Periodontal Disease in Patients With Obstructive Sleep Apnea

January 26, 2022 updated by: I.M. Sechenov First Moscow State Medical University

Attachment Loss Levels, Periodontal Indices, and Sulcus Bleeding Indices in Patients With Obstructive Sleep Apnea: a Cross-sectional Study

Investigators hypothesize that in patients with obstructive sleep apnea (OSA) the severity of periodontal disease is significantly higher compared to patients without OSA in every aspect, including PI, PD, CAL and BOP. The number of lost teeth is hypothesized to be also higher in patients with obstructive sleep apnea.

Purpose: evaluation of periodontal status in patients with obstructive sleep apnea.

An analytical cross-sectional study will be conducted at the Department of Therapeutic Dentistry of the Sechenov University, Moscow.

Investigators are planning to recruit 100 patients: 1) patients with OSA confirmed by polysomnography -75 participants aged between 35 and 65; 2) patients without OSA -25 participants of a similar age.

Patients with obstructive sleep apnea syndrome will be sub-divided into three sub-groups according to OSA severity: 2A group - patients with mild apnea severity; 2B group - patients with medium apnea severity; 2C group - patients with severe apnea.

All participants will undergo a dental examination including the following parameters: plaque index (PI; Silness & Loe, 1964), bleeding on probing (BOP), and touch depth of the pocket (PD), the level of clinical attachment loss (CAL). Investigators will also evaluate the number of lost teeth.

Study Overview

Status

Completed

Conditions

Detailed Description

Periodontal disease is a chronic inflammatory disease which is associated with an increased risk of many diseases, including bone and cardiovascular disease (Adamkiewicz et al., 2018). The high prevalence and severity of periodontal inflammatory diseases is a current problem in dentistry. A growing body of literature suggests that there is a link between periodontitis and systemic diseases. Nevertheless a cause-and-effect relationship has not been established yet for most of the diseases, and the mediators of the association are still being identified (Bui et al., 2019). In recent years, several studies have revealed a possible link between periodontitis and obstructive sleep apnea (OSA). The main oral symptom of OSA is dry mouth due to oral breathing, which is a significant risk factor for periodontal disease. Chronic periodontitis is characterized by the destruction of the supporting tissues of the teeth through complex cascades of inflammatory responses, and OSA seems to share common pathways, acting synergistically (Ryan Price et al., 2020).

The purpose of the study is to evaluate the periodontal health in patients with obstructive sleep apnea (OSA).

Within an analytical cross-sectional study 150 patients will be examined: 75 patients with obstructive sleep apnoea and 25 patients without OSA.

The diagnosis of sleep apnea will be set after the standard polysomnography in the Domino program. The severity of OSA will be determined according to AHI index.

Patients with obstructive sleep apnea syndrome will be sub-divided into three groups according to sleep apnea severity: 2A group - patients with mild sleep apnea severity; 2B group - patients with medium sleep apnea severity; 3С group - patients with severe sleep apnea.

After confirming the diagnosis of obstructive sleep apnea patients undergo dental examination. Investigators will use a manual periodontal probe to provide basic periodontal examination.

The amount of plaque accumulated in cervical part of the teeth will be registered by the plaque index (PI; Silness & Loe, 1964). The activity of the inflammation will be assessed with use of Bleeding on probing index (BOP). The Pocket Touch Depth (PD) will and the level of clinical attachment loss (CAL) will be recorded. The number of lost teeth will also be estimated.

Potential risk factors for periodontal disease will also be evaluated (body weight index (BMI), smoker status).

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

33 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients of the Somnology Center, healthy volunteers recruited from Sechenov University staff.

Description

Inclusion Criteria:

Patients with obstructive sleep apnea

Exclusion Criteria:

Pregnancy and lactation diabetes mellitus coronary heart disease medications associated with xerostomia chronic infectious diseases.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
OSA
Patients with OSA confirmed by polysomnography, aged 35-65
Non-OSA
Patients without OSA aged 35-65

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical attachment loss (CAL)
Time Frame: baseline

distance from the cemento-enamel junction (CEJ) to the base of the clinical pocket.

Measurement takes place with a periodontal probe. Taken together, the probing depth plus the distance from the gingival margin to the CEJ comprises the clinical attachment level
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
bleeding on probing (BOP index)
Time Frame: baseline
presence or abscence of bleeding within 10 seconds after probing.
baseline
pocket depth (PD)
Time Frame: baseline
Measure the pocket depth of the groove between your gums and teeth by placing a dental probe beside your tooth beneath your gumline, usually at several sites throughout your mouth.
baseline
Silness-Loe plaque index (PI).
Time Frame: baseline
Each of the four surfaces of the teeth (buccal, lingual, mesial and distal) is given a score from 0-3. The indices for the following six teeth may be grouped to designate the index for the group of teeth: 16, 12, 24, 36, 32, 44. The index for the patient is obtained by summing the indices for all six teeth and dividing by six.
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

I.M. Sechenov First Moscow State Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 12, 2021

Primary Completion (Actual)

January 15, 2022

Study Completion (Actual)

January 15, 2022

Study Registration Dates

First Submitted

September 24, 2020

First Submitted That Met QC Criteria

October 3, 2020

First Posted (Actual)

October 9, 2020

Study Record Updates

Last Update Posted (Actual)

February 9, 2022

Last Update Submitted That Met QC Criteria

January 26, 2022

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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