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

Periodontal Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02938988
• Other study ID #: FOBDownSyndrome
• Status: Completed
• Phase: N/A
• First received: October 18, 2016
• Last updated: October 18, 2016
• Start date: October 2013
• Est. completion date: October 2016

Study information

• Verified date: October 2016
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 52 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Down Syndrome
• Gingival Diseases
• Periodontal Diseases
• Syndrome

Intervention

Procedure:
• Antimicrobial photodynamic therapy
Described in arm/group
• Scaling and root planning
Described in arm/group

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

Drug:
• methylene blue dye

Locations

Country	Name	City	State
Brazil	Bauru School of Dentistry	Bauru	Sao Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (2)

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. — View Citation

Martins F, Simões 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 Jul 6. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No