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Completed

NCT Number: NCT02184962

Periodontal Disease and Post-menopausal Osteoporosis

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 "

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Key information

Age range

45 year–70 year

Sex eligibility

Female

Study type

Observational

Primary location

Facultad de Odontología - Universidad Nacional de Córdoba

Córdoba, Córdoba Province, 5000, Argentina

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. levels of RANKL and OPG

    Time frame: one year

Sponsors and collaborators

Lead sponsor

Universidad Nacional de Córdoba

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jul 9, 2014
Registry last updated
Jul 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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