Obstructive Sleep Apnea of AdultNCT04581798
Periodontal Disease in Patients With Obstructive Sleep Apnea
An observational study of Obstructive Sleep Apnea of Adult and Periodontal Diseases, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Obstructive Sleep Apnea of Adult, Periodontal Diseases, Periodontal Pocket
- How many people
- 100 participants
- Where
- 1 siteRussia
- Study dates
- 12 Apr 2021to 15 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- All sexes
- Adult, Older adult
Study population: Patients of the Somnology Center, healthy volunteers recruited from Sechenov University staff.
Who may be able to join
- Patients with obstructive sleep apnea
Who cannot join
- Pregnancy and lactation diabetes mellitus coronary heart disease medications associated with xerostomia chronic infectious diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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).
- 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
- Medical subject headings
- Periodontal Diseases, Periodontal Pocket, Periodontal Attachment Loss, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| OSA | Patients with OSA confirmed by polysomnography, aged 35-65 | |
| Non-OSA | Patients without OSA aged 35-65 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical attachment loss (CAL)
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
Measured: baseline
Secondary outcomes (3)
bleeding on probing (BOP index)
presence or abscence of bleeding within 10 seconds after probing.
Measured: baseline
pocket depth (PD)
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.
Measured: baseline
Silness-Loe plaque index (PI).
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.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2020
- Study start12 Apr 2021
- Primary completion15 Jan 2022
- Study completion15 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea of AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- I.M. Sechenov First Moscow State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04581798
- Sponsor's protocol ID
- 09-2020
- Status last verified
- Sep 2020
- First submitted
- 24 Sep 2020
- Last updated
- 9 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Attachment Loss Levels, Periodontal Indices, and Sulcus Bleeding Indices in Patients With Obstructive Sleep Apnea: a Cross-sectional Study
- ClinicalTrials.gov ID
- NCT04581798
- Acronym / sponsor ID
- 09-2020
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- I.M. Sechenov First Moscow State Medical UniversityUniversity, hospital or other
- Study start
- 12 Apr 2021 (actual)
- Primary completion
- 15 Jan 2022 (actual)
- Study completion
- 15 Jan 2022 (actual)
- First posted
- 9 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OSA | – | –Patients with OSA confirmed by polysomnography, aged 35-65 |
| Non-OSA | – | –Patients without OSA aged 35-65 |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients of the Somnology Center, healthy volunteers recruited from Sechenov University staff.
Key inclusion criteria (1 listed)
- Patients with obstructive sleep apnea
Key exclusion criteria (1 listed)
- Pregnancy and lactation diabetes mellitus coronary heart disease medications associated with xerostomia chronic infectious diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
3 secondary outcomes
bleeding on probing (BOP index)
Time frame: baseline
pocket depth (PD)
Time frame: baseline
Silness-Loe plaque index (PI).
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2022.
- Individual participant dataSharing planned: No
Related trials for Obstructive Sleep Apnea of Adult
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Use a Breathing Machine (PAP) (VESPER-OSA 1)
Apnea, Sleep Disorders
RecruitingPhase 3
A Study of Eloralintide (LY3841136) in Participants With Obstructive Sleep Apnea and Obesity or Overweight
Sleep Apnea, Obstructive, Obesity
Not yet recruiting
Testing Settings of NovaResp's cMAP® Software During Home PAP Therapy
Obstructive Sleep Apnea
Recruiting
The Effects of Successful OSA Treatment on Memory and AD Biomarkers in Older Adults Study
Obstructive Sleep Apnea, Cognitive Decline
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea of Adult and Periodontal Diseases, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical attachment loss (CAL) (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2022.