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| ID | Type | Description | Link |
|---|---|---|---|
| R01DE012872 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Dental and Craniofacial Research (NIDCR) | NIH |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| low-dose doxycycline | Experimental | low-dose doxycycline (20 mg doxycycline hyclate) |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 20 mg doxycycline hyclate | Drug | Subjects in the LDD group took 20 mg doxycycline hyclate tablets twice daily for two years |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey B Payne, DDS | UNMC College of Dentistry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Nebraska Medical Center, College of Dentistry | Lincoln | Nebraska | 68583-0740 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18538066 | Background | 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. | |
| 23649042 | Result | 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. |
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| ID | Term |
|---|---|
| D010518 | Periodontitis |
| D001851 | Bone Diseases, Metabolic |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D001847 | Bone Diseases |
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| ID | Term |
|---|---|
| D004318 | Doxycycline |
| D000900 | Anti-Bacterial Agents |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| Placebo | Drug | Subjects in the placebo group took a placebo look-alike twice daily for two years. |
|
|
| Department of Oral Biology and Pathology |
| Stony Brook |
| New York |
| 11794-8702 |
| United States |
| 23205917 | Result | 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. |
| 23071896 | Result | 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. |
| 21357860 | Result | 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. |
| 20937388 | Result | 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. |
| 20348487 | Result | 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. |
| 20151804 | Result | 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. |
| 18672990 | Result | 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. |
| 17668979 | Result | 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. |
| 21422479 | Derived | 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. |
| 17716313 | Derived | 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. |
| 17716312 | Derived | 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. |
| D009140 |
| Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000890 | Anti-Infective Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D002241 | Carbohydrates |