Impact of Periodontal Therapy on Patients With Diabetes (NCT04830969) | Clinical Trial Compass
CompletedPhase 2
Impact of Periodontal Therapy on Patients With Diabetes
United States116 participantsStarted 2016-11-08
Plain-language 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.
Who can participate
Age range25 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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.
What they're measuring
1
Change in Probing Pocket Depth at the 6-month Post-SRP Completed at Baseline