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

NCT ID: NCT03102892

Last Updated: 2023-03-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-24

Study Completion Date

2020-03-13

Brief Summary

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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

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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.

Conditions

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Diabetes Mellitus, Type 1 Periodontal Diseases Periodontal Pocket

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Scaling Root Planing

Treatment by scaling and root planing. Repetition after 7 and 14 days.

Group Type ACTIVE_COMPARATOR

Scaling root planing

Intervention Type PROCEDURE

Treatment by scaling and root planing alone.

Antimicrobial Photodynamic Therapy

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.

Group Type EXPERIMENTAL

Scaling root planing

Intervention Type PROCEDURE

Treatment by scaling and root planing alone.

Antimicrobial photodynamic therapy

Intervention Type PROCEDURE

Treatment with methylene blue dye and red laser

Interventions

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Scaling root planing

Treatment by scaling and root planing alone.

Intervention Type PROCEDURE

Antimicrobial photodynamic therapy

Treatment with methylene blue dye and red laser

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Carla Andreotti Damante

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Bauru School of Dentistry

Bauru, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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Al-Zahrani MS, Bamshmous SO, Alhassani AA, Al-Sherbini MM. Short-term effects of photodynamic therapy on periodontal status and glycemic control of patients with diabetes. J Periodontol. 2009 Oct;80(10):1568-73. doi: 10.1902/jop.2009.090206.

Reference Type BACKGROUND
PMID: 19792844 (View on PubMed)

Other Identifiers

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BauruSchoolDentistryPDTDM1

Identifier Type: -

Identifier Source: org_study_id

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