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

Study Overview
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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. .

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.

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

Conditions
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Periodontal Diseases

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


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 52 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test group<br>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<br>* Described in arm/group<br>Procedure: Scaling and root planning<br>* Described in arm/group<br>Device: red laser<br>* 658nm; 0.1W; 2229J/cm², 10s per point<br>Drug: methylene blue dye<br> <br> |
| Active Comparator: Control Group<br>Scaling and root planning Repetition after 3, 7 and 14 days. | Procedure: Scaling and root planning<br>* Described in arm/group<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Periodontal Diseases, Down Syndrome