A Clinical/Real Time Model of Intramembranous Jawbone Healing in Post-menopausal Osteoporotic and Non-osteoporotic Women. A Pilot Study.

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.