Impact of Periodontal Therapy on Patients With Diabetes
Condition: Diabetes Mellitus, Type II; Periodontitis
MeSH terms: Periodontitis; Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Chlorhexidine gluconate oral rinse; Scaling & Root Planing; Soft Picks
Intervention description: Paroex® is a non-alcohol chlorhexidine preparation. Participants are to use 15 mL morning and evening for 3 months. With use of chlorhexidine, there is risk of reversible staining of teeth and the possibility of some alteration in taste. There is increased likeliness of staining in smokers, coffee drinkers and those who are susceptible to teeth staining in general. The cleaning of the front teeth is provided at the 3-month visit and helps to reduce any staining that may occur. If there is any alteration in taste, it should go away when use of chlorhexidine stops.; SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums.; Soft Picks are a rubber interdental bristle cleaner. Participants are to use Soft Picks morning and evening for all 12 months of the study. They may cause some bleeding of the gums at first usage, but the bleeding should lessen and stop as use is continued (as gums heal). Soft-Picks are a readily available consumer product sold in supermarkets and drug stores.
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Enrollment: 116.0
Sex: All
Minimum age: 25 Years
Healthy volunteers: No

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.
    

Eligibility 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.