PeriodontitisRBPSQNCT07421960
Investigation of the Relationship Between Periodontitis and Sleep Quality
An observational study of Periodontitis and Periodontal Disease, run by Uskudar University at 1 site in Turkey (Türkiye).
Trial summary
This project aims to investigate the relationship between periodontitis and sleep quality. Its originality lies in evaluating the association between periodontal status and sleep quality together with salivary interleukin-6 (IL-6), interleukin-6 (IL-10) IL-10, and pentraxin-3 levels. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Periodontal Disease, Sleep Quality
- What is being tested?
- Periodontal examinations, Collection of saliva samples and Pittsburgh Sleep Quality Index
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Feb 2026to 8 May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 48
Who may be able to join
- systemically healthy,
- clinical diagnosis of periodontitis,
- clinical diagnosis of periodontal health
Who cannot join
- history of regular use of systemic antibiotics, anti-inflammatory, or antioxidant drugs (previous 6 months);
- nonsurgical periodontal treatment (previous 6 months);
- surgical periodontal treatment (previous 12 months);
- presence of <20 teeth;
- current medications affecting gingival health (calcium channel blockers, phenytoin, cyclosporine, and hormone replacement therapy);
- diabetes diagnosis; rheumatoid arthritis diagnosis; and pregnancy, lactating, or excessive alcohol consumption.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Uskudar University
Istanbul, Istanbul, 34764
Ayşegül Ayça SARIKAYA, +905050951478, aysegulaycas@gmail.com
Kubra KARADURAN
About this study
Official title: An Evaluation of the Relationship Between Sleep Quality and Periodontitis
This project aims to investigate the relationship between periodontitis and sleep quality. Its originality lies in evaluating the association between periodontal status and sleep quality together with salivary interleukin-6 (IL-6), interleukin-6 (IL-10) IL-10, and pentraxin-3 levels. In particular, examining the relationship of sleep quality with biological, psychological, and lifestyle factors through periodontitis and salivary IL-6, IL-10, and pentraxin-3 levels has not been previously studied in the literature. Methodologically, periodontal status will be determined through clinical examination; participants' Pittsburgh Sleep Quality Index and Multidimensional Fatigue Inventory scores will be recorded; and salivary IL-6, IL-10, and pentraxin-3 levels will be measured. The obtained data will be compared using statistical analyses to determine the strength of the relationship between periodontitis severity and sleep quality. From a management perspective, the project will be conducted following approval from the ethics committee. In terms of broader impact, the results are expected to scientifically demonstrate the relationship between periodontitis and sleep quality, contribute to the adoption of a holistic health approach in clinical practice, and increase public health awareness. Additionally, the project is expected to provide a foundation for future research on the relationship between oral health and quality of life.
Read the detailed description
This study is designed to investigate the relationship between periodontitis and sleep quality through clinical, questionnaire-based, and biochemical parameters. Periodontitis is a chronic inflammatory disease that may influence systemic health, while sleep quality is closely associated with inflammatory, psychological, and lifestyle-related factors. However, the combined evaluation of periodontal status, sleep quality, and salivary inflammatory biomarkers has not been sufficiently explored.
Participants will undergo a comprehensive periodontal examination, including standard clinical periodontal parameters, to determine periodontal status and disease severity. Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), and fatigue status will be evaluated with the Multidimensional Fatigue Inventory (MFI). These validated instruments will provide quantitative measures of subjective sleep quality and fatigue dimensions.
In addition to clinical and questionnaire data, unstimulated saliva samples will be collected from all participants under standardized conditions. Salivary levels of interleukin-6 (IL-6), interleukin-10 (IL-10), and pentraxin-3 will be measured using appropriate biochemical analysis methods. These biomarkers are selected to reflect inflammatory and immunoregulatory activity potentially linking periodontal disease and sleep disturbances.
The primary objective is to determine whether sleep quality is associated with periodontal disease severity. Secondary objectives include evaluating the relationship between sleep quality scores, fatigue measures, and salivary inflammatory marker levels. Statistical analyses will be performed to assess correlations and group differences among periodontal, sleep, and biomarker variables.
The study will be conducted following ethics committee approval and in accordance with relevant ethical guidelines. Findings are expected to contribute to a better understanding of the biological and behavioral links between oral health and sleep quality and to support a more holistic approach in clinical health assessment and preventive care.
