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

U

University of Sao Paulo

Status

Terminated

Conditions

Diabetes Mellitus, Type 1
Periodontal Pocket
Periodontal Diseases

Treatments

Procedure: Antimicrobial photodynamic therapy
Procedure: Scaling root planing

Study type

Interventional

Funder types

Other

Identifiers

NCT03102892
BauruSchoolDentistryPDTDM1

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

60 participants in 2 patient groups

Scaling Root Planing
Active Comparator group
Description:
Treatment by scaling and root planing. Repetition after 7 and 14 days.
Treatment:
Procedure: Scaling root planing
Antimicrobial Photodynamic Therapy
Experimental group
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.
Treatment:
Procedure: Scaling root planing
Procedure: Antimicrobial photodynamic therapy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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