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Trial record 99 of 165 for:    trisomy21 NOT prenatal

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

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ClinicalTrials.gov Identifier: NCT02938988
Recruitment Status : Completed
First Posted : October 19, 2016
Last Update Posted : October 19, 2016
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Carla Andreotti Damante, University of Sao Paulo

Brief Summary:

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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Condition or disease Intervention/treatment Phase
Periodontal Diseases Procedure: Antimicrobial photodynamic therapy Procedure: Scaling and root planning Device: red laser Drug: methylene blue dye Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Full-mouth Antimicrobial Photodynamic Therapy as an Adjunct to Non-surgical Periodontal Disease Treatment in Down's Syndrome Patients
Study Start Date : October 2013
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Procedure: Antimicrobial photodynamic therapy
Described in arm/group

Procedure: Scaling and root planning
Described in arm/group

Device: red laser
658nm; 0.1W; 2229J/cm², 10s per point

Drug: methylene blue dye
Active Comparator: Control Group
Scaling and root planning Repetition after 3, 7 and 14 days.
Procedure: Scaling and root planning
Described in arm/group




Primary Outcome Measures :
  1. Periodontal disease (gingivitis and periodontitis) measured by a periodontal probe and classified according to severity [ Time Frame: one year ]
    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%. Prevalence of periodontal disease was the sum of gingivitis, mild, moderate and severe periodontitis.


Secondary Outcome Measures :
  1. Obesity measured by a tape and a scale [ Time Frame: one day ]
    Obese if: body mass index - BMI ≥ 25 Kg/m2 (weight in kilograms, height in meters) Obese if: waist-to-hip ratio - WHR >0.85 for women. >0.9 for men. (measurement in centimeters) Obese if: waist circumference - > 80 cm for women and >94 cm for men.



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Ages Eligible for Study:   15 Years to 52 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02938988


Locations
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Brazil
Bauru School of Dentistry
Bauru, Sao Paulo, Brazil, 17012-901
Sponsors and Collaborators
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo

Publications:
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Responsible Party: Carla Andreotti Damante, Associate professor, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02938988     History of Changes
Other Study ID Numbers: FOBDownSyndrome
First Posted: October 19, 2016    Key Record Dates
Last Update Posted: October 19, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Carla Andreotti Damante, University of Sao Paulo:
Periodontal Diseases
Down Syndrome

Additional relevant MeSH terms:
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Down Syndrome
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn
Anti-Infective Agents
Anti-Bacterial Agents
Methylene Blue
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action