Post-menopausal Osteoporosis Clinical Trial
Official title:
A Clinical/Real Time Model of Intramembranous Jawbone Healing in Post-menopausal Osteoporotic and Non-osteoporotic Women. A Pilot Study.
Verified date | October 2017 |
Source | University College, London |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Both the pathogenesis and the treatment of osteoporosis may potentially interfere at different levels on the multi-stage complex cascade of events involved in bone healing/regeneration. To our knowledge no human studies have been performed to clarify the potential effect of osteoporosis on post-extraction alveolar healing. The primary outcome of the study is to compare alveolar bone changes in width and height 3 months after tooth extraction in 10 post-menopausal osteoporotic women and 10 post menopausal non osteoporotic women by the use of cone-beam computer tomography (CBCT) images. The secondary outcomes considered are: clinical changes in the external contour of the ridge and periodontal parameters in the neighbouring teeth after a tooth extraction and 3 months later. In addition the accuracy of panoramic morphometric indexes in detecting osteoporosis will be measured.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | November 2015 |
Est. primary completion date | December 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 50 Years and older |
Eligibility |
Inclusion Criteria: - Caucasian women, > 50 years old - women referring to have reached a menopause status, defined as the permanent cessation of the ovulation, since at least 1 year and presenting a diagnosis of osteoporosis based on dual X-rays energy absorptiometry (DXA) measurement of the bone mineral density at the femur neck or lateral spine (t value 2.5 SD or more below the young female adult mean) (TEST GROUP) - women in menopausal status since at least 1 year and with normal bone mineral density, as assessed by DXA scan (CONTROL GROUP) - subjects needing a tooth extraction. The tooth to extract should present at least 30% of its attachment level preserved. Wisdom teeth are excluded from this study - Subjects must have voluntarily signed the informed consent. Exclusion Criteria: - on hormone replacement therapy (HRT) or taking any other drugs (except Vit D and calcium) for the treatment of osteoporosis (e.g. biphosphonates) - on chronic treatment (i.e., two weeks or more) with any medication known to affect oral status (e.g., phenytoin, cyclosporine, and non-steroidal anti-inflammatory drugs) within one month from baseline visit. - affected by systemic diseases recognized to affect bone metabolism (e.g. Cushing's syndrome, Addison's disease, non-controlled diabetes mellitus, leukemia, pernicious anemia, malabsorption syndromes, chronic liver disease, rheumatoid arthritis..) - on therapy with drugs that can affect bone metabolism (e.g. glucocorticoids, anticonvulsants, anticoagulants, benzodiazepines, cytotoxic drugs, immunosuppressants..) - affected by any known diseases, infections or recent surgical procedures within 30 days of study initiation. - knowingly have HIV or Hepatitis - history of local radiation therapy - affected by limited mental capacity or language skills such that study information cannot be understood, informed consent cannot be obtained, or simple instructions cannot be followed. - presented an acute endodontic lesion in the test tooth or in the neighbouring areas to the experimental procedure - smokers - suffering from a known psychological disorder |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Eastman Clinical Investigation Centre | London |
Lead Sponsor | Collaborator |
---|---|
University College, London |
United Kingdom,
Cortet B. Bone repair in osteoporotic bone: postmenopausal and cortisone-induced osteoporosis. Osteoporos Int. 2011 Jun;22(6):2007-10. doi: 10.1007/s00198-011-1612-3. Review. — View Citation
Erdogan O, Shafer DM, Taxel P, Freilich MA. A review of the association between osteoporosis and alveolar ridge augmentation. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2007 Dec;104(6):738.e1-13. Epub 2007 Jul 26. Review. — View Citation
He YX, Zhang G, Pan XH, Liu Z, Zheng LZ, Chan CW, Lee KM, Cao YP, Li G, Wei L, Hung LK, Leung KS, Qin L. Impaired bone healing pattern in mice with ovariectomy-induced osteoporosis: A drill-hole defect model. Bone. 2011 Jun 1;48(6):1388-400. doi: 10.1016/j.bone.2011.03.720. Epub 2011 Mar 21. — View Citation
Shimizu M, Furuya R, Kawawa T, Sasaki T. Bone wound healing after maxillary molar extraction in ovariectomized aged rats: quantitative backscattered electron image analysis. Anat Rec. 2000 May 1;259(1):76-85. — View Citation
Tanaka S, Shimizu M, Debari K, Furuya R, Kawawa T, Sasaki T. Acute effects of ovariectomy on wound healing of alveolar bone after maxillary molar extraction in aged rats. Anat Rec. 2001 Feb 1;262(2):203-12. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | alveolar bone width and height alveolar bone changes in width and height | By the use of CBCT scans, alveolar bone changes in width and height will be recorded just after tooth extraction and 3 months later | within 10 days from tooth extraction and at 3 months (+/- 15 days) | |
Secondary | - Clinical changes of soft and hard tissue and of periodontal parameters in the neighbouring teeth; - Accuracy of panoramic morphometric indexes in detecting osteoporosis | By the use of a probe, periodontal parameters in the neighbouring teeth and relevant clinical changes of the alveolar ridge will be recorded On a panoramic radiograph quantitative and qualitative indexes will be calculated and their accuracy in detecting osteoporosis assessed |
after tooth extraction (once the coagulation has been allowed) and at 3 months (+/- 15 days) |
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