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

Not Applicable

Terminated

• Conditions: Periodontal Diseases; Periodontal Pocket; Diabetes Mellitus, Type 1

• Registration Number: NCT03102892
• Lead Sponsor: University of Sao Paulo

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.

Study Timeline

• Study First Submitted: 2017-03-30
• Study First Submitted QC: 2017-03-30
• Study First Posted: 2017-04-06
• Study Start: 2017-04-24
• Primary Completion: 2020-03-13
• Study Completion: 2020-03-13
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-06
• Last Update Posted: 2023-03-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Salivary glucose - collection of stimulated saliva in 10 minutes and measured with a colorimetric kit	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.
Periodontal disease (gingivitis and periodontitis) measured by a periodontal probe and classified according to severity	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%.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Bauru School of Dentistry; 🇧🇷 Bauru, Sao Paulo, Brazil