Antimicrobial Photodynamic Therapy on Periodontal Treatment and Salivary Status of Type 1 Diabetes Mellitus Patients

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

Adjuvant Effect of Antimicrobial Photodynamic Therapy on Periodontal Treatment and Salivary Status of Type 1 Diabetes Mellitus Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03102892
• Other study ID #: BauruSchoolDentistryPDTDM1
• Status: Terminated
• Phase: N/A
• Start date: April 24, 2017
• Est. completion date: March 13, 2020

Study information

• Verified date: March 2023
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to evaluate adjuvant effect of antimicrobial photodynamic therapy in periodontal treatment and salivary status of type 1 diabetes patients.

Description:

Diabetes Mellitus is a risk factor for periodontal disease increasing its prevalence, extension and severity. Periodontal disease is considered the sixth complication of diabetes. There is a global epidemic of diabetes, including an increase of type 1 diabetes incidence in younger patients. Adjuvant treatments to scaling and root planing as antimicrobial photodynamic therapy show improved clinical outcomes. Thus, the aim of this randomized clinical trial is to evaluate adjuvant effect of antimicrobial photodynamic therapy in periodontal treatment and salivary status of type 1 diabetes patients.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 60
• Est. completion date: March 13, 2020
• Est. primary completion date: March 13, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Diagnose of Type 1 diabetes mellitus
• Age between 18 to 65 years old
• Presence of at least one tooth for hemiarch
• Moderate and severe periodontal disease

Exclusion Criteria:

• Type 2 diabetes mellitus
• Total edentulism
• Smokers
• Pregnancy
• Systemic diseases as other endocrine diseases and blood diseases
• Use of drugs that alter periodontal tissue as phenytoin and cyclosporine

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Periodontal Diseases
• Periodontal Pocket

Intervention

Procedure:
• Scaling root planing
Treatment by scaling and root planing alone.
• Antimicrobial photodynamic therapy
Treatment with methylene blue dye and red laser

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

Al-Zahrani MS, Bamshmous SO, Alhassani AA, Al-Sherbini MM. Short-term effects of photodynamic therapy on periodontal status and glycemic control of patients with diabetes. J Periodontol. 2009 Oct;80(10):1568-73. doi: 10.1902/jop.2009.090206. — 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%.	6 months
Primary	Salivary glucose - collection of stimulated saliva in 10 minutes and measured with a colorimetric kit	Salivary glucose is measured by a colorimetric kit and the values are converted and presented as mg/dL. There are no reference value for this measurement. The analysis is done by means of correlation to blood glucose levels in mg/dL.	6 months
Secondary	Salivary pH and buffering Capacity - collection of stimulated saliva in 10 minutes and measurement of acidity with a pHmeter	Normal Salivary pH = 6 to 7. Buffering capacity: = 5.6 were considered as ''high'', ranging from 4.1 to 5.5 were labelled as ''medium'' and those =4 were defined as ''low''.	6 months
Secondary	Capillary glycemia measured by a glucometer	Normal glycemia: <100mg/dL	6 months