Clinical trial NCT04581798: Periodontal Disease in Patients With Obstructive Sleep Apnea
Official title: Attachment Loss Levels, Periodontal Indices, and Sulcus Bleeding Indices in Patients With Obstructive Sleep Apnea: a Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Sleep Apnea of Adult
Periodontal Diseases
Periodontal Pocket
Periodontal Attachment Loss
Keywords: Obstructive sleep apnea
Periodontal disease
Periodontal attachment loss
Bleeding on probing
Plaque index
Lead sponsor: I.M. Sechenov First Moscow State Medical University
Sponsor class: OTHER
First posted: 2020-10-09
Enrollment: 100
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of the Somnology Center, healthy volunteers recruited from Sechenov University staff.

Brief summary: 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.

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).

Eligibility criteria: Inclusion Criteria:

Patients with obstructive sleep apnea

Exclusion Criteria:

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

Primary outcomes:
measure: Clinical attachment loss (CAL)
timeFrame: baseline
Secondary outcomes:
measure: bleeding on probing (BOP index)
timeFrame: baseline
measure: pocket depth (PD)
timeFrame: baseline
measure: Silness-Loe plaque index (PI).
timeFrame: baseline
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Sechenov University
Study officials:
References: