Effects of Low-Dose Doxycycline on Oral Bone Loss
The primary purpose of this clinical trial is to determine whether low-dose doxycycline can reduce alveolar bone density loss in postmenopausal osteopenic women with periodontitis and not on hormone replacement therapy (i.e., estrogen deficient).
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Low-Dose Doxycycline Effects on Osteopenic Bone Loss|
- alveolar bone density [ Time Frame: Baseline, one-year and two-year visits ] [ Designated as safety issue: No ]
|Study Start Date:||June 2002|
|Study Completion Date:||October 2005|
|Primary Completion Date:||October 2005 (Final data collection date for primary outcome measure)|
Experimental: A vs. B
The experimental group received low-dose doxycycline; the placebo group received a placebo control.
Drug: 20 mg doxycycline hyclate
Subjects in the LDD group took 20 mg doxycycline hyclate tablets twice daily for two years; subjects in the placebo group took a placebo look-alike twice daily for two years.
The primary purpose of this clinical trial is to determine whether low-dose doxycycline (LDD) can reduce alveolar bone density loss in postmenopausal osteopenic women with periodontitis and not on hormone replacement therapy (i.e., estrogen deficient). The effects of LDD on alveolar bone height loss, progressive periodontal attachment loss, systemic bone mineral density, gingival crevicular fluid biochemical markers of collagen degradation and bone resorption and serum biomarkers of bone formation, bone resorption and inflammation also will be assessed. In addition, another objective is to determine if the microbial effects obtained with LDD over two years are equivalent to a placebo control. This clinical trial involves two clinical sites: the University of Nebraska Medical Center College of Dentistry and Stony Brook University School of Dental Medicine. A total of 128 postmenopausal osteopenic women with periodontitis between the ages of 45 and 70 at the time of telephone screening will be randomized to LDD or placebo groups and subjects will be followed for two years.
|United States, Nebraska|
|UNMC College of Dentistry|
|Lincoln, Nebraska, United States, 68583-0740|
|United States, New York|
|Department of Oral Biology and Pathology|
|Stony Brook, New York, United States, 11794-8702|
|Principal Investigator:||Jeffrey B Payne, Dr||UNMC College of Dentistry|