Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
128 participants
INTERVENTIONAL
2002-06-01
2005-10-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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low-dose doxycycline
low-dose doxycycline (20 mg doxycycline hyclate)
20 mg doxycycline hyclate
Subjects in the LDD group took 20 mg doxycycline hyclate tablets twice daily for two years
Placebo
Placebo
Placebo
Subjects in the placebo group took a placebo look-alike twice daily for two years.
Interventions
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20 mg doxycycline hyclate
Subjects in the LDD group took 20 mg doxycycline hyclate tablets twice daily for two years
Placebo
Subjects in the placebo group took a placebo look-alike twice daily for two years.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
45 Years
70 Years
FEMALE
No
Sponsors
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National Institute of Dental and Craniofacial Research (NIDCR)
NIH
University of Nebraska
OTHER
Responsible Party
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Principal Investigators
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Jeffrey B Payne, DDS
Role: PRINCIPAL_INVESTIGATOR
UNMC College of Dentistry
Locations
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University of Nebraska Medical Center, College of Dentistry
Lincoln, Nebraska, United States
Department of Oral Biology and Pathology
Stony Brook, New York, United States
Countries
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References
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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.
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/s00011-013-0626-z. Epub 2013 May 7.
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.
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.
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 Am Dent Assoc. 2011 Mar;142(3):262-73. doi: 10.14219/jada.archive.2011.0165.
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.
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.
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/jop.2009.090374.
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;79(8):1409-18. doi: 10.1902/jop.2008.070623.
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.
Payne JB, Stoner JA, Lee HM, Nummikoski PV, Reinhardt RA, Golub LM. Serum bone biomarkers and oral/systemic bone loss in humans. J Dent Res. 2011 Jun;90(6):747-51. doi: 10.1177/0022034511402993. Epub 2011 Mar 21.
Payne JB, Stoner JA, Nummikoski PV, Reinhardt RA, Goren AD, Wolff MS, Lee HM, Lynch JC, Valente R, Golub LM. Subantimicrobial dose doxycycline effects on alveolar bone loss in post-menopausal women. J Clin Periodontol. 2007 Sep;34(9):776-87. doi: 10.1111/j.1600-051X.2007.01115.x.
Reinhardt RA, Stoner JA, Golub LM, Wolff MS, Lee HM, Meinberg TA, Lynch JC, Ryan ME, Sorsa T, Payne JB. Efficacy of sub-antimicrobial dose doxycycline in post-menopausal women: clinical outcomes. J Clin Periodontol. 2007 Sep;34(9):768-75. doi: 10.1111/j.1600-051X.2007.01114.x.
Other Identifiers
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0511-00-FB
Identifier Type: -
Identifier Source: org_study_id
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