Impact of Periodontal Therapy on Patients With Diabetes

Phase 2

Completed

Conditions: Diabetes Mellitus, Type II
Periodontitis

Interventions: Drug: Chlorhexidine gluconate oral rinse
Procedure: Scaling & Root Planing
Device: Soft Picks

Registration Number: NCT04830969

Lead Sponsor: State University of New York at Buffalo

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 116

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 > 40.
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.
Pregnant or breastfeeding.
Have a condition that we feel will make study participation unsafe or difficult for the patient.
Require premedication for dental exams.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A: Diabetic + SRP + SPT	Scaling & Root Planing	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.
A: Diabetic + SRP + SPT	Soft Picks	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.
B: Non-Diabetic + SRP + SPT	Scaling & Root Planing	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.
B: Non-Diabetic + SRP + SPT	Soft Picks	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.
C: Diabetic + SRP	Scaling & Root Planing	The third group, C, includes diabetics with periodontal disease; they will receive standard therapy, scaling and root planing (SRP).
D: Non-Diabetic + SRP	Scaling & Root Planing	The second group, D, includes non-diabetics with periodontal disease; they will receive standard therapy, scaling and root planing (SRP).
A: Diabetic + SRP + SPT	Chlorhexidine gluconate oral rinse	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.
B: Non-Diabetic + SRP + SPT	Chlorhexidine gluconate oral rinse	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.

Primary Outcome Measures

Name	Time	Method
Change in Probing Pocket Depth at the 6-month Post-SRP Completed at Baseline	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 Outcome Measures

Name	Time	Method
Change in Probing Pocket Depth at 3, 6 Months After Treatment in Diabetics and Non-diabetics	Baseline to 3 months; Baseline to 6 months	Probing depth (PD) or probing pocket depth (PPD), measured on six surfaces/tooth, is the distance in millimeters (mm) from the gingival margin to the base of the gingival pocket
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	The analysis is based on the measures of each participant. Plaque is visually measured on 6 sites per tooth; 0 is the absence of any plaque. 1 is the presence of plaque. For each participant, 6 sites per tooth are evaluated. The Plaque Index (PI) of each participant is defined as the percentage of sites with plaque. The value of PI ranges from 0 to 100 for each participant. The PI of each participant is assessed and compared between measured time points.
Change in Probing Pocket Depth at the 3-month Post-SRP Completed at Baseline	Baseline to 3 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
Change in Plaque Index of a Participant at 3, 6 Months After Treatment at Baseline	Baseline to 3 months; Baseline to 6 months	The analysis is based on the measures of each participant. Plaque is visually measured on 6 sites per tooth; 0 is the absence of any plaque. 1 is the presence of plaque. For each participant, 6 sites per tooth are evaluated. The Plaque Index (PI) of each participant is defined as the percentage of sites with plaque. The value of PI ranges from 0 to 100 for each participant. The PI of each participant is assessed and compared between measured time points.
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	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.
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	The analysis is based on the measure of each 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 per participant is compared between measured time points.
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	The analysis is based on the measures of each participant. 0 is the absence of gingival bleeding and 1 is the presence of gingival bleeding after probing and measuring for pocket depth. Bleeding on probing index is defined as the percentage of sites with presence of gingival bleeding after probing per participant. The value of bleeding on probing index ranges from 0 to 100 for each participant. The bleeding on probing index per participant is compared between time points measured.
Changes in Clinical Attachment Level at 3, 6 Months After Treatment at Baseline	Baseline to 3 months;Baseline to 6 months	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.
Changes in Fasting Blood Glucose at 6 Months After Treatment	Baseline to 6 months	Fasting blood sugar/glucose (FBS/FBG) is tested with a blood sample taken after an overnight fast. A fasting blood sugar level less than 100 mg/dL is normal; a fasting blood sugar level from 100 to 125 mg/dL is considered prediabetes; a level 126 mg/dL (7 mmol/L) or higher on two separate tests, indicates diabetes.
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	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.
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	The analysis is based on the measures of each participant. 0 is the absence of gingival bleeding and 1 is the presence of gingival bleeding after probing and measuring for pocket depth. Bleeding on probing index is defined as the percentage of sites with presence of gingival bleeding after probing per participant. The value of bleeding on probing index ranges from 0 to 100 for each participant. The bleeding on probing index per participant is compared between time points measured.
Changes in Hemoglobin A1c at 6 Months After Treatment	Baseline to 6 months	Hemoglobin in A1c (HbA1c) tells the average level of blood sugar over the prior 2 to 3 months. Normal level is below 5.7%; 5.7%-6.4% indicates prediabetes; greater than 6.5% is indicative of diabetes.
Change in High Sensitivity C-reactive Protein at 6 Months After Treatment	Baseline to 6 months	The high-sensitivity C-reactive protein (hs-CRP) blood test measures body inflammation indicating infection or a chronic inflammatory disease such as periodontitis or diabetes. It also can be used to evaluate risk of developing coronary artery disease. A normal reading is less than 10 milligram per liter (mg/L); a level greater than 10 mg/L is a sign of serious infection, trauma or chronic disease likely requiring further testing to determine cause
Changes in Hemoglobin A1c at 6 Months After Treatment in Diabetics and Non-diabetics	Baseline to 6 months	Hemoglobin in A1c (HbA1c) tells the average level of blood sugar over the prior 2 to 3 months. Normal level is below 5.7%; 5.7%-6.4% indicates prediabetes; greater than 6.5% is indicative of diabetes.
Changes in Fasting Blood Glucose at 6 Months After Treatment in Diabetics and Non-diabetics	Baseline to 6 months	Fasting blood sugar/glucose (FBS/FBG) is tested with a blood sample taken after an overnight fast. A fasting blood sugar level less than 100 mg/dL is normal; a fasting blood sugar level from 100 to 125 mg/dL is considered prediabetes; a level 126 mg/dL (7 mmol/L) or higher on two separate tests, indicates diabetes.
Change in High Sensitivity C-reactive Protein at 6 Months After Treatment in Diabetics and Non-diabetics	Baseline to 6 months	The high-sensitivity C-reactive protein (hs-CRP) blood test measures body inflammation indicating infection or a chronic inflammatory disease such as periodontitis or diabetes. It also can be used to evaluate risk of developing coronary artery disease. A normal reading is less than 10 milligram per liter (mg/L); a level greater than 10 mg/L is a sign of serious infection, trauma or chronic disease likely requiring further testing to determine cause
Shannon Index of the Subgingival Plaque Microbiome at Baseline and 6 Months	Baseline; 6 Months	Shannon index represents mean species diversity in a site at a local scale. Shannon index quantifies the uncertainty in predicting the species identity of an individual that is taken at random from the dataset. The minimum value is 0 and there is no maximum value. High values mean high species diversities.
Change in Distance to the Healthy Plane Based on the Subgingival Plaque Microbiome at 6 Months	Baseline to 6 Months	Analysis of microbiome community changes using the healthy plane (HP) as a reference. A healthy plane was calculated by fitting a plane that minimizes the sum of squares of distances from HC samples to the nearest point on the plane. The distance of each sample to the HP was then calculated. Higher values of distance to HP mean microbiome community changes towards disease status