NCT03102892

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 6, 2017

Completed
18 days until next milestone

Study Start

First participant enrolled

April 24, 2017

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 13, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 13, 2020

Completed
Last Updated

March 8, 2023

Status Verified

March 1, 2023

Enrollment Period

2.9 years

First QC Date

March 30, 2017

Last Update Submit

March 6, 2023

Conditions

Diabetes Mellitus, Type 1Periodontal DiseasesPeriodontal Pocket

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Salivary pH and buffering Capacity - collection of stimulated saliva in 10 minutes and measurement of acidity with a pHmeter

    6 months

  • Capillary glycemia measured by a glucometer

    6 months

Study Arms (2)

Scaling Root Planing

ACTIVE COMPARATOR

Treatment by scaling and root planing. Repetition after 7 and 14 days.

Procedure: Scaling root planing

Antimicrobial Photodynamic Therapy

EXPERIMENTAL

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 planingProcedure: Antimicrobial photodynamic therapy

Interventions

Scaling root planingPROCEDURE

Treatment by scaling and root planing alone.

Antimicrobial Photodynamic TherapyScaling Root Planing
Antimicrobial photodynamic therapyPROCEDURE

Treatment with methylene blue dye and red laser

Antimicrobial Photodynamic Therapy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bauru School of Dentistry

Bauru, São Paulo, 17012-901, Brazil

Location

Related 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.

    PMID: 19792844BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Periodontal DiseasesPeriodontal Pocket

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesMouth DiseasesStomatognathic DiseasesPeriodontitis

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

March 30, 2017

First Posted

April 6, 2017

Study Start

April 24, 2017

Primary Completion

March 13, 2020

Study Completion

March 13, 2020

Last Updated

March 8, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)