Bone Healing in Healthy and Post-menopausal Osteoporotic Women

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2013 by University College, London
Sponsor:
Information provided by (Responsible Party):
University College, London
ClinicalTrials.gov Identifier:
NCT01826656
First received: March 26, 2013
Last updated: September 25, 2013
Last verified: September 2013
  Purpose

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 together with periodontal parameters in the neighbouring teeth.


Condition Intervention
Post-menopausal Osteoporosis
Procedure: tooth extraction
Radiation: CBCT scan
Radiation: DXA scan
Radiation: Panoramic radiograph

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: A Clinical/Real Time Model of Intramembranous Bone Healing in Post-menopausal Osteoporotic and Non-osteoporotic Women. A Pilot Study.

Resource links provided by NLM:


Further study details as provided by University College, London:

Primary Outcome Measures:
  • alveolar bone width and height alveolar bone changes in width and height [ Time Frame: within 2 days from tooth extraction and at 3 months ] [ Designated as safety issue: No ]
    By the use of CBCT scans, alveolar bone changes in width and height will be recorded just after tooth extraction and 3 months later


Secondary Outcome Measures:
  • clinical changes of soft and hard tissue and of periodontal parameters in the neighboring teeth [ Time Frame: after tooth extraction (once the coagulation has been allowed) and at 3 months ] [ Designated as safety issue: No ]
    By the use of a probe, periodontal parameters in the neighbouring teeth and relevant clinical changes of the alveolar ridge will be recorded


Estimated Enrollment: 20
Study Start Date: January 2014
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
post-menopausal osteoporotic women
Subjects of test group will follow a tooth extraction and they will perform a CBCT scan within 2 days from the extraction and after 3 months (+/-2 days)
Procedure: tooth extraction
Patients from both groups will follow the extraction of an hopeless tooth
Radiation: CBCT scan
A CBCT scan will be performed within 2 days from the tooth extraction at after 3 months (+/-2 days)
Radiation: DXA scan
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.
Radiation: Panoramic radiograph
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
Active Comparator: non-osteoporotic post-menopausal women
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
Patients from both groups will follow the extraction of an hopeless tooth
Radiation: CBCT scan
A CBCT scan will be performed within 2 days from the tooth extraction at after 3 months (+/-2 days)
Radiation: DXA scan
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.
Radiation: Panoramic radiograph
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

Detailed Description:

Despite some contradictory results, there is significant pre-clinical evidence, mainly deriving from fracture studies, of a delay in bone formation together with a decrease in bone mineral density and mechanical resistance in osteoporotic-like conditions. Very few human data are available, mainly deriving from retrospective speculations, but they seem to confirm the existence of a delay in consolidation subsequent to bone fractures, a higher rate of orthopedic complications and a reduction in mechanical strength. Some pre-clinical and clinical studies have also supported a negative effect of osteoporosis on bone graft healing and implant success, but controversial opinions exist.

A useful model to study the influence of osteoporosis on bone healing is the post-extraction socket healing, with consideration of the absence of cartilage formation, the short period needed to heal and its clinical relevance.

The animal studies reported controversial results, but a general reduction and a delay in bone formation with an increase in bone turnover was usually observed in ovariectomized rats. No human studies have clarified the effect of osteoporosis on post-extraction alveolar healing. This pilot study will try to shed light on this topic.

As there are no similar studies in the literature, we estimated that 10 post-menopausal osteoporotic women (test) and 10 healthy pre or post-menopausal women (control) would be a convenient sample to collect enough data for our purpose. This will also allow us to collect information about the variance to power a further study (if needed).

In this study, women who need the extraction of a single tooth due to fracture, destroying caries, periodontitis, endodontic or prosthetic reasons will be included. The tooth should present at least 30% of its periodontal attachment preserved. All the patients will be provided a full-mouth diagnosis of soft and hard tissues, detailed hygiene instructions and the careful removal of plaque and tartar in a highly controlled research environment as part of the project and all the treatment will be free of charge. Subjects of the test group will be recruited among newly diagnosed post-menopausal osteoporotic women attending the Rheumatology clinic at the University College of London Hospital, whilst subjects of the control group will be recruited among healthy women attending the Eastman Dental Institute. Written informed consent will be obtained prior to any clinical evaluation. Differences between test and control groups will be assessed at each time interval using either parametric (if data are normally distributed with approximately equal variances) or non-parametric tests.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • subjects 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)
  • subjects in either a menopausal status or with regular menstrual cycles but with no osteoporosis (T score > -1) (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:

  • pregnant or lactating or taking contraceptives (CONTROL GROUP)
  • on hormone replacement therapy (HRT) or taking any other drugs (except Vit D and calcium) for the treatment of osteoporosis (e.g. biphosphonates) (TEST GROUP)
  • on chronic treatment (i.e., two weeks or more) with any medication known to affect oral status (e.g., phenytoin, dihydropyridine calcium antagonists, 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01826656

Contacts
Contact: Nikolaos Donos, Prof +442034561075 n.donos@ucl.ac.uk
Contact: Elena Calciolari, Dr +44 (0) 20 345 62302 elena.calciolari.12@ucl.ac.uk

Locations
United Kingdom
UCL Eastman Dental Institute Not yet recruiting
London, United Kingdom, WC1X 8LD
Sub-Investigator: Elena Calciolari, Dr         
Principal Investigator: Nikolaos Donos, Prof         
Sub-Investigator: Nikos Mardas, Dr         
Sponsors and Collaborators
University College, London
Investigators
Study Chair: Nikolaos Donos, Professor UCL Eastman Dental Institute
  More Information

Publications:
Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT01826656     History of Changes
Other Study ID Numbers: OsteoporosisTrial
Study First Received: March 26, 2013
Last Updated: September 25, 2013
Health Authority: United Kingdom: National Health Service
United Kingdom: Research Ethics Committee

Keywords provided by University College, London:
intramembranous bone healing
post-menopausal osteoporosis
tooth extraction

Additional relevant MeSH terms:
Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on August 19, 2014