Periodontal Disease and Post-menopausal Osteoporosis

Osteoporosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02184962
• Other study ID #: MEV-2030
• Secondary ID: UNC-2013
• Status: Completed
• Phase: N/A
• First received: July 3, 2014
• Last updated: July 8, 2014
• Start date: May 2012
• Est. completion date: September 2013

Study information

• Verified date: July 2014
• Source: Universidad Nacional de Córdoba
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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 "

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 70 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Gingival Diseases
• Osteopenia
• Osteoporosis
• Osteoporosis, Postmenopausal
• Periodontal Disease
• Periodontal Diseases

Locations

Country	Name	City	State
Argentina	Facultad de Odontología - Universidad Nacional de Córdoba	Córdoba

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Nacional de Córdoba

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	levels of RANKL and OPG		one year	No