Status:
COMPLETED
Periodontal Treatment Response in Type II Diabetic Patients
Lead Sponsor:
University of Florida
Collaborating Sponsors:
Colgate Palmolive
Conditions:
Type II Diabetes
Periodontal Disease
Eligibility:
All Genders
18-70 years
Brief Summary
Diabetes mellitus affects \> 171 million people worldwide, with type II diabetes being the most prevalent, affecting 85-95% of the diabetic population. Unfortunately, despite conventional medical trea...
Detailed Description
Many studies have shown a relationship between chronic inflammatory periodontal diseases and diabetes, in which both diseases influence the other. Research studies have shown that controlling inflamma...
Eligibility Criteria
Inclusion
- Subject males or females 18 to 70 years old
- Subject able and willing to follow study procedures and instructions
- Subject read, understood and signed an informed consent form
- Subject diagnosed with type II diabetes
- Currently under standard treatment and physicians care for diabetes control
- Standard diabetes medication has not changed in the last 3 months
- HbA1c levels of ≥ 6.5% determined upon medical record review within the last 6 months (if HbA1c value not available in medical record or if patient is new, the first study visit value will determine if patient may continue in the study)
Exclusion
- Subject with concomitant periodontal therapy 6 months prior to enrollment
- Subject with orthodontic appliances
- Subject chronically treated (i.e., two weeks or more) with any medication known to affect inflammation or periodontal status or (e.g.phenytoin, cyclosporine, Coumadin or steroids) within one month of the first examination\*
- Subject currently smoke or who report smoking within one year of first examination ≥ 10 cigarettes/day
- Subject treated with antibiotics within 3 months prior to enrollment
- Subject necessitating antibiotic prophylaxis
- Female subject who report being pregnant or lactating at first appointment
- Subject uses hormonal contraceptives but started method less than 30 days prior to the first examination
- Subject with active infectious diseases (hepatitis, human immunodeficiency virus or Tuberculosis) or subject is immunocompromised as determined by the Investigator
- Subjects has a medical condition which precludes not eating/drinking for approximately 8 hours
- Subject has serious diabetic complications such as macrovascular diseases or kidney or liver failure
- Subjects who have a known allergy to oral care products or ingredients in oral care products
Key Trial Info
Start Date :
June 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT01881074
Start Date
June 1 2012
End Date
December 1 2015
Last Update
September 17 2018
Active Locations (1)
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1
University of Florida
Gainesville, Florida, United States, 32610