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Trial record 3 of 48 for:    gum disease | NIH

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

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ClinicalTrials.gov Identifier: NCT01798225
Recruitment Status : Completed
First Posted : February 25, 2013
Results First Posted : October 4, 2018
Last Update Posted : October 4, 2018
Sponsor:
Collaborator:
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
Medical University of South Carolina

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Periodontal Disease
Type 2 Diabetes Mellitus
Interventions Drug: Placebo
Drug: Doxycycline
Enrollment 113
Recruitment Details Recruitment period from 12/18/2007 to 01/12/2010. Recruitment happened from previous studies and community events.
Pre-assignment Details  
Arm/Group Title Control Doxycycline
Hide Arm/Group Description

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

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

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)

Period Title: Overall Study
Started 57 56
Completed 57 53
Not Completed 0 3
Arm/Group Title Control Doxycycline Total
Hide Arm/Group Description

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

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

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)

Total of all reporting groups
Overall Number of Baseline Participants 57 56 113
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 57 participants 56 participants 113 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
45
  78.9%
43
  76.8%
88
  77.9%
>=65 years
12
  21.1%
13
  23.2%
25
  22.1%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 57 participants 56 participants 113 participants
Female
47
  82.5%
38
  67.9%
85
  75.2%
Male
10
  17.5%
18
  32.1%
28
  24.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 57 participants 56 participants 113 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
57
 100.0%
56
 100.0%
113
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 57 participants 56 participants 113 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
57
 100.0%
56
 100.0%
113
 100.0%
White
0
   0.0%
0
   0.0%
0
   0.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 57 participants 56 participants 113 participants
57 56 113
1.Primary Outcome
Title Glycated Hemoglobin A1c
Hide Description Glycated Hemoglobin A1c
Time Frame Change between baseline to 6-month post-treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Doxycycline
Hide Arm/Group Description:

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

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

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)

Overall Number of Participants Analyzed 57 56
Mean (Full Range)
Unit of Measure: percentage of Glycated Hemoglobin A1c
8
(5.3 to 12.8)
8.2
(4.7 to 14.1)
2.Primary Outcome
Title Periodontal Pocket Probing Depth (PD)
Hide Description [Not Specified]
Time Frame Change between baseline to 6-month post-treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Doxycycline
Hide Arm/Group Description:

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

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

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)

Overall Number of Participants Analyzed 57 56
Mean (Standard Error)
Unit of Measure: mm
-1.98  (0.0001) -1.37  (0.0001)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Control Doxycycline
Hide Arm/Group Description

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

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

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)

All-Cause Mortality
Control Doxycycline
Affected / at Risk (%) Affected / at Risk (%)
Total   0/57 (0.00%)   0/56 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Control Doxycycline
Affected / at Risk (%) Affected / at Risk (%)
Total   0/57 (0.00%)   0/56 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Control Doxycycline
Affected / at Risk (%) Affected / at Risk (%)
Total   0/57 (0.00%)   0/56 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Renata Leite
Organization: Medical University of South Carolina
Phone: 843-792-3908
Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01798225     History of Changes
Other Study ID Numbers: P20RR017696-06 ( U.S. NIH Grant/Contract )
P20RR017696 ( U.S. NIH Grant/Contract )
First Submitted: April 18, 2012
First Posted: February 25, 2013
Results First Submitted: May 4, 2017
Results First Posted: October 4, 2018
Last Update Posted: October 4, 2018