CClinicalTrials.gg
TerminatedNCT02573116EndothSASUpdated Oct 3, 2018

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

An interventional study of scaling and root planing in Cardiovascular Disease in Obstructive Sleep Apnea, sponsored by Hopital Foch. Terminated at 1 site in France. Open to participants aged 30 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-10-03.

Sponsored by Hopital Foch · Not applicable, Interventional, and Treatment

Why this study was terminated
Insufficient recruitment

From the registry’s dates

  • Registered 1 year 6 months after the study started (first participant enrolled Mar 2014, registered Oct 2015).
Phase
Not applicable
Study type
Interventional
Enrollment
49
Allocation
Non-randomized
Ages
30 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cardiovascular Disease in Obstructive Sleep Apnea

Keywords

  • obstructive sleep apnea
  • endothelial dysfunction
  • periodontitis
03

In context

Apnea

1,422 studies on the registry are indexed under Apnea; 159 are open to participants now.

This study's enrollment of 49 is close to the median of 50 across 965 interventional studies indexed under Apnea.

Browse Apnea studies →

Lead sponsor

Hopital Foch is the lead sponsor of 208 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
49 participants (actual)

Study arms

  • 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

  • No intervention
    Obstructive sleep apnea without chronic parodontis

    patients with severe OSA treated by CPAP

Interventions

  • Procedurescaling 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

06

What researchers measure

Primary outcomes

  1. Endothelial function

    measure of Reactive Hyperemia- Peripheral Artery Tone index with Endopat

    Time frame: 20 weeks

Secondary outcomes

  1. Endothelial function

    measure of Reactive Hyperemia- Peripheral Artery Tone index with Endopat

    Time frame: 10 weeks

  2. blood biomarkers

    hsCRP, leptin, adiponectin, E-selectin and orosomucoid

    Time frame: 0, 10 and 20 weeks

  3. Epworth Sleepiness Scale

    Time frame: 0, 10 and 20 weeks

07

Study locations

1 site
  • Hôpital Foch
    Suresnes, 92150, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 3, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02573116
Lead sponsor
Hopital Foch
Responsible party
Sponsor
First posted
Oct 9, 2015
Start date
Mar 24, 2014
Primary completion
Dec 22, 2016
Completion
Jun 6, 2017
Last update
Oct 3, 2018

Study contacts

Priscilla Henno, MD
principal investigator · AP-HP, Hôpital Européen Georges Pompidou

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

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