Periodontitis Clinical Trial
Official title:
Low-Dose Doxycycline Effects on Osteopenic Bone Loss
Verified date | September 2023 |
Source | University of Nebraska |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 128 |
Est. completion date | October 1, 2005 |
Est. primary completion date | October 1, 2005 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 45 Years to 70 Years |
Eligibility | Inclusion Criteria: - Subjects will be female, postmenopausal and not receiving estrogen replacement therapy. - Subjects will be 45-70 years old at the time of telephone screening. - Subjects will have osteopenia (T-score of -1.0 to -2.5) of the lumbar spine or femoral neck as determined by dual-energy absorptiometry (DEXA) scans. - Subjects will have a history of generalized moderate-advanced periodontitis and will be undergoing periodontal maintenance. - Subjects will be in good general health and willing to sign the IRB-approved consent form. Exclusion Criteria: - Subjects will not have an allergy or hypersensitivity to tetracyclines. - Subjects will not have diseases or take medications that affect the inflammatory or immune responses (e.g., chronic use of non-steroidal anti-inflammatory drugs) or bone remodeling (e.g., drugs such as prescription estrogens, bisphosphonates, calcitonin or steroids). - Subjects will not have any medical condition requiring antibiotic premedication (e.g., prosthetic heart valves, prosthetic joints, and mitral valve prolapse with regurgitation) for routine dental therapy. - Subjects cannot have diabetes mellitus. - Subjects cannot have had active periodontal therapy (quadrant scaling and root planing or periodontal surgery) within the past year. - Subjects cannot have osteoporosis (T-score greater than -2.5) of the lumbar spine or femoral neck. |
Country | Name | City | State |
---|---|---|---|
United States | University of Nebraska Medical Center, College of Dentistry | Lincoln | Nebraska |
United States | Department of Oral Biology and Pathology | Stony Brook | New York |
Lead Sponsor | Collaborator |
---|---|
University of Nebraska | National Institute of Dental and Craniofacial Research (NIDCR) |
United States,
Golub LM, Lee HM, Stoner JA, Reinhardt RA, Sorsa T, Goren AD, Payne JB. Doxycycline effects on serum bone biomarkers in post-menopausal women. J Dent Res. 2010 Jun;89(6):644-9. doi: 10.1177/0022034510363367. Epub 2010 Mar 26. — View Citation
Golub LM, Lee HM, Stoner JA, Sorsa T, Reinhardt RA, Wolff MS, Ryan ME, Nummikoski PV, Payne JB. Subantimicrobial-dose doxycycline modulates gingival crevicular fluid biomarkers of periodontitis in postmenopausal osteopenic women. J Periodontol. 2008 Aug;7 — View Citation
Gu Y, Walker C, Ryan ME, Payne JB, Golub LM. Non-antibacterial tetracycline formulations: clinical applications in dentistry and medicine. J Oral Microbiol. 2012;4. doi: 10.3402/jom.v4i0.19227. Epub 2012 Oct 12. — View Citation
Payne JB, Golub LM, Stoner JA, Lee HM, Reinhardt RA, Sorsa T, Slepian MJ. The effect of subantimicrobial-dose-doxycycline periodontal therapy on serum biomarkers of systemic inflammation: a randomized, double-masked, placebo-controlled clinical trial. J A — View Citation
Payne JB, Golub LM. Using tetracyclines to treat osteoporotic/osteopenic bone loss: from the basic science laboratory to the clinic. Pharmacol Res. 2011 Feb;63(2):121-9. doi: 10.1016/j.phrs.2010.10.006. Epub 2010 Oct 16. — View Citation
Payne JB, Nummikoski PV, Thompson DM, Golub LM, Stoner JA. The association between clinical and radiographic periodontitis measurements during periodontal maintenance. J Periodontol. 2013 Oct;84(10):1382-90. doi: 10.1902/jop.2012.120484. Epub 2012 Dec 3. — View Citation
Reinhardt RA, Stoner JA, Golub LM, Lee HM, Nummikoski PV, Sorsa T, Payne JB. Association of gingival crevicular fluid biomarkers during periodontal maintenance with subsequent progressive periodontitis. J Periodontol. 2010 Feb;81(2):251-9. doi: 10.1902/jo — View Citation
Salminen A, Pussinen PJ, Payne JB, Stoner JA, Jauhiainen M, Golub LM, Lee HM, Thompson DM, Sorsa T. Subantimicrobial-dose doxycycline treatment increases serum cholesterol efflux capacity from macrophages. Inflamm Res. 2013 Jul;62(7):711-20. doi: 10.1007/ — View Citation
Stoner JA, Payne JB. Interpretation of treatment effects in periodontal research: a note on the number needed to treat. J Can Dent Assoc. 2008 Jun;74(5):435-7. No abstract available. — View Citation
Walker C, Puumala S, Golub LM, Stoner JA, Reinhardt RA, Lee HM, Payne JB. Subantimicrobial dose doxycycline effects on osteopenic bone loss: microbiologic results. J Periodontol. 2007 Aug;78(8):1590-601. doi: 10.1902/jop.2007.070015. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Alveolar Bone Density | Alveolar bone density changes assessed by radiographic absorptiometry and computer-assisted densitometric image analysis. | Baseline, one-year and two-year visits |
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