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Impact of Periodontal Therapy on Patients With Diabetes (DMRCT)

Primary Purpose

Diabetes Mellitus, Type II, Periodontitis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Chlorhexidine gluconate oral rinse
Scaling & Root Planing
Soft Picks
Sponsored by
State University of New York at Buffalo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type II

Eligibility Criteria

25 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University at Buffalo

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Active Comparator

Arm Label

A: Diabetic + SRP + SPT

B: Non-Diabetic + SRP + SPT

C: Diabetic + SRP

D: Non-Diabetic + SRP

Arm Description

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.

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.

The third group, C, includes diabetics with periodontal disease; they will receive standard therapy, scaling and root planing (SRP).

The second group, D, includes non-diabetics with periodontal disease; they will receive standard therapy, scaling and root planing (SRP).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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.
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.
Changes in Bleeding on Probing (BOP) Index of a Participant at 3, 6 Months After Treatment at Baseline
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.
Change in Plaque Index of a Participant at 3, 6 Months After Treatment at Baseline
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 3, 6 Months After Treatment in Diabetics and Non-diabetics
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
Changes in Clinical Attachment Level at 3, 6 Months After Treatment at Baseline in Diabetics and Non-diabetics
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
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
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.
Change in Plaque Index of a Participant at 3, 6 Months After Treatment at Baseline in Diabetics and Non-diabetics
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 Hemoglobin A1c at 6 Months After Treatment
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
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
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
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
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
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
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
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

Full Information

First Posted
March 31, 2021
Last Updated
January 30, 2023
Sponsor
State University of New York at Buffalo
Collaborators
Sunstar, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04830969
Brief Title
Impact of Periodontal Therapy on Patients With Diabetes
Acronym
DMRCT
Official Title
Impact of Periodontal Therapy on Patients With Diabetes: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
November 8, 2016 (Actual)
Primary Completion Date
January 28, 2021 (Actual)
Study Completion Date
January 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State University of New York at Buffalo
Collaborators
Sunstar, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type II, Periodontitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
116 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A: Diabetic + SRP + SPT
Arm Type
Experimental
Arm Description
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.
Arm Title
B: Non-Diabetic + SRP + SPT
Arm Type
Experimental
Arm Description
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.
Arm Title
C: Diabetic + SRP
Arm Type
Active Comparator
Arm Description
The third group, C, includes diabetics with periodontal disease; they will receive standard therapy, scaling and root planing (SRP).
Arm Title
D: Non-Diabetic + SRP
Arm Type
Active Comparator
Arm Description
The second group, D, includes non-diabetics with periodontal disease; they will receive standard therapy, scaling and root planing (SRP).
Intervention Type
Drug
Intervention Name(s)
Chlorhexidine gluconate oral rinse
Other Intervention Name(s)
Paroex
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.
Intervention Type
Procedure
Intervention Name(s)
Scaling & Root Planing
Other Intervention Name(s)
SRP
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Soft Picks
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Probing Pocket Depth at the 6-month Post-SRP Completed at Baseline
Description
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 Outcome Measure Information:
Title
Change in Probing Pocket Depth at the 3-month Post-SRP Completed at Baseline
Description
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
Title
Changes in Clinical Attachment Level at 3, 6 Months After Treatment at Baseline
Description
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
Title
Change in % Sites With Probing Pocket Depth >= 4 mm of a Participant at the 3, 6 Months Post-SRP Completed at Baseline
Description
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.
Time Frame
Baseline to 3 months; Baseline to 6 months
Title
Changes in Bleeding on Probing (BOP) Index of a Participant at 3, 6 Months After Treatment at Baseline
Description
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.
Time Frame
Baseline to 3 months; Baseline to 6 months
Title
Change in Plaque Index of a Participant at 3, 6 Months After Treatment at Baseline
Description
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.
Time Frame
Baseline to 3 months; Baseline to 6 months
Title
Change in Probing Pocket Depth at 3, 6 Months After Treatment in Diabetics and Non-diabetics
Description
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
Time Frame
Baseline to 3 months; Baseline to 6 months
Title
Changes in Clinical Attachment Level at 3, 6 Months After Treatment at Baseline in Diabetics and Non-diabetics
Description
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
Title
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
Description
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.
Time Frame
Baseline to 3 months; Baseline to 6 months
Title
Changes in Bleeding on Probing (BOP) Index of a Participant at 3, 6 Months After Treatment at Baseline in Diabetics and Non-diabetics
Description
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.
Time Frame
Baseline to 3 months; Baseline to 6 months
Title
Change in Plaque Index of a Participant at 3, 6 Months After Treatment at Baseline in Diabetics and Non-diabetics
Description
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.
Time Frame
Baseline to 3 months; Baseline to 6 months
Title
Changes in Hemoglobin A1c at 6 Months After Treatment
Description
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.
Time Frame
Baseline to 6 months
Title
Changes in Fasting Blood Glucose at 6 Months After Treatment
Description
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.
Time Frame
Baseline to 6 months
Title
Change in High Sensitivity C-reactive Protein at 6 Months After Treatment
Description
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
Time Frame
Baseline to 6 months
Title
Changes in Hemoglobin A1c at 6 Months After Treatment in Diabetics and Non-diabetics
Description
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.
Time Frame
Baseline to 6 months
Title
Changes in Fasting Blood Glucose at 6 Months After Treatment in Diabetics and Non-diabetics
Description
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.
Time Frame
Baseline to 6 months
Title
Change in High Sensitivity C-reactive Protein at 6 Months After Treatment in Diabetics and Non-diabetics
Description
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
Time Frame
Baseline to 6 months
Title
Shannon Index of the Subgingival Plaque Microbiome at Baseline and 6 Months
Description
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.
Time Frame
Baseline; 6 Months
Title
Change in Distance to the Healthy Plane Based on the Subgingival Plaque Microbiome at 6 Months
Description
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
Time Frame
Baseline to 6 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
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 > 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert E Schifferle, DDS, PhD
Organizational Affiliation
University at Buffalo, State University of New York
Official's Role
Principal Investigator
Facility Information:
Facility Name
University at Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14214
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
2209317
Citation
Nelson RG, Shlossman M, Budding LM, Pettitt DJ, Saad MF, Genco RJ, Knowler WC. Periodontal disease and NIDDM in Pima Indians. Diabetes Care. 1990 Aug;13(8):836-40. doi: 10.2337/diacare.13.8.836.
Results Reference
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PubMed Identifier
9527565
Citation
Taylor GW, Burt BA, Becker MP, Genco RJ, Shlossman M, Knowler WC, Pettitt DJ. Non-insulin dependent diabetes mellitus and alveolar bone loss progression over 2 years. J Periodontol. 1998 Jan;69(1):76-83. doi: 10.1902/jop.1998.69.1.76.
Results Reference
background
PubMed Identifier
24708451
Citation
Arora N, Papapanou PN, Rosenbaum M, Jacobs DR Jr, Desvarieux M, Demmer RT. Periodontal infection, impaired fasting glucose and impaired glucose tolerance: results from the Continuous National Health and Nutrition Examination Survey 2009-2010. J Clin Periodontol. 2014 Jul;41(7):643-52. doi: 10.1111/jcpe.12258. Epub 2014 May 25.
Results Reference
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PubMed Identifier
23631575
Citation
Engebretson S, Kocher T. Evidence that periodontal treatment improves diabetes outcomes: a systematic review and meta-analysis. J Periodontol. 2013 Apr;84(4 Suppl):S153-69. doi: 10.1902/jop.2013.1340017.
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PubMed Identifier
23106512
Citation
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Borgnakke WS, Chapple IL, Genco RJ, Armitage G, Bartold PM, D'Aiuto F, Eke PI, Giannobile WV, Kocher T, Kornman KS, Lang NP, Madianos PN, Murakami S, Nishimura F, Offenbacher S, Preshaw PM, Rahman AU, Sanz M, Slots J, Tonetti MS, Van Dyke TE. The multi-center randomized controlled trial (RCT) published by the journal of the American Medical Association (JAMA) on the effect of periodontal therapy on glycated hemoglobin (HbA1c) has fundamental problems. J Evid Based Dent Pract. 2014 Sep;14(3):127-32. doi: 10.1016/j.jebdp.2014.04.017. Epub 2014 May 21.
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Impact of Periodontal Therapy on Patients With Diabetes

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