ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03102892
Recruitment Status : Recruiting
First Posted : April 6, 2017
Last Update Posted : May 3, 2018
Sponsor:
Information provided by (Responsible Party):
Carla Andreotti Damante, University of Sao Paulo

Brief 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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Periodontal Diseases Periodontal Pocket Procedure: Scaling root planing Procedure: Antimicrobial photodynamic therapy Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Adjuvant Effect of Antimicrobial Photodynamic Therapy on Periodontal Treatment and Salivary Status of Type 1 Diabetes Mellitus Patients
Actual Study Start Date : March 10, 2017
Estimated Primary Completion Date : October 10, 2018
Estimated Study Completion Date : December 10, 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Periodontal disease (gingivitis and periodontitis) measured by a periodontal probe and classified according to severity [ Time Frame: 6 months ]
    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%.

  2. Salivary glucose - collection of stimulated saliva in 10 minutes and measured with a colorimetric kit [ Time Frame: 6 months ]
    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.


Secondary Outcome Measures :
  1. Salivary pH and buffering Capacity - collection of stimulated saliva in 10 minutes and measurement of acidity with a pHmeter [ Time Frame: 6 months ]
    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''.

  2. Capillary glycemia measured by a glucometer [ Time Frame: 6 months ]
    Normal glycemia: <100mg/dL



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03102892


Contacts
Contact: Carla Damante, PhD 55 14 32358278 cdamante@usp.br

Locations
Brazil
Bauru School of Dentistry Recruiting
Bauru, Sao Paulo, Brazil, 17012-901
Contact: Carla Damante, PhD    55 14 32358278    cdamante@usp.br   
Sponsors and Collaborators
University of Sao Paulo

Publications:
Responsible Party: Carla Andreotti Damante, Associate professor, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT03102892     History of Changes
Other Study ID Numbers: BauruSchoolDentistryPDTDM1
First Posted: April 6, 2017    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Periodontal Diseases
Gingival Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Mouth Diseases
Stomatognathic Diseases
Diabetes Mellitus
Diabetes Mellitus, Type 1
Periodontal Pocket
Periodontitis
Anti-Infective Agents
Anti-Bacterial Agents