Periodontal and Salivary Evaluation of Type 1 Diabetes Mellitus Patients

Sponsor
University of Sao Paulo (Other)
Overall Status
Completed
CT.gov ID
NCT02935868
Collaborator
(none)
30
1
34
0.9

Study Details

Study Description

Brief Summary

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 incidence of type 1 diabetes in younger patients. Thus, the aim of this observational study was to evaluate the periodontal and salivary condition of a sample of patients with type 1 diabetes of a brazillian city.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    30 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    Official Title:
    Periodontal and Salivary Evaluation of a Sample of Type 1 Diabetes Mellitus Patients in Brazil
    Study Start Date :
    Nov 1, 2013
    Actual Primary Completion Date :
    Sep 1, 2016
    Actual Study Completion Date :
    Sep 1, 2016

    Arms and Interventions

    Arm Intervention/Treatment
    Test group

    Patients with Type 1 diabetes mellitus

    Control Group

    Patients without systemic diseases

    Outcome Measures

    Primary Outcome Measures

    1. Periodontal disease (gingivitis and periodontitis) measured by a periodontal probe and classified according to severity [one day]

      Severe periodontitis was defined by the presence of ≥ 2 interproximal sites in different teeth with CAL (clinical attachment level) ≥ 6mm and ≥1 interproximal site with PPD (periodontal probing depth) ≥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/BOP (bleeding on probing) extent scores < 10% and with gingivitis if presented PPD ≤3mm/ BOP extent scores >10%.

    2. Salivary pH and buffering Capacity - collection of stimulated saliva in 10 minutes and measurement of acidity with a pHmeter [one day]

      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''

    3. Salivary glucose - collection of stimulated saliva in 10 minutes and measurement with a colorimetric kit [one day]

      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.

    4. Salivary peroxidase - collection of stimulated saliva in 10 minutes, measurement by a spectrophotometer. [one day]

      The activity of salivary peroxidase is presented in Units/mg. The detection of activity of these enzymes is associated to periodontal disease.

    Secondary Outcome Measures

    1. Plaque index - measured by visual observation and classification in scores (1 for presence, 0 for absence) [One day]

      Plaque index (PI) will be registered as scores (1 for presence, 0 for absence). For control group a plaque index of 15% is considered normal.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 35 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Diagnose of Type 1 diabetes mellitus

    • Age between 18 and 35 years old

    • Presenting on tooth per quadrant

    Exclusion Criteria:
    • Diagnose of Type 2 diabetes mellitus

    • Edentulous patients

    • Other systemic diseases

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Bauru School of Dentistry Bauru Sao Paulo Brazil 17012-901

    Sponsors and Collaborators

    • University of Sao Paulo

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Carla Andreotti Damante, Associate professor, University of Sao Paulo
    ClinicalTrials.gov Identifier:
    NCT02935868
    Other Study ID Numbers:
    • Bauru School of Dentistry
    First Posted:
    Oct 18, 2016
    Last Update Posted:
    Oct 18, 2016
    Last Verified:
    Oct 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Carla Andreotti Damante, Associate professor, University of Sao Paulo
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 18, 2016