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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Adjuvant Effect of Antimicrobial Photodynamic Therapy on Periodontal Treatment and Salivary Status of Type 1 Diabetes Mellitus Patients

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 Summary: 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.
Sponsor: University of Sao Paulo

Current Primary Outcome:

• Periodontal disease (gingivitis and periodontitis) measured by a periodontal probe and classified according to severity [ Time Frame: 6 months ]
  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 [ Time Frame: 6 months ]
  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.

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Salivary pH and buffering Capacity - collection of stimulated saliva in 10 minutes and measurement of acidity with a pHmeter [ Time Frame: 6 months ]
  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 [ Time Frame: 6 months ]
  Normal glycemia: <100mg/dL

Original Secondary Outcome: Same as current

Information By: University of Sao Paulo

Dates:
Date Received: March 30, 2017
Date Started: March 10, 2017
Date Completion: December 10, 2018
Last Updated: March 30, 2017
Last Verified: March 2017