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

Cardiovascular Disease in Obstructive Sleep Apnea Clinical Trial

— EndothSAS  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02573116
• Other study ID #: 2013/44
• Status: Terminated
• Phase: N/A
• Start date: March 24, 2014
• Est. completion date: June 6, 2017

Study information

• Verified date: October 2018
• Source: Hopital Foch
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 49
• Est. completion date: June 6, 2017
• Est. primary completion date: December 22, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Cardiovascular Disease in Obstructive Sleep Apnea
• Cardiovascular Diseases
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Procedure:
• scaling 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

Locations

Country	Name	City	State
France	Hôpital Foch	Suresnes

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endothelial function	measure of Reactive Hyperemia- Peripheral Artery Tone index with Endopat	20 weeks
Secondary	Endothelial function	measure of Reactive Hyperemia- Peripheral Artery Tone index with Endopat	10 weeks
Secondary	blood biomarkers	hsCRP, leptin, adiponectin, E-selectin and orosomucoid	0, 10 and 20 weeks
Secondary	Epworth Sleepiness Scale		0, 10 and 20 weeks