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

October 1, 2018 updated by: Hopital Foch
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Not Applicable

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

  • France
      • Suresnes, France, 92150
        • Hopital Foch

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

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Obstructive sleep apnea with chronic parodontis
patients with severe obstructive sleep apnea (OSA) and chronic parodontis treated for OSA by continuous positive airway pressure (CPAP) and intensive periodontal treatment
Procedure: scaling and root planing
full-mouth intensive removal of subgingival dental plaque biofilms with the use of scaling and root planing after the administration of local anesthesia
No Intervention: Obstructive sleep apnea without chronic parodontis
patients with severe OSA treated by CPAP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endothelial function
Time Frame: 20 weeks
measure of Reactive Hyperemia- Peripheral Artery Tone index with Endopat
20 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endothelial function
Time Frame: 10 weeks
measure of Reactive Hyperemia- Peripheral Artery Tone index with Endopat
10 weeks
blood biomarkers
Time Frame: 0, 10 and 20 weeks
hsCRP, leptin, adiponectin, E-selectin and orosomucoid
0, 10 and 20 weeks
Epworth Sleepiness Scale
Time Frame: 0, 10 and 20 weeks
0, 10 and 20 weeks

Collaborators and Investigators

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

Sponsor

Hopital Foch

Investigators

  • Principal Investigator: Priscilla Henno, MD, AP-HP, Hôpital Européen Georges Pompidou

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 (Actual)

March 24, 2014

Primary Completion (Actual)

December 22, 2016

Study Completion (Actual)

June 6, 2017

Study Registration Dates

First Submitted

October 8, 2015

First Submitted That Met QC Criteria

October 8, 2015

First Posted (Estimate)

October 9, 2015

Study Record Updates

Last Update Posted (Actual)

October 3, 2018

Last Update Submitted That Met QC Criteria

October 1, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013/44

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.

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