CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 113 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
Doxycycline 100mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01798225
NCT01798225Phase 4Completed

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

Medical University of South Carolina·interventional·Posted Feb 25, 2013·Updated Oct 4, 2018

In Brief

A Phase 4 clinical trial evaluating Placebo and Doxycycline for Periodontal Disease and Type 2 Diabetes Mellitus. Completed, enrolled 113 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--

Timeline

Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 25, 2013
Enrollment StartDec 1, 2007
Primary CompletionJan 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 13.4 years ago

Interventions

Placebodrug

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

Doxycyclinedrug

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