- Conditions
- Periodontitis, Periodontal Disease, Sleep Quality, Fatigue
- Being tested
- Periodontal examinations, Collection of saliva samples, Pittsburgh Sleep Quality Index, (Multidimensional Assessment of Fatigue
- Keywords
- IL-6, IL-10, pentraxin, periodontitis, sleep quality
- Medical subject headings
- Periodontitis, Periodontal Diseases, Sleep Initiation and Maintenance Disorders, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periodontal examinationsDiagnostic test
With periodontal evaluation, plaque percentage, probing pocket depth, percentage of bleeding on probing, clinical attachment level, gingival index, plaque index, number of teeth parameters are recorded.
Collection of saliva samplesDiagnostic test
Levels of salivary interleukin-10 (IL-10), interleukin-6 (IL-6), pentraxin-3 will be determined using an enzyme-linked immunosorbent assay (ELISA).
Pittsburgh Sleep Quality IndexDiagnostic test
The Pittsburgh Sleep Quality Index (PSQI) is a standardized self-report tool used to measure sleep quality over the past month. It is widely applied in both clinical and research settings to screen for sleep disorders, evaluate sleep quality in healthy and patient populations, and analyze sleep-related factors. The scale includes questions on sleep habits, frequency of sleep problems, and overall sleep quality. It assesses multiple dimensions: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Each item is rated on a four-point frequency scale. Total scores range from 0 to 21, with higher scores indicating poorer sleep quality; scores of 5 or more suggest poor sleep quality. The PSQI is considered a valid and reliable multidimensional assessment instrument.
(Multidimensional Assessment of FatigueDiagnostic test
The MAF Scale (Multidimensional Assessment of Fatigue) is a self-reported instrument developed to evaluate individuals' fatigue experiences over the past seven days, based on personal perceptions. It consists of 16 items and can be administered in a short time. The scale covers five dimensions: degree of fatigue (item 1), severity (item 2), distress caused by fatigue (item 3), impact on activities of daily living (items 4-14), and timing/frequency (items 15-16). Items 1-14 use a 1-10 numerical rating format, while items 15-16 are multiple-choice. Participants may mark a separate option for activities they did not perform due to reasons other than fatigue; such items are excluded from scoring.
The MAF scale is particularly used for multidimensional assessment of fatigue in chronic diseases. In clinical research, it is used to monitor the effects of treatment or rehabilitation interventions on fatigue, to evaluate symptom changes during patient follow-up, and to assess quality of life.
| Study group | Role | What they receive |
|---|---|---|
| Case Group | Within the scope of this study, individuals aged between 18 and 65 years, who are systemically healthy, have at least 20 natural teeth, and have periodontitis will be included. Receives: Diagnostic Test: Periodontal examinations; Diagnostic Test: Collection of saliva samples; Diagnostic Test: Pittsburgh Sleep Quality Index; Diagnostic Test: (Multidimensional Assessment of Fatigue | |
| Control Group | Within the scope of this study, individuals aged between 18 and 65 years, who are systemically healthy, have at least 20 natural teeth, and do not have periodontal disease will be included. Receives: Diagnostic Test: Periodontal examinations; Diagnostic Test: Collection of saliva samples; Diagnostic Test: Pittsburgh Sleep Quality Index; Diagnostic Test: (Multidimensional Assessment of Fatigue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pittsburgh Sleep Quality Index (PSQI) score
The Pittsburgh Sleep Quality Index (PSQI) is a standardized self-report instrument used to evaluate and measure an individual's sleep quality over the past month. It is widely used in both clinical and research settings to identify sleep disturbances in patient populations, assess sleep quality in healthy individuals, and examine various variables related to sleep. The scale consists of 4 questions that assess sleep habits over the past month using time-based responses, 12 questions that measure the frequency of specific sleep problems if present, and 1 question that provides an overall evaluation of sleep quality during the last month.
The PSQI measures sleep quality across multiple dimensions, including subjective sleep quality, sleep latency (time to fall asleep and difficulty initiating sleep), sleep duration, habitual sleep efficiency (the ratio of time spent asleep to time spent in bed), sleep disturbances (such as frequent awakenings, snoring, nocturia, and nightmares), use of
Measured: At baseline (single visit)
Multidimensional Assessment of Fatigue (MAF) Scale
The MAF Scale is a self-report instrument developed to evaluate individuals' fatigue experiences over the past seven days. It is based on personal perception and subjective reporting and can be administered in a short time. The scale consists of 16 items and covers five dimensions: degree of fatigue (item 1), severity (item 2), distress caused by fatigue (item 3), impact on activities of daily living (items 4-14), and timing/frequency (items 15-16).
