Antimicrobial Photodynamic Therapy as an Adjunct Treatment for Periodontal Disease in Down's Syndrome Patients

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

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2016-10-31

Brief Summary

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The aim of this study was to evaluate the effectiveness of antimicrobial photodynamic therapy as an adjuvant of scaling and root planning for treatment of periodontal disease in patients with Down's Syndrome. After scaling and root planning, half of patients received antimicrobial photodynamic therapy with methylene blue dye and laser and the sessions were repeated after 3, 7 and 14 days. The other half received only scaling and root planning.

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Detailed Description

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Antimicrobial photodynamic therapy (aPDT) has been widely used in Periodontics to obtain reduction of periodontopathogenic bacteria with absence of systemic side effects and minimal bacterial resistance. Therefore, a good adjuvant alternative for periodontal disease treatment arises, especially for patients with Down syndrome (DS) who present greater severity and high prevalence of periodontal disease. Usually aPDT is used as an adjunct therapy to scaling and root planning.

Conditions

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Periodontal Diseases

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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Test group

Scaling and root planning and antimicrobial photodynamic therapy with red laser (658nm; 0.1W; 2229J/cm², 10s per point) and methylene blue dye (100μg/ml). Repetition after 3, 7 and 14 days.

Group Type EXPERIMENTAL

Antimicrobial photodynamic therapy

Intervention Type PROCEDURE

Described in arm/group

Scaling and root planning

Intervention Type PROCEDURE

Described in arm/group

red laser

Intervention Type DEVICE

658nm; 0.1W; 2229J/cm², 10s per point

methylene blue dye

Intervention Type DRUG

Control Group

Scaling and root planning Repetition after 3, 7 and 14 days.

Group Type ACTIVE_COMPARATOR

Scaling and root planning

Intervention Type PROCEDURE

Described in arm/group

Interventions

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Antimicrobial photodynamic therapy

Described in arm/group

Intervention Type PROCEDURE

Scaling and root planning

Described in arm/group

Intervention Type PROCEDURE

red laser

658nm; 0.1W; 2229J/cm², 10s per point

Intervention Type DEVICE

methylene blue dye

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Down's Syndrome Diagnose characterized by the whole chromosomal aneuploidy 15 to 52 years Absence of severe hearing loss could impair the comprehension about the dental treatment Absence of severe visual loss that could impair the comprehension about the dental treatment Presence of at least four teeth being one for hemiarch. Diagnose of gingivitis and periodontitis Absence of acute periodontal disease and necrotizing periodontal disease

Exclusion Criteria

Smokers Use of alcohol Menopause Pregnancy Absence of all teeth Uncontrolled diabetes mellitus Uncontrolled hyperthyroidism Angina Uncontrolled hypertension Coagulopathy Use of illicit drugs Head and neck radiotherapy Chemotherapy Non-cooperative patients or patients with other diseases as autism.

Minimum Eligible Age

15 Years

Maximum Eligible Age

52 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No