ClinicalTrials.Veeva

Menu

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

U

University of Sao Paulo

Status

Completed

Conditions

Periodontal Diseases

Treatments

Device: red laser
Drug: methylene blue dye
Procedure: Antimicrobial photodynamic therapy
Procedure: Scaling and root planning

Study type

Interventional

Funder types

Other

Identifiers

NCT02938988
FOBDownSyndrome

Details and patient eligibility

About

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.

.

Full description

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.

Enrollment

33 patients

Sex

All

Ages

15 to 52 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

33 participants in 2 patient groups

Test group
Experimental group
Description:
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.
Treatment:
Drug: methylene blue dye
Procedure: Scaling and root planning
Device: red laser
Procedure: Antimicrobial photodynamic therapy
Control Group
Active Comparator group
Description:
Scaling and root planning Repetition after 3, 7 and 14 days.
Treatment:
Procedure: Scaling and root planning

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems