontal Treatment and Salivary Status of Type 1 Diabetes Mellitus Patients
Official Title
Adjuvant Effect of Antimicrobial Photodynamic Therapy on Periodontal Treatment and Salivary Status of Type 1 Diabetes Mellitus Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Terminated
Why Stopped
COVID-19 pandemics
Study Start Date
April 24, 2017 (Actual)
Primary Completion Date
March 13, 2020 (Actual)
Study Completion Date
March 13, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of this study is to evaluate adjuvant effect of antimicrobial photodynamic therapy in periodontal treatment and salivary status of type 1 diabetes patients.
Detailed Description
Diabetes Mellitus is a risk factor for periodontal disease increasing its prevalence, extension and severity. Periodontal disease is considered the sixth complication of diabetes. There is a global epidemic of diabetes, including an increase of type 1 diabetes incidence in younger patients. Adjuvant treatments to scaling and root planing as antimicrobial photodynamic therapy show improved clinical outcomes. Thus, the aim of this randomized clinical trial is to evaluate adjuvant effect of antimicrobial photodynamic therapy in periodontal treatment and salivary status of type 1 diabetes patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1, Periodontal Diseases, Periodontal Pocket

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Scaling Root Planing
Arm Type
Active Comparator
Arm Description
Treatment by scaling and root planing. Repetition after 7 and 14 days.
Arm Title
Antimicrobial Photodynamic Therapy
Arm Type
Experimental
Arm Description
Scaling and root planing and Antimicrobial photodynamic therapy with red laser (658 nm, 0.1 Watts, 2229 J/cm², 10s per point) and methylene blue dye (10mg/ml). Repetition after 7 and 14 days.
Intervention Type
Procedure
Intervention Name(s)
Scaling root planing
Intervention Description
Treatment by scaling and root planing alone.
Intervention Type
Procedure
Intervention Name(s)
Antimicrobial photodynamic therapy
Intervention Description
Treatment with methylene blue dye and red laser
Primary Outcome Measure Information:
Title
Periodontal disease (gingivitis and periodontitis) measured by a periodontal probe and classified according to severity
Description
Severe periodontitis was defined by the presence of ≥ 2 interproximal sites in different teeth with clinical attachment level (CAL) ≥ 6mm and ≥1 interproximal site with periodontal probing depth (PPD) ≥5mm. Moderate periodontitis was defined by the presence of ≥ 2 interproximal sites in different teeth with CAL ≥ 4mm or ≥ 2 interproximal sites in different teeth with PPD ≥5mm. Mild periodontitis was defined as ≥ 2 interproximal sites in different teeth with ≥ 3 mm CAL and ≥ 2 interproximal sites in different teeth with ≥ 4 mm PPD or at least 1 site with PPD ≥ 5 mm (20,21). Gingivitis was determined as follows: Subjects were considered healthy if presented PPD ≤3mm/Bleeding on probing (BOP) extent scores < 10% and with gingivitis if presented PPD ≤3mm/ BOP extent scores >10%.
Time Frame
6 months
Title
Salivary glucose - collection of stimulated saliva in 10 minutes and measured with a colorimetric kit
Description
Salivary glucose is measured by a colorimetric kit and the values are converted and presented as mg/dL. There are no reference value for this measurement. The analysis is done by means of correlation to blood glucose levels in mg/dL.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Salivary pH and buffering Capacity - collection of stimulated saliva in 10 minutes and measurement of acidity with a pHmeter
Description
Normal Salivary pH = 6 to 7. Buffering capacity: ≥ 5.6 were considered as ''high'', ranging from 4.1 to 5.5 were labelled as ''medium'' and those ≤4 were defined as ''low''.
Time Frame
6 months
Title
Capillary glycemia measured by a glucometer
Description
Normal glycemia: <100mg/dL
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnose of Type 1 diabetes mellitus Age between 18 to 65 years old Presence of at least one tooth for hemiarch Moderate and severe periodontal disease Exclusion Criteria: Type 2 diabetes mellitus Total edentulism Smokers Pregnancy Systemic diseases as other endocrine diseases and blood diseases Use of drugs that alter periodontal tissue as phenytoin and cyclosporine
Facility Information:
Facility Name
Bauru School of Dentistry
City
Bauru
State/Province
Sao Paulo
ZIP/Postal Code
17012-901
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19792844
Citation
Al-Zahrani MS, Bamshmous SO, Alhassani AA, Al-Sherbini MM. Short-term effects of photodynamic therapy on periodontal status and glycemic control of patients with diabetes. J Periodontol. 2009 Oct;80(10):1568-73. doi: 10.1902/jop.2009.090206.
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Antimicrobial Photodynamic Therapy on Periodontal Treatment and Salivary Status of Type 1 Diabetes Mellitus Patients

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