Periodontal and Salivary Evaluation of Type 1 Diabetes Mellitus Patients

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02935868
• Other study ID #: Bauru School of Dentistry
• Status: Completed
• Phase: N/A
• First received: September 29, 2016
• Last updated: October 13, 2016
• Start date: November 2013
• Est. completion date: September 2016

Study information

• Verified date: October 2016
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Gingival Diseases
• Periodontal Diseases

Locations

Country	Name	City	State
Brazil	Bauru School of Dentistry	Bauru	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

Aren G, Sepet E, Ozdemir D, Dinççag N, Güvener 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	Plaque index - measured by visual observation and classification in scores (1 for presence, 0 for absence)	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.	One day	No

External Links

•   Master Thesis in Portuguese - abstract in english