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

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

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.

Study Overview

• Status: Terminated
• Conditions: Diabetes Mellitus, Type 1; Periodontal Diseases; Periodontal Pocket
• Intervention / Treatment: Procedure: Scaling root planing; Procedure: Antimicrobial photodynamic therapy

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 60
• 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: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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
Active Comparator: Scaling Root Planing; Treatment by scaling and root planing. Repetition after 7 and 14 days.	Procedure: Scaling root planing; Treatment by scaling and root planing alone.
Experimental: Antimicrobial Photodynamic Therapy; Scaling and root planing and Antimicrobial photodynamic therapy with red laser (658 nm, 0.1 Watts, 2229 J/cm², 10s per point) and methylene blue dye (10mg/ml). Repetition after 7 and 14 days.	Procedure: Scaling root planing; Treatment by scaling and root planing alone.; Procedure: Antimicrobial photodynamic therapy; Treatment with methylene blue dye and red laser

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%.	6 months
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Capillary glycemia measured by a glucometer	Normal glycemia: <100mg/dL	6 months

Collaborators and Investigators

• Sponsor: University of Sao Paulo

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2017
• Primary Completion (Actual): March 13, 2020
• Study Completion (Actual): March 13, 2020

Study Registration Dates

• First Submitted: March 30, 2017
• First Submitted That Met QC Criteria: March 30, 2017
• First Posted (Actual): April 6, 2017

Study Record Updates

• Last Update Posted (Estimate): February 28, 2023
• Last Update Submitted That Met QC Criteria: February 24, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Stomatognathic Diseases; Mouth Diseases; Periodontitis; Diabetes Mellitus; Diabetes Mellitus, Type 1; Periodontal Diseases; Periodontal Pocket; Anti-Bacterial Agents; Anti-Infective Agents
• Other Study ID Numbers: BauruSchoolDentistryPDTDM1

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No