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

Hopital Foch

Status: Terminated

Conditions: Cardiovascular Disease in Obstructive Sleep Apnea

Treatments: Procedure: scaling and root planing

Study type: Interventional

Funder types: Other

Identifiers

NCT02573116

2013/44

Details and patient eligibility

About

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.

Full 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.

Enrollment: 49 patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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49 participants in 2 patient groups

Obstructive sleep apnea with chronic parodontis

Experimental group

Description:

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

Treatment:

Procedure: scaling and root planing

Obstructive sleep apnea without chronic parodontis

No Intervention group

Description:

patients with severe OSA treated by CPAP