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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cardiovascular Disease in Obstructive Sleep Apnea

Intervention / Treatment
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* Procedure: scaling and root planing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Obstructive sleep apnea with chronic parodontis<br>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<br>* full-mouth intensive removal of subgingival dental plaque biofilms with the use of scaling and root planing after the administration of local anesthesia<br>|
| No Intervention: Obstructive sleep apnea without chronic parodontis<br>patients with severe OSA treated by CPAP | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obstructive sleep apnea, endothelial dysfunction, periodontitis