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

University of Sao Paulo60 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Diabetes Mellitus, Type 1 Periodontal Diseases Periodontal Pocket

Interventions

Scaling root planingPROCEDURE

Treatment by scaling and root planing alone.

Antimicrobial photodynamic therapyPROCEDURE

Treatment with methylene blue dye and red laser

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Bauru School of Dentistry

Bauru, São Paulo, Brazil

Outcomes

Primary Outcomes

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%.

Time frame: 6 months

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.

Time frame: 6 months

Secondary Outcomes

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''.

Time frame: 6 months

Capillary glycemia measured by a glucometer

Normal glycemia: \<100mg/dL

Time frame: 6 months

Data from ClinicalTrials.gov

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