Impact of Periodontal Therapy on Patients With Diabetes

State University of New York at Buffalo116 enrolled

Overview

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.

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 to a reduction in hemoglobin A1c; however, other studies show limited or no improvement. Some patients do not respond well to professional periodontal therapy, even without diabetes, which could be related to poor oral hygiene and/or host factors including microbial profiles. There are few published papers investigating the efficacy of periodontal therapy in diabetics and fewer that include assessment of the oral microbiome. The investigators will examine systemic changes in diabetes status and microbiome influences on clinical response to periodontal therapy in a randomized clinical trial. It has been shown that chlorhexidine gluconate rinse leads to significant clinical improvement over standard periodontal therapy alone, and interdental tooth cleaners remove more dental plaque (leading to reduced gingival inflammation) effectively than brushing alone. Therefore, in this study, standard periodontal therapy, scaling and root planning (SRP) will be provided alone, or SRP plus supportive periodontal therapy (SPT), the use of chlorhexidine gluconate rinse (Paroex®) and a rubber interdental bristle cleaner (Soft-Picks), to diabetics and non-diabetics with periodontal disease to determine the differences in response between the groups. The main aim of this study is to evaluate the effects of SRP alone versus SRP+SPT on clinical, microbiological and immunological status of subjects with and without type 2 diabetes and with periodontal disease. A clearer understanding of how periodontal therapy affects diabetes status could lead to the development of novel new targeted therapies of both periodontal disease and diabetes.

Interventions

Chlorhexidine gluconate oral rinseDRUG

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.

Scaling & Root PlaningPROCEDURE

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 PicksDEVICE

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.

Eligibility

Sex: ALLMin age: 25 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Change in Probing Pocket Depth at the 6-month Post-SRP Completed at Baseline

Periodontal PD in millimeters is measured with a UNC-15 periodontal probe on 6 sites per tooth; site status is compared between timepoints measured

Time frame: Baseline to 6 months

Secondary Outcomes

Change in Probing Pocket Depth at the 3-month Post-SRP Completed at Baseline

Periodontal PD in millimeters is measured with a UNC-15 periodontal probe on 6 sites per tooth; site status is compared between timepoints measured

Time frame: Baseline to 3 months

Changes in Clinical Attachment Level at 3, 6 Months After Treatment at Baseline

The distance from the Cemento-enamel Junction (CEJ) to the free gingival margin is measured with a periodontal probe. Millimeters of recession (loss of attachment) is recorded as a negative number; when the gingival margin is above the CEJ, the measurement (in millimeters) is recorded as positive.

Time frame: Baseline to 3 months;Baseline to 6 months

Change in % Sites With Probing Pocket Depth >= 4 mm of a Participant at the 3, 6 Months Post-SRP Completed at Baseline

The analysis is based on the measures of each participant. Participant instead of site is used as unite for arm/group. The measure, % sites with probing pocket depth \>= 4 mm within each participant, indicates the portion of deep pocket in a participant. Periodontal PD in millimeters is measured with a UNC-15 periodontal probe on 6 sites per tooth; The percentage of sites with Periodontal PD \>= 4 mm within each participant was compared between measured time points.