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NCT Number: NCT04581798

Periodontal Disease in Patients With Obstructive Sleep Apnea

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.

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Key information

Conditions

Obstructive Sleep Apnea of Adult Apnea Dyssomnias Mouth Diseases Nervous System Diseases Periodontal Atrophy Periodontal Attachment Loss Periodontal Diseases Periodontal Pocket Periodontitis Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders Stomatognathic Diseases

Age range

35 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sechenov University

Moscow, Russia

About this study

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).

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients with obstructive sleep apnea

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. bleeding on probing (BOP index)

    Time frame: baseline

    presence or abscence of bleeding within 10 seconds after probing.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

I.M. Sechenov First Moscow State Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 9, 2020
Registry last updated
Feb 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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