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

Not Applicable

Terminated

• Conditions: Cardiovascular Disease in Obstructive Sleep Apnea
• Interventions: Procedure: scaling and root planing

• Registration Number: NCT02573116
• Lead Sponsor: Hopital Foch

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.

Study Timeline

• Study Start: 2014-03-24
• Study First Submitted: 2015-10-08
• Study First Submitted QC: 2015-10-08
• Study First Posted: 2015-10-09
• Primary Completion: 2016-12-22
• Study Completion: 2017-06-06
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-01
• Last Update Posted: 2018-10-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Obstructive sleep apnea with chronic parodontis	scaling and root planing	patients with severe obstructive sleep apnea (OSA) and chronic parodontis treated for OSA by continuous positive airway pressure (CPAP) and intensive periodontal treatment

Primary Outcome Measures

Name	Time	Method
Endothelial function	20 weeks	measure of Reactive Hyperemia- Peripheral Artery Tone index with Endopat

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hôpital Foch; 🇫🇷 Suresnes, France