Status:
COMPLETED
Impact of Periodontal Therapy on Patients With Diabetes
Lead Sponsor:
State University of New York at Buffalo
Collaborating Sponsors:
Sunstar, Inc.
Conditions:
Diabetes Mellitus, Type II
Periodontitis
Eligibility:
All Genders
25+ years
Phase:
PHASE2
Brief Summary
With poorly controlled diabetes, periodontal status often worsens, and with severe periodontal conditions there is often poorer glycemic control. There are few published reports investigating the effi...
Detailed Description
With poorly controlled diabetes, periodontal disease worsens, and with severe periodontal conditions, there is often poorer glycemic control. Published papers conclude that periodontal treatment leads...
Eligibility Criteria
Inclusion
- Be able to understand the informed consent form and be willing and able to read and sign it.
- At least 25 years of age.
- Be able to understand and follow directions for study procedures.
- At least 14 natural teeth, not counting third molars ("wisdom teeth").
- At least 2 interproximal sites with CAL \>= 4 mm or at least 2 interproximal sites with PD \>= 5 mm.
Exclusion
- Presence of orthodontic appliances ("braces").
- An abnormal condition of lips, lining of the mouth, tongue, or gums (except for periodontal disease). If subject has a cold sore, canker sore, or injury in their mouth, they may return after the sore or injury heals.
- Abscess of the gingiva caused by periodontal disease, or visible gross tooth decay
- A broken tooth root or an abscessed tooth. Subject may be allowed to participate in the study after the condition is successfully treated.
- Periodontal treatment or antibiotic therapy in the past 6 months.
- Have used cigarettes or other tobacco products in the past year.
- Body mass index (BMI) is \> 40.
- Have regularly used non-steroidal anti-inflammatory drugs (such as \>= 325 mg aspirin or ibuprofen) over the past 3 weeks.
- Regularly using drugs that weaken the immune system (such as corticosteroids taken by mouth or injection, and cyclosporine).
- Have participated in another clinical research study in the past 30 days.
- Pregnant or breastfeeding.
- Have a condition that we feel will make study participation unsafe or difficult for the patient.
- Require premedication for dental exams.
Key Trial Info
Start Date :
November 8 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 28 2021
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT04830969
Start Date
November 8 2016
End Date
January 28 2021
Last Update
March 1 2023
Active Locations (1)
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1
University at Buffalo
Buffalo, New York, United States, 14214