Impact of Periodontal Therapy on Patients With Diabetes

• Status: Completed
• Trial end date: 2021-01-28
• Target enrollment: 0
• Participant gender: All

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 efficacy of periodontal therapy in diabetics and fewer that include evaluation of the oral microbial profiles (the microbiome). The investigators will examine systemic changes in diabetes status and microbiome influences on clinical response to periodontal therapy in a randomized clinical trial of participants with and without diabetes and with periodontal disease. Two different treatments will be used:

1. Scaling and root planning (SRP) alone, or

2. SRP and supportive periodontal therapy (SPT), the use of chlorhexidine gluconate rinse (Paroex®) and a rubber interdental bristle cleaner (Soft-Picks) The main goal of this clinical trial is to evaluate the effects of SRP alone versus SRP+SPT on clinical, microbiological and immunological status in participants. A clearer understanding of how periodontal therapy affects diabetes status could lead to the development of new therapies for periodontal disease and diabetes.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: State University of New York at Buffalo
• Collaborator: Sunstar, Inc.
• Treatments: Chlorhexidine; Chlorhexidine gluconate

Criteria

Inclusion Criteria:

1. Be able to understand the informed consent form and be willing and able to read and sign it.

2. At least 25 years of age.

3. Be able to understand and follow directions for study procedures.

4. At least 14 natural teeth, not counting third molars ("wisdom teeth").

5. At least 2 interproximal sites with CAL >= 4 mm or at least 2 interproximal sites with PD >= 5 mm.

Exclusion Criteria:

1. Presence of orthodontic appliances ("braces").

2. 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.

3. Abscess of the gingiva caused by periodontal disease, or visible gross tooth decay

4. A broken tooth root or an abscessed tooth. Subject may be allowed to participate in the study after the condition is successfully treated.

5. Periodontal treatment or antibiotic therapy in the past 6 months.

6. Have used cigarettes or other tobacco products in the past year.

7. Body mass index (BMI) is > 40.

8. Have regularly used non-steroidal anti-inflammatory drugs (such as >= 325 mg aspirin or ibuprofen) over the past 3 weeks.

9. Regularly using drugs that weaken the immune system (such as corticosteroids taken by mouth or injection, and cyclosporine).

10. Have participated in another clinical research study in the past 30 days.

11. Pregnant or breastfeeding.

12. Have a condition that we feel will make study participation unsafe or difficult for the patient.

13. Require premedication for dental exams.