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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02573116
Acronym
EndothSAS
Enrollment
49
Registered
2015-10-09
Start date
2014-03-24
Completion date
2017-06-06
Last updated
2018-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Disease in Obstructive Sleep Apnea

Keywords

obstructive sleep apnea, endothelial dysfunction, periodontitis

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.

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

Sponsors

Hopital Foch
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Endothelial function20 weeksmeasure of Reactive Hyperemia- Peripheral Artery Tone index with Endopat

Secondary

MeasureTime frameDescription
Endothelial function10 weeksmeasure of Reactive Hyperemia- Peripheral Artery Tone index with Endopat
blood biomarkers0, 10 and 20 weekshsCRP, leptin, adiponectin, E-selectin and orosomucoid
Epworth Sleepiness Scale0, 10 and 20 weeks

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026