Impact of Periodontal Therapy on Patients With Diabetes: A Pilot Study
Overview
- Phase
- Phase 2
- Intervention
- Chlorhexidine gluconate oral rinse
- Conditions
- Diabetes Mellitus, Type II
- Sponsor
- State University of New York at Buffalo
- Enrollment
- 116
- Locations
- 1
- Primary Endpoint
- Change in Probing Pocket Depth at the 6-month Post-SRP Completed at Baseline
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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 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:
- Scaling and root planning (SRP) alone, or
- 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.
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 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.
Investigators
Robert Schifferle, DDS, PhD
Principal Investigator
State University of New York at Buffalo
Eligibility Criteria
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.
- •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 \>
- •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.
Arms & Interventions
A: Diabetic + SRP + SPT
The first group, A, includes diabetics with periodontal disease; they will receive standard therapy, scaling \& root planing plus supportive periodontal therapy (SPT) chlorhexidine gluconate (Paroex®) mouthrinse + Soft-Picks.
Intervention: Chlorhexidine gluconate oral rinse
A: Diabetic + SRP + SPT
The first group, A, includes diabetics with periodontal disease; they will receive standard therapy, scaling \& root planing plus supportive periodontal therapy (SPT) chlorhexidine gluconate (Paroex®) mouthrinse + Soft-Picks.
Intervention: Scaling & Root Planing
A: Diabetic + SRP + SPT
The first group, A, includes diabetics with periodontal disease; they will receive standard therapy, scaling \& root planing plus supportive periodontal therapy (SPT) chlorhexidine gluconate (Paroex®) mouthrinse + Soft-Picks.
Intervention: Soft Picks
B: Non-Diabetic + SRP + SPT
The second group, B, includes non-diabetics with periodontal disease; they will receive standard therapy, scaling \& root planing plus supportive periodontal therapy (SPT) chlorhexidine gluconate (Paroex®) mouthrinse + Soft-Picks.
Intervention: Chlorhexidine gluconate oral rinse
B: Non-Diabetic + SRP + SPT
The second group, B, includes non-diabetics with periodontal disease; they will receive standard therapy, scaling \& root planing plus supportive periodontal therapy (SPT) chlorhexidine gluconate (Paroex®) mouthrinse + Soft-Picks.
Intervention: Scaling & Root Planing
B: Non-Diabetic + SRP + SPT
The second group, B, includes non-diabetics with periodontal disease; they will receive standard therapy, scaling \& root planing plus supportive periodontal therapy (SPT) chlorhexidine gluconate (Paroex®) mouthrinse + Soft-Picks.
Intervention: Soft Picks
C: Diabetic + SRP
The third group, C, includes diabetics with periodontal disease; they will receive standard therapy, scaling and root planing (SRP).
Intervention: Scaling & Root Planing
D: Non-Diabetic + SRP
The second group, D, includes non-diabetics with periodontal disease; they will receive standard therapy, scaling and root planing (SRP).
Intervention: Scaling & Root Planing
Outcomes
Primary Outcomes
Change in Probing Pocket Depth at the 6-month Post-SRP Completed at Baseline
Time Frame: Baseline to 6 months
Periodontal PD in millimeters is measured with a UNC-15 periodontal probe on 6 sites per tooth; site status is compared between timepoints measured
Secondary Outcomes
- Change in Probing Pocket Depth at 3, 6 Months After Treatment in Diabetics and Non-diabetics(Baseline to 3 months; Baseline to 6 months)
- Change in Plaque Index of a Participant at 3, 6 Months After Treatment at Baseline in Diabetics and Non-diabetics(Baseline to 3 months; Baseline to 6 months)
- Change in Probing Pocket Depth at the 3-month Post-SRP Completed at Baseline(Baseline to 3 months)
- Change in Plaque Index of a Participant at 3, 6 Months After Treatment at Baseline(Baseline to 3 months; Baseline to 6 months)
- Changes in Clinical Attachment Level at 3, 6 Months After Treatment at Baseline in Diabetics and Non-diabetics(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 in Diabetics and Non-diabetics(Baseline to 3 months; Baseline to 6 months)
- Changes in Bleeding on Probing (BOP) Index of a Participant at 3, 6 Months After Treatment at Baseline in Diabetics and Non-diabetics(Baseline to 3 months; Baseline to 6 months)
- Changes in Clinical Attachment Level at 3, 6 Months After Treatment at Baseline(Baseline to 3 months;Baseline to 6 months)
- Changes in Fasting Blood Glucose at 6 Months After Treatment(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(Baseline to 3 months; Baseline to 6 months)
- Changes in Bleeding on Probing (BOP) Index of a Participant at 3, 6 Months After Treatment at Baseline(Baseline to 3 months; Baseline to 6 months)
- Changes in Hemoglobin A1c at 6 Months After Treatment(Baseline to 6 months)
- Change in High Sensitivity C-reactive Protein at 6 Months After Treatment(Baseline to 6 months)
- Changes in Hemoglobin A1c at 6 Months After Treatment in Diabetics and Non-diabetics(Baseline to 6 months)
- Changes in Fasting Blood Glucose at 6 Months After Treatment in Diabetics and Non-diabetics(Baseline to 6 months)
- Change in High Sensitivity C-reactive Protein at 6 Months After Treatment in Diabetics and Non-diabetics(Baseline to 6 months)
- Shannon Index of the Subgingival Plaque Microbiome at Baseline and 6 Months(Baseline; 6 Months)
- Change in Distance to the Healthy Plane Based on the Subgingival Plaque Microbiome at 6 Months(Baseline to 6 Months)