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Bone Healing in Healthy and Post-menopausal Osteoporotic Women

NCT01826656 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2017-10-27

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • University College, London

    lead OTHER

Principal Investigators

  • Nikolaos Donos, Professor · UCL Eastman Dental Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2014-12-31
Completion
2015-11-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01826656 on ClinicalTrials.gov