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Register:	ClinicalTrials.gov
Last refreshed on:	6 October 2015
Main ID:	NCT02115490
Date of registration:	11/04/2014
Prospective Registration:	No
Primary sponsor:	Damascus University
Public title:	Bisphosphonates Effects On Alveolar Bone Among Osteoporotic Women
Scientific title:	The Effect of Orally Administered Bisphosphonates in the Treatment of Osteoporosis on the Alveolar Bone Using Panoramic and Cone-Beam CT Imaging: A Case-control Study
Date of first enrolment:	April 2014
Target sample size:	60
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02115490
Study type:	Observational
Study design:	Observational Model: Case Control, Time Perspective: Prospective
Phase:	N/A

Countries of recruitment
Syrian Arab Republic

Contacts

Name:	Iyad Al-Haffar, DDS MSc PhD
Address:
Telephone:
Email:
Affiliation:	Associate Professor of Oral Medicine, Department of Oral Medicine, University of Damascus Dental School, Damascus

Name:	Imad Barngkgei, DDS MSc
Address:
Telephone:
Email:
Affiliation:	PhD student, Department of Oral Medicine, University of Damascus Dental School, Damascus

Name:	Razan Khattab, DDS MSc PhD
Address:
Telephone:
Email:
Affiliation:	Professor of Periodontology, Department of Periodontology, University of Damascus Dental School, Damascus, SYRIA

Key inclusion & exclusion criteria

Inclusion Criteria:

- Women with osteoporosis who already use bisphosphonates.

- Women with osteoporosis who are not under bisphosphonates yet, or are not indicated
for such therapy.

- Women with osteopenia either using or not bisphosphonates.

Exclusion Criteria:

- Women with bone diseases other than osteoporosis or osteopenia

Age minimum: 45 Years
Age maximum: 75 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Osteoporosis

Intervention(s)

Drug: Bisphosphonates

Primary Outcome(s)

3D-based Alveolar bone radiographic density [Time Frame: One-time assessment; once the woman is scanned by CBCT]

Secondary Outcome(s)

2D-based Alveolar bone radiographic density [Time Frame: One-time assessment; once the patient is radiographed]

Periodontal Disease Index (PDI) [Time Frame: One-time assessment in the day of performing the X-ray imaging]

Alveolar bone histomorphometry [Time Frame: One-time assessment; once the patient is scanned by CBCT]

Secondary ID(s)

UDDS-OraMed-01-2014

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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