Items 1-14 use a 1-10 numeric rating format, while items 15-16 are multiple-choice questions. Participants may indicate if they did not perform certain activities for reasons other than fatigue; such items are excluded from scoring. The MAF scale is widely used to provide a multidimensional evaluation of fatigue, particularly in chronic diseases. In clinical research, it is used to monitor the effects of treatment or rehabilitation on fatigue, to evaluate symptom changes during patient follow-up, and to assess quality of life.
In the scori
Measured: At baseline (single visit)
Clinical Attachment Level (mm)
Clinical attachment level (CAL) is a more reliable indicator of periodontal support around a tooth than probing depth alone, as it is measured from a fixed anatomical landmark-the cementoenamel junction (CEJ)-which remains constant over time. Calculating CAL requires two measurements: the distance from the gingival margin to the CEJ and the probing depth.
In cases of gingival recession, CAL is calculated by adding the probing depth to the distance from the gingival margin to the CEJ. In cases of gingival overgrowth, CAL is determined by subtracting the distance from the gingival margin to the CEJ from the probing depth.
Measured: At baseline (single visit)
Salivary pentraxin-3 levels
Salivary pentraxin levels. Saliva samples will be collected prior to clinical periodontal measurements. The collected saliva samples will be stored at -80°C until analysis. Pentraxin levels in saliva will be measured using the ELISA method.
Measured: Baseline
Secondary outcomes (7)
Plaque percentage
The presence or absence of plaque is determinant, recorded as (+) in the presence of plaque or (-) in the absence of plaque, and the percentage of the entire mouth afected by plaque is expressed as a percentage (P%).
Measured: At baseline (single visit)
Gingival Index
Assessed following plaque index measurement, this index evaluates inflammation and bleeding at four sites per tooth (mesial, mid, distal vestibular, and lingual/palatal). Scoring is as follows: 0 = no visible inflammation; 1 = slight change in gingival color and texture; 2 = visible inflammation with bleeding tendency upon gentle probing of the sulcus; 3 = marked inflammation with spontaneous bleeding tendency. The gingival index is calculated as the sum of scores divided by the number of examined surfaces.
Measured: At baseline (single visit)
Probing Pocket Depth
Measurement of the depth of a sulcus or periodontal pocket determined by measuring distance from a gingival margin to the base of the sulcus or pocket with a calibrated periodontal probe.
Measured: At baseline (single visit)
Bleeding on Probing
The number obtained by dividing the sum of the positive areas by the sum of the examined areas is multiplied by 100 and the value obtained is expressed as the percentage of bleeding at probing (BOP%).
Measured: At baseline (single visit)
Salivary interleukin-10 (IL-10) levels
Saliva samples will be collected prior to clinical periodontal measurements. The collected saliva samples will be stored at -80°C until analysis. Il-10 levels in saliva will be measured using the enzyme-linked immunosorbent assay (ELISA) method.
Measured: Baseline
Salivary interleukin-6 (IL-6) levels
Salivary interleukin-6 (IL-6) levels. Saliva samples will be collected prior to clinical periodontal measurements. The collected saliva samples will be stored at -80°C until analysis. Il-6 levels in saliva will be measured using the enzyme-linked immunosorbent assay (ELISA) method.
Measured: Baseline
Plaque Index
Plaque index is a clinical measure used to assess the thickness and amount of dental plaque accumulated on tooth surfaces.
Measured: At baseline (single visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start10 Feb 2026
- Primary completion3 Apr 2026 (estimated)
- Study completion8 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies 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
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uskudar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşegül Ayça Sarıkaya, Uskudar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07421960
- Sponsor's protocol ID
- ASARIKAYA
- Acronym
- RBPSQ
- Status last verified
- Feb 2026
- First submitted
- 12 Feb 2026
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the Relationship Between Sleep Quality and Periodontitis
- ClinicalTrials.gov ID
- NCT07421960
- Acronym / sponsor ID
- RBPSQ / ASARIKAYA
- Conditions
- Periodontitis, Periodontal Disease, Sleep Quality, Fatigue
- Keywords
- IL-6, IL-10, pentraxin, periodontitis, sleep quality
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Uskudar UniversityUniversity, hospital or other
- Study start
- 10 Feb 2026 (actual)
- Primary completion
- 3 Apr 2026 (estimated)
- Study completion
- 8 May 2026 (estimated)
- First posted
- 19 Feb 2026 (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.
This project aims to investigate the relationship between periodontitis and sleep quality. Its originality lies in evaluating the association between periodontal status and sleep quality together with salivary interleukin-6 (IL-6), interleukin-6 (IL-10) IL-10, and pentraxin-3 levels. In particular, examining the relationship of sleep quality with biological, psychological, and lifestyle factors through periodontitis and salivary IL-6, IL-10, and pentraxin-3 levels has not been previously studied in the literature. Methodologically, periodontal status will be determined through clinical examination; participants' Pittsburgh Sleep Quality Index and Multidimensional Fatigue Inventory scores will be recorded; and salivary IL-6, IL-10, and pentraxin-3 levels will be measured. The obtained data will be compared using statistical analyses to determine the strength of the relationship between periodontitis severity and sleep quality. From a management perspective, the project will be conducted following approval from the ethics committee. In terms of broader impact, the results are expected to scientifically demonstrate the relationship between periodontitis and sleep quality, contribute to the adoption of a holistic health approach in clinical practice, and increase public health awareness. Additionally, the project is expected to provide a foundation for future research on the relationship between oral health and quality of life.
Detailed description
This study is designed to investigate the relationship between periodontitis and sleep quality through clinical, questionnaire-based, and biochemical parameters. Periodontitis is a chronic inflammatory disease that may influence systemic health, while sleep quality is closely associated with inflammatory, psychological, and lifestyle-related factors. However, the combined evaluation of periodontal status, sleep quality, and salivary inflammatory biomarkers has not been sufficiently explored.
Participants will undergo a comprehensive periodontal examination, including standard clinical periodontal parameters, to determine periodontal status and disease severity. Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), and fatigue status will be evaluated with the Multidimensional Fatigue Inventory (MFI). These validated instruments will provide quantitative measures of subjective sleep quality and fatigue dimensions.
In addition to clinical and questionnaire data, unstimulated saliva samples will be collected from all participants under standardized conditions. Salivary levels of interleukin-6 (IL-6), interleukin-10 (IL-10), and pentraxin-3 will be measured using appropriate biochemical analysis methods. These biomarkers are selected to reflect inflammatory and immunoregulatory activity potentially linking periodontal disease and sleep disturbances.
The primary objective is to determine whether sleep quality is associated with periodontal disease severity. Secondary objectives include evaluating the relationship between sleep quality scores, fatigue measures, and salivary inflammatory marker levels. Statistical analyses will be performed to assess correlations and group differences among periodontal, sleep, and biomarker variables.
The study will be conducted following ethics committee approval and in accordance with relevant ethical guidelines. Findings are expected to contribute to a better understanding of the biological and behavioral links between oral health and sleep quality and to support a more holistic approach in clinical health assessment and preventive care.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case Group | – | Diagnostic Test: Periodontal examinations, Diagnostic Test: Collection of saliva samples, Diagnostic Test: Pittsburgh Sleep Quality Index, Diagnostic Test: (Multidimensional Assessment of FatigueWithin the scope of this study, individuals aged between 18 and 65 years, who are systemically healthy, have at least 20 natural teeth, and have periodontitis will be included. |
| Control Group | – | Diagnostic Test: Periodontal examinations, Diagnostic Test: Collection of saliva samples, Diagnostic Test: Pittsburgh Sleep Quality Index, Diagnostic Test: (Multidimensional Assessment of FatigueWithin the scope of this study, individuals aged between 18 and 65 years, who are systemically healthy, have at least 20 natural teeth, and do not have periodontal disease will be included. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 48
Key inclusion criteria (3 listed)
- systemically healthy,
- clinical diagnosis of periodontitis,
- clinical diagnosis of periodontal health
Key exclusion criteria (6 listed)
- history of regular use of systemic antibiotics, anti-inflammatory, or antioxidant drugs (previous 6 months);
- nonsurgical periodontal treatment (previous 6 months);
- surgical periodontal treatment (previous 12 months);
- presence of <20 teeth;
- current medications affecting gingival health (calcium channel blockers, phenytoin, cyclosporine, and hormone replacement therapy);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Periodontal examinationsWith periodontal evaluation, plaque percentage, probing pocket depth, percentage of bleeding on probing, clinical attachment level, gingival index, plaque index, number of teeth parameters are recorded. | Diagnostic test | Case Group, Control Group |
| Collection of saliva samplesLevels of salivary interleukin-10 (IL-10), interleukin-6 (IL-6), pentraxin-3 will be determined using an enzyme-linked immunosorbent assay (ELISA). | Diagnostic test | Case Group, Control Group |
| Pittsburgh Sleep Quality IndexThe Pittsburgh Sleep Quality Index (PSQI) is a standardized self-report tool used to measure sleep quality over the past month. It is widely applied in both clinical and research settings to screen for sleep disorders, evaluate sleep quality in healthy and patient populations, and analