Periodontal Disease and Post-menopausal Osteoporosis

July 8, 2014 updated by: María Eugenia Verde, Universidad Nacional de Córdoba

"Levels of RANKL and OPG in Gingival Crevicular Fluid of Patients With Post-menopausal Osteoporosis / Osteopenia and Periodontal Disease."

The aim of this study was to investigate the levels of RANKL and Osteoprotegerin, and their relationship in gingival crevicular fluid of post-menopausal women with osteoporosis/osteopenia and chronic periodontitis simultaneously and evaluate the effect that the use of bisphosphonates in periodontal disease.

Study hypothesis:

"The osteoporosis / osteopenia in postmenopausal women patients with periodontal disease affect the ratio RANKL / OPG in gingival crevicular fluid samples favoring osteoclastogenesis processes "

Study Overview

Status

Completed

Conditions

Detailed Description

81 active periodontal sites from 31 postmenopausal women aged 45-70 years with chronic periodontitis were studied. Samples of gingival crevicular fluid were collected by paper strips and ELISA test was conducted to determine the total concentration of RANKL, OPG, and then obtain the values of the RANKL / OPG ratio. We analyzed 66 samples of gingival crevicular fluid obtained from active periodontal sites of 17 patients with osteopenia / osteoporosis and 15 samples gingival crevicular fluid obtained from active periodontal sites obtained of 14 controls patients with normal osseous condition.

Statistical analyzes were computed and analyzed using Graphpad Software. To determine if the data correspond to a normal distribution the D'Agostino-Pearson test was used. The values of cytokines (RANKL and OPG) and its ratio (RANKL / OPG) were compared using Mann-Whitney Test t U. Analysis Spearman correlation and linear regression for statistic was also performed to determine whether there was any relationship between the variables analyzed. It was considered as statistically significant p value ≤ 0.05.

Study Type

Observational

Enrollment (Actual)

81

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Córdoba, Argentina, 5000
        • Facultad de Odontología - Universidad Nacional de Córdoba

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Patients with osteopenia / osteoporosis and controls with normal osseous condition. Both groups with chronic periodontitis

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
levels of RANKL and OPG
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Nacional de Córdoba

Investigators

  • Principal Investigator: María E Verde, Odontóloga, Facultad de Odontología - UNC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

July 3, 2014

First Submitted That Met QC Criteria

July 8, 2014

First Posted (Estimate)

July 9, 2014

Study Record Updates

Last Update Posted (Estimate)

July 9, 2014

Last Update Submitted That Met QC Criteria

July 8, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEV-2030
  • UNC-2013 (Registry Identifier: UCordoba)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Osteoporosis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Serbia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe