Periodontal Disease and Post-menopausal Osteoporosis

NCT ID: NCT02184962

Last Updated: 2014-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

81 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-05-31

Study Completion Date

2013-09-30

Brief Summary

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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 "

Detailed Description

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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.

Conditions

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Osteoporosis Osteopenia Periodontal Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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.
Minimum Eligible Age

45 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Universidad Nacional de Córdoba

OTHER

Sponsor Role lead

Responsible Party

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María Eugenia Verde

María Eugenia Verde - Cátedra de Periodoncia A - UNC

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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María E Verde, Odontóloga

Role: PRINCIPAL_INVESTIGATOR

Facultad de Odontología - UNC

Locations

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Facultad de Odontología - Universidad Nacional de Córdoba

Córdoba, Córdoba Province, Argentina

Site Status

Countries

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Argentina

Other Identifiers

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UNC-2013

Identifier Type: REGISTRY

Identifier Source: secondary_id

MEV-2030

Identifier Type: -

Identifier Source: org_study_id

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