Bone Healing in Healthy and Post-menopausal Osteoporotic Women

NCT01826656 | Withdrawn

• 1 other identifier: OsteoporosisTrial
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Post-menopausal Osteoporosis

Keywords

intramembranous bone healing; post-menopausal osteoporosis; tooth extraction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• - Clinical changes of soft and hard tissue and of periodontal parameters in the neighbouring teeth; - Accuracy of panoramic morphometric indexes in detecting osteoporosis

  after tooth extraction (once the coagulation has been allowed) and at 3 months (+/- 15 days)

Study Arms (2)

post-menopausal osteoporotic women

OTHER

Subjects of test group will follow a tooth extraction and they will perform a CBCT scan within 10 days from the extraction and after 3 months (+/-15 days)

Procedure: tooth extraction; Radiation: CBCT scan; Radiation: DXA scan; Radiation: Panoramic radiograph

non-osteoporotic post-menopausal women

ACTIVE COMPARATOR

Subjects of the control group will follow a tooth extraction and will perform a CBCT scan within 2 days from the extraction and after 3 months (+/- 2 days)

Procedure: tooth extraction; Radiation: CBCT scan; Radiation: DXA scan; Radiation: Panoramic radiograph

Interventions

tooth extraction PROCEDURE

Patients from both groups will follow the extraction of an hopeless tooth

non-osteoporotic post-menopausal women; post-menopausal osteoporotic women

CBCT scan RADIATION

A CBCT scan will be performed within 2 days from the tooth extraction at after 3 months (+/-2 days)

non-osteoporotic post-menopausal women; post-menopausal osteoporotic women

DXA scan RADIATION

DXA scan will be performed at the hip and lumbar spine in all self-reported non-osteoporotic subjects who hasn't done one within 1 year, to confirm their normal bone mineral density. Osteoporotic subjects already have a DXA scanner.

non-osteoporotic post-menopausal women; post-menopausal osteoporotic women

Panoramic radiograph RADIATION

As basic standard of care, a panoramic radiograph will be performed to both test and control subjects who haven't done one within the previous year, in order to give them a full-mouth dental diagnosis

non-osteoporotic post-menopausal women; post-menopausal osteoporotic women

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University College, London: lead

Study Sites (1)

Eastman Clinical Investigation Centre

London, WC1X 8LD, United Kingdom

Location

Related Publications (5)

• 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.

  PMID: 21523399 BACKGROUND

• 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. doi: 10.1002/(SICI)1097-0185(20000501)259:13.0.CO;2-0.

  PMID: 10760746 BACKGROUND

• 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. doi: 10.1002/1097-0185(20010201)262:23.0.CO;2-#.

  PMID: 11169915 BACKGROUND

• 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.

  PMID: 21421090 BACKGROUND

• 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. doi: 10.1016/j.tripleo.2007.04.008. Epub 2007 Jul 26.

  PMID: 17656117 BACKGROUND

MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Interventions

Tooth Extraction; Absorptiometry, Photon; Radiography, Panoramic

Condition Hierarchy (Ancestors)

Osteoporosis; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Oral Surgical Procedures; Surgical Procedures, Operative; Dentistry; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Densitometry; Photometry; Chemistry Techniques, Analytical; Investigative Techniques; Radiography, Dental; Diagnosis, Oral

Study Officials

• Nikolaos Donos, Professor

  UCL Eastman Dental Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2013
• First Posted: April 8, 2013
• Study Start: May 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: November 1, 2015
• Last Updated: October 27, 2017

Record last verified: 2017-10

Locations

GB (1)