NCT02935868

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

November 1, 2013

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

September 29, 2016

Completed
19 days until next milestone

First Posted

Study publicly available on registry

October 18, 2016

Completed
Last Updated

October 18, 2016

Status Verified

October 1, 2016

Enrollment Period

2.8 years

First QC Date

September 29, 2016

Last Update Submit

October 13, 2016

Conditions

Diabetes Mellitus, Type 1Periodontal Diseases

Keywords

Saliva

Outcome Measures

Primary Outcomes (4)

  • 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 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%.

    one day

  • 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''

    one day

  • Salivary glucose - collection of stimulated saliva in 10 minutes and measurement 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.

    one day

  • Salivary peroxidase - collection of stimulated saliva in 10 minutes, measurement by a spectrophotometer.

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

    one day

Secondary Outcomes (1)

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

    One day

Study Arms (2)

Test group

Patients with Type 1 diabetes mellitus

Control Group

Patients without systemic diseases

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Test Group: Patients diagnosed with Type 1 diabetes mellitus

You may qualify if:

  • Diagnose of Type 1 diabetes mellitus
  • Age between 18 and 35 years old
  • Presenting on tooth per quadrant

You may not qualify if:

  • Diagnose of Type 2 diabetes mellitus
  • Edentulous patients
  • Other systemic diseases

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)

  • Aren G, Sepet E, Ozdemir D, Dinccag N, Guvener B, Firatli E. Periodontal health, salivary status, and metabolic control in children with type 1 diabetes mellitus. J Periodontol. 2003 Dec;74(12):1789-95. doi: 10.1902/jop.2003.74.12.1789.

    PMID: 14974821BACKGROUND

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Periodontal Diseases

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

September 29, 2016

First Posted

October 18, 2016

Study Start

November 1, 2013

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

October 18, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)