Clinical trial NCT04830969: Impact of Periodontal Therapy on Patients With Diabetes
Official title: Impact of Periodontal Therapy on Patients With Diabetes: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus, Type II
Periodontitis
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
Collaborators: name: Sunstar, Inc.
First posted: 2021-04-05
Enrollment: 116
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

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.

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.

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.

Primary outcomes:
measure: Change in Probing Pocket Depth at the 6-month Post-SRP Completed at Baseline
timeFrame: Baseline to 6 months
Secondary outcomes:
measure: Change in Probing Pocket Depth at the 3-month Post-SRP Completed at Baseline
timeFrame: Baseline to 3 months
measure: Changes in Clinical Attachment Level at 3, 6 Months After Treatment at Baseline
timeFrame: Baseline to 3 months;Baseline to 6 months
measure: Change in % Sites With Probing Pocket Depth >= 4 mm of a Participant at the 3, 6 Months Post-SRP Completed at Baseline
timeFrame: Baseline to 3 months; Baseline to 6 months
measure: Changes in Bleeding on Probing (BOP) Index of a Participant at 3, 6 Months After Treatment at Baseline
timeFrame: Baseline to 3 months; Baseline to 6 months
measure: Change in Plaque Index of a Participant at 3, 6 Months After Treatment at Baseline
timeFrame: Baseline to 3 months; Baseline to 6 months
measure: Change in Probing Pocket Depth at 3, 6 Months After Treatment in Diabetics and Non-diabetics
timeFrame: Baseline to 3 months; Baseline to 6 months
measure: Changes in Clinical Attachment Level at 3, 6 Months After Treatment at Baseline in Diabetics and Non-diabetics
timeFrame: Baseline to 3 months; Baseline to 6 months
measure: 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
timeFrame: Baseline to 3 months; Baseline to 6 months
measure: Changes in Bleeding on Probing (BOP) Index of a Participant at 3, 6 Months After Treatment at Baseline in Diabetics and Non-diabetics
timeFrame: Baseline to 3 months; Baseline to 6 months
measure: Change in Plaque Index of a Participant at 3, 6 Months After Treatment at Baseline in Diabetics and Non-diabetics
timeFrame: Baseline to 3 months; Baseline to 6 months
measure: Changes in Hemoglobin A1c at 6 Months After Treatment
timeFrame: Baseline to 6 months
measure: Changes in Fasting Blood Glucose at 6 Months After Treatment
timeFrame: Baseline to 6 months
measure: Change in High Sensitivity C-reactive Protein at 6 Months After Treatment
timeFrame: Baseline to 6 months
measure: Changes in Hemoglobin A1c at 6 Months After Treatment in Diabetics and Non-diabetics
timeFrame: Baseline to 6 months
measure: Changes in Fasting Blood Glucose at 6 Months After Treatment in Diabetics and Non-diabetics
timeFrame: Baseline to 6 months
measure: Change in High Sensitivity C-reactive Protein at 6 Months After Treatment in Diabetics and Non-diabetics
timeFrame: Baseline to 6 months
measure: Shannon Index of the Subgingival Plaque Microbiome at Baseline and 6 Months
timeFrame: Baseline; 6 Months
measure: Change in Distance to the Healthy Plane Based on the Subgingival Plaque Microbiome at 6 Months
timeFrame: Baseline to 6 Months
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: University at Buffalo
state: New York
Study officials:
affiliation: University at Buffalo, State University of New York
name: Robert E Schifferle, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
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