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.
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.
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.
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