Skip to content

Relationship of Periodontal Disease Treatment and Type 2 Diabetes Mellitus in the Gullah Population

The Relationships Between Periodontal Disease and Type 2 Diabetes Mellitus in the Gullah Population and the Effects of Mechanical Periodontal Therapy and Systemic Antibiotics on the Glycemic Control

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01798225
Enrollment
113
Registered
2013-02-25
Start date
2007-12-31
Completion date
2010-01-31
Last updated
2018-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periodontal Disease, Type 2 Diabetes Mellitus

Keywords

Periodontal Disease, Type 2 Diabetes Mellitus, Gullah African Americans

Brief summary

Our overall hypothesis is that treatment of periodontal disease will produce better diabetes glycemic control (glycated hemoglobin A1c, or HbA1c) and reduced levels of the catalytically active form of matrix metalloproteinase (aMMP-8) in the Gullah African American type 2 diabetes patients living on the Sea Islands of the South Carolina coast. The gingival crevicular fluid (GCF) aMMP-8 levels will be measured through a site-specific, novel noninvasive technique allowing the pathophysiological status of the periodontium tissue to be monitored. The investigators will conduct an interventional study on this population with minimal genetic admixture.

Detailed description

Specific Aim 1: To ascertain the rate of periodontal disease progression on poorly controlled Type 2 diabetic Gullah African American patients as compared to well-controlled Gullah African American patients. The host inflammatory response appears to be the critical determinant for susceptibility and severity of marginal periodontitis especially in systemically compromised individuals13, with diabetic status perhaps increasing host susceptibility to periodontal infection due to impaired immune response14. Patients have been evaluated 6 months to one year prior to periodontal therapy (this evaluation is connected to a previous COBRE project entitled Epidemiological Study of Periodontal Disease and Diabetes by Dr. J. Fernandes). A reevaluation will be made at the time of periodontal therapy. Clinical periodontal parameters and HbA1c levels will be compared. Specific Aim 2: To assess the effects of successful periodontal therapy on the level of glycemic control in this Gullah African American population. Authors addressing whether the treatment of periodontitis or other infections of the oral cavity can improve glycemic control in diabetic patients report contradictory results. We will treat periodontal patients with mechanical therapy (scaling and root planning) and oral hygiene instruction, with or without systemic antibiotic administration (Table 1). The HbA1c, fasting glucose and clinical periodontal parameters will be evaluated prior to the periodontal intervention, and at 3 and 6 months after therapy. We plan to continue to recruit, enroll and assess new patients from the Gullah African American community living on the Sea Islands of the South Carolina coast for future research projects Specific Aim 3: To assess the concentration of the catalytically active form of MMP-8 at baseline (prior to periodontal intervention) and at 3 and 6 months later. Polymorphonuclear (PMN) leukocyte-derived MMP-8 is predominantly present in periodontitis-affected GCF9,15-16. Analysis of GCF for aMMP-8 could provide a novel useful noninvasive technique to assess and monitor the pathophysiological status of the periodontium tissue in a site-specific manner9-10.

Interventions

DRUGPlacebo

Participants received mechanical periodontal therapy, oral hygiene instructions and placebo pills.

DRUGDoxycycline

Participants received mechanical periodontal therapy, oral hygiene instructions and Doxycycline 100mg x 14 pills (to be taken one a day for 14 days)

Sponsors

National Center for Research Resources (NCRR)
CollaboratorNIH
Medical University of South Carolina
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
13 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Gullah African Americans; * With type 2 diabetes mellitus defined according to the American Diabetes Association criteria; Other inclusion criteria are presented under each Specific Aim: * AIM 1: Participants who have received oral, dental, periodontal, diabetes and genotype assessment through enrollment in Dr. J. Fernandes' COBRE project. * AIM 2 and 3: Participants with severe chronic periodontitis, as defined by at least one tooth surface with probing depth (PD)≥5mm.

Exclusion criteria

* Severe concurrent illnesses / conditions that would limit their daily life or require extensive systemic treatment, such as malignancy, severe cardiovascular disease, organ transplant, or inadequate understanding due to mental disorders; * Finger stick blood glucose measurement of more than 350mg/dl or less than 70mg/dl after second measurement; * Systolic blood pressure of more than 180mm Hg or diastolic pressure of more than 100mm Hg; * Fasting serum C-peptide \< 1ng/ml (documentation or test); * Serum creatinine ≥ 1.6mg/dl; * Abnormal hepatic function; * Hemoglobinopathy (sickle cell trait/hemolytic anemia) interfering with HbA1c monitoring; * Other underlying illness/conditions which, in the doctor's judgment, may prevent patient from adherence to the study protocol; * Unwillingness to sign the informed consent form or enter the study; * Pregnant women; * Patients in need of antibiotic prophylaxis prior to dental procedures or patients that have been treated with any kind of antibiotics in the past 3 months.

Design outcomes

Primary

MeasureTime frameDescription
Glycated Hemoglobin A1cChange between baseline to 6-month post-treatmentGlycated Hemoglobin A1c
Periodontal Pocket Probing Depth (PD)Change between baseline to 6-month post-treatment

Participant flow

Recruitment details

Recruitment period from 12/18/2007 to 01/12/2010. Recruitment happened from previous studies and community events.

Participants by arm

ArmCount
Control
Participants received mechanical periodontal therapy, oral hygiene instructions and placebo (antibiotic) pills. Placebo: Participants received mechanical periodontal therapy, oral hygiene instructions and placebo pills.
57
Doxycycline
Participants received mechanical periodontal therapy, oral hygiene instructions and antibiotic (Doxycycline 100mg x 14 pills) Doxycycline: Participants received mechanical periodontal therapy, oral hygiene instructions and Doxycycline 100mg x 14 pills (to be taken one a day for 14 days)
56
Total113

Baseline characteristics

CharacteristicControlDoxycyclineTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
12 Participants13 Participants25 Participants
Age, Categorical
Between 18 and 65 years
45 Participants43 Participants88 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
57 Participants56 Participants113 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
57 Participants56 Participants113 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
0 Participants0 Participants0 Participants
Region of Enrollment
United States
57 participants56 participants113 participants
Sex: Female, Male
Female
47 Participants38 Participants85 Participants
Sex: Female, Male
Male
10 Participants18 Participants28 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 570 / 56
other
Total, other adverse events
0 / 570 / 56
serious
Total, serious adverse events
0 / 570 / 56

Outcome results

Primary

Glycated Hemoglobin A1c

Glycated Hemoglobin A1c

Time frame: Change between baseline to 6-month post-treatment

ArmMeasureValue (MEAN)
ControlGlycated Hemoglobin A1c8 percentage of Glycated Hemoglobin A1c
DoxycyclineGlycated Hemoglobin A1c8.2 percentage of Glycated Hemoglobin A1c
Primary

Periodontal Pocket Probing Depth (PD)

Time frame: Change between baseline to 6-month post-treatment

ArmMeasureValue (MEAN)Dispersion
ControlPeriodontal Pocket Probing Depth (PD)-1.98 mmStandard Error 0.0001
DoxycyclinePeriodontal Pocket Probing Depth (PD)-1.37 mmStandard Error 0.0001

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026