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

NCT02573116 | Terminated

• 1 other identifier: 2013/44
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Disease in Obstructive Sleep Apnea

Keywords

obstructive sleep apnea; endothelial dysfunction; periodontitis

Outcome Measures

Primary Outcomes (1)

• Endothelial function

  measure of Reactive Hyperemia- Peripheral Artery Tone index with Endopat

  20 weeks

Secondary Outcomes (3)

• Endothelial function

  10 weeks

• blood biomarkers

  0, 10 and 20 weeks

• Epworth Sleepiness Scale

  0, 10 and 20 weeks

Study Arms (2)

Obstructive sleep apnea with chronic parodontis

EXPERIMENTAL

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

Obstructive sleep apnea without chronic parodontis

NO INTERVENTION

patients with severe OSA treated by CPAP

Interventions

scaling and root planing PROCEDURE

full-mouth intensive removal of subgingival dental plaque biofilms with the use of scaling and root planing after the administration of local anesthesia

Obstructive sleep apnea with chronic parodontis

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hopital Foch: lead

Study Sites (1)

Hôpital Foch

Suresnes, 92150, France

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Periodontitis

Interventions

Tooth Exfoliation; Root Planing

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Dental Scaling; Dental Prophylaxis; Periodontics; Dentistry; Subgingival Curettage; Preventive Dentistry

Study Officials

• Priscilla Henno, MD

  AP-HP, Hôpital Européen Georges Pompidou

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2015
• First Posted: October 9, 2015
• Study Start: March 24, 2014
• Primary Completion: December 22, 2016
• Study Completion: June 6, 2017
• Last Updated: October 3, 2018

Record last verified: 2018-10

Locations

FR (1)