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

Full-mouth Antimicrobial Photodynamic Therapy as an Adjunct to Non-surgical Periodontal Disease Treatment in Down's Syndrome Patients

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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Study Overview

• Status: Completed
• Conditions: Periodontal Diseases
• Intervention / Treatment: Procedure: Antimicrobial photodynamic therapy; Procedure: Scaling and root planning; Device: red laser; Drug: methylene blue dye

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.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo
    • Bauru, Sao Paulo, Brazil, 17012-901
      • Bauru School of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 52 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Periodontal disease (gingivitis and periodontitis) measured by a periodontal probe and classified according to severity	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.	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Obesity measured by a tape and a scale	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.	one day

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo

Publications and helpful links

General Publications

• Ferreira R, Michel RC, Greghi SL, Resende ML, Sant'Ana AC, Damante CA, Zangrando MS. Prevention and Periodontal Treatment in Down Syndrome Patients: A Systematic Review. PLoS One. 2016 Jun 29;11(6):e0158339. doi: 10.1371/journal.pone.0158339. eCollection 2016.
• Martins F, Simoes A, Oliveira M, Luiz AC, Gallottini M, Pannuti C. Efficacy of antimicrobial photodynamic therapy as an adjuvant in periodontal treatment in Down syndrome patients. Lasers Med Sci. 2016 Dec;31(9):1977-1981. doi: 10.1007/s10103-016-2020-x. Epub 2016 Jul 6.

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: October 18, 2016
• First Submitted That Met QC Criteria: October 18, 2016
• First Posted (Estimate): October 19, 2016

Study Record Updates

• Last Update Posted (Estimate): October 19, 2016
• Last Update Submitted That Met QC Criteria: October 18, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Down Syndrome; Periodontal Diseases
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Congenital Abnormalities; Genetic Diseases, Inborn; Stomatognathic Diseases; Mouth Diseases; Intellectual Disability; Abnormalities, Multiple; Chromosome Disorders; Down Syndrome; Periodontal Diseases; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Anti-Bacterial Agents; Anti-Infective Agents; Methylene Blue
• Other Study ID Numbers: FOBDownSyndrome

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO