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Completed

NCT Number: NCT02935868

Periodontal and Salivary Evaluation of Type 1 Diabetes Mellitus Patients

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.

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Key information

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Bauru School of Dentistry

Bauru, São Paulo, 17012-901, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: 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

    Time frame: 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

    Time frame: 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.

    Time frame: 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 outcomes

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

Periodontal and Salivary Evaluation of a Sample of Type 1 Diabetes Mellitus Patients in Brazil

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Oct 18, 2016
Registry last updated
Oct 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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