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Clinical Trials/NCT02573116
NCT02573116
Terminated
Not Applicable

Impact of Treatment of Periodontis on Endothelial Function in Patients With Obstructive Sleep Apnea

Hopital Foch1 site in 1 country49 target enrollmentMarch 24, 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiovascular Disease in Obstructive Sleep Apnea
Sponsor
Hopital Foch
Enrollment
49
Locations
1
Primary Endpoint
Endothelial function
Status
Terminated
Last Updated
7 years ago

Overview

Brief Summary

Evaluation of the add-on effect on endothelial dysfunction of treatment of periodontitis in patients with chronic periodontitis and severe obstructive sleep apnea treated by CPAP. Patients with and without chronic periodontitis will be treated by CPAP for 20 weeks. At V2 (10 weeks), endothelial dysfunction will be assessed by the Reactive Hyperemia- Peripheral Artery Tone index. The endothelial dysfunction of the patients will be also assessed at V3 (20 weeks) after periodontitis treatment for the group of patients with chronic periodontitis.

Detailed Description

At V2, patients with periodontitis will have full-mouth intensive removal of denatl plaque biofilms with the use of scaling and root planing. The add-on effect of the periodontitis treatment on endothelial dysfunction will be assessed ten weeks later (V3) in comparison with V2 by taking into account with the effect of 10 weeks of CPAP in the control group with severe OSA but not periodontitis.

Registry
clinicaltrials.gov
Start Date
March 24, 2014
End Date
June 6, 2017
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • severe OSA defined by an apnea hypopnea index \> or = 30 per hour
  • with or without chronic parodontitis

Exclusion Criteria

  • non equilibrated diabetes
  • obesity (BMI \> or = 40)
  • active smoker (\> 1 pack per day (20 cigarettes))
  • pregnancy
  • antibiotics within the preceding three months
  • prophylactic antibiotherapy required for the parodontitis treatment
  • acute parodontitis or all parontal pathology requiring immediate therapy
  • less than 10 teeth

Outcomes

Primary Outcomes

Endothelial function

Time Frame: 20 weeks

measure of Reactive Hyperemia- Peripheral Artery Tone index with Endopat

Secondary Outcomes

  • Endothelial function(10 weeks)
  • blood biomarkers(0, 10 and 20 weeks)
  • Epworth Sleepiness Scale(0, 10 and 20 weeks)

Study Sites (1)

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