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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT02184962
Date of registration: 03/07/2014
Prospective Registration: No
Primary sponsor: Universidad Nacional de Córdoba
Public title: Periodontal Disease and Post-menopausal Osteoporosis
Scientific title: "Levels of RANKL and OPG in Gingival Crevicular Fluid of Patients With Post-menopausal Osteoporosis / Osteopenia and Periodontal Disease."
Date of first enrolment: May 2012
Target sample size: 81
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT02184962
Study type:  Observational
Study design:  Observational Model: Case Control, Time Perspective: Cross-Sectional  
Phase:  N/A
Countries of recruitment
Argentina
Contacts
Name:     María E Verde, Odontóloga
Address: 
Telephone:
Email:
Affiliation:  Facultad de Odontología - UNC
Key inclusion & exclusion criteria

Inclusion Criteria:

- Women between 45-70 years with Absorptiometry Dual Energy X-ray (DEXA).

- Control group: post-menopausal women with periodontal disease and normal osseous
condition.

- Study group: post-menopausal womens with periodontal disease and
osteoporosis/osteopenia with and without bisphosphonate treatment (risedronate
or ibandronate 150 mg) for longer than 3 months before the study and another.

Exclusion Criteria:

- Patients with history of aggressive periodontitis and had received any periodontal
treatment when they entered the study

- Patients with any systemic illness (except osteopenia/osteoporosis)

- Patients who received antibiotic or non-steroidal anti-inflammatory therapy in the 6
months prior to the study.



Age minimum: 45 Years
Age maximum: 70 Years
Gender: Female
Health Condition(s) or Problem(s) studied
Osteoporosis
Periodontal Disease
Osteopenia
Intervention(s)
Primary Outcome(s)
levels of RANKL and OPG [Time Frame: one year]
Secondary Outcome(s)
Secondary ID(s)
MEV-2030
UNC-2013
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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