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

Primary Purpose

Cardiovascular Disease in Obstructive Sleep Apnea

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
scaling and root planing
Sponsored by
Hopital Foch
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiovascular Disease in Obstructive Sleep Apnea focused on measuring obstructive sleep apnea, endothelial dysfunction, periodontitis

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital Foch

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Obstructive sleep apnea with chronic parodontis

Obstructive sleep apnea without chronic parodontis

Arm Description

patients with severe obstructive sleep apnea (OSA) and chronic parodontis treated for OSA by continuous positive airway pressure (CPAP) and intensive periodontal treatment

patients with severe OSA treated by CPAP

Outcomes

Primary Outcome Measures

Endothelial function
measure of Reactive Hyperemia- Peripheral Artery Tone index with Endopat

Secondary Outcome Measures

Endothelial function
measure of Reactive Hyperemia- Peripheral Artery Tone index with Endopat
blood biomarkers
hsCRP, leptin, adiponectin, E-selectin and orosomucoid
Epworth Sleepiness Scale

Full Information

First Posted
October 8, 2015
Last Updated
October 1, 2018
Sponsor
Hopital Foch
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1. Study Identification

Unique Protocol Identification Number
NCT02573116
Brief Title
Impact of Treatment of Periodontis on Endothelial Function in Patients With Obstructive Sleep Apnea
Acronym
EndothSAS
Official Title
Impact of Treatment of Periodontis on Endothelial Function in Patients With Obstructive Sleep Apnea
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Terminated
Why Stopped
Insufficient recruitment
Study Start Date
March 24, 2014 (Actual)
Primary Completion Date
December 22, 2016 (Actual)
Study Completion Date
June 6, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hopital Foch

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Disease in Obstructive Sleep Apnea
Keywords
obstructive sleep apnea, endothelial dysfunction, periodontitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Obstructive sleep apnea with chronic parodontis
Arm Type
Experimental
Arm Description
patients with severe obstructive sleep apnea (OSA) and chronic parodontis treated for OSA by continuous positive airway pressure (CPAP) and intensive periodontal treatment
Arm Title
Obstructive sleep apnea without chronic parodontis
Arm Type
No Intervention
Arm Description
patients with severe OSA treated by CPAP
Intervention Type
Procedure
Intervention Name(s)
scaling and root planing
Intervention Description
full-mouth intensive removal of subgingival dental plaque biofilms with the use of scaling and root planing after the administration of local anesthesia
Primary Outcome Measure Information:
Title
Endothelial function
Description
measure of Reactive Hyperemia- Peripheral Artery Tone index with Endopat
Time Frame
20 weeks
Secondary Outcome Measure Information:
Title
Endothelial function
Description
measure of Reactive Hyperemia- Peripheral Artery Tone index with Endopat
Time Frame
10 weeks
Title
blood biomarkers
Description
hsCRP, leptin, adiponectin, E-selectin and orosomucoid
Time Frame
0, 10 and 20 weeks
Title
Epworth Sleepiness Scale
Time Frame
0, 10 and 20 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Priscilla Henno, MD
Organizational Affiliation
AP-HP, Hôpital Européen Georges Pompidou
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Foch
City
Suresnes
ZIP/Postal Code
92150
Country
France

12. IPD Sharing Statement

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

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