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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
Interventions
Procedure: Scaling root planing
Procedure: Antimicrobial photodynamic therapy
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.

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
Read More
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
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Scaling Root PlaningScaling root planingTreatment by scaling and root planing. Repetition after 7 and 14 days.
Antimicrobial Photodynamic TherapyScaling root planingScaling 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.
Antimicrobial Photodynamic TherapyAntimicrobial photodynamic therapyScaling 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.
Primary Outcome Measures
NameTimeMethod
Salivary glucose - collection of stimulated saliva in 10 minutes and measured with a colorimetric kit6 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 severity6 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
NameTimeMethod
Salivary pH and buffering Capacity - collection of stimulated saliva in 10 minutes and measurement of acidity with a pHmeter6 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 glucometer6 months

Normal glycemia: \<100mg/dL

Trial Locations

Locations (1)

Bauru School of Dentistry

🇧🇷

Bauru, Sao Paulo, Brazil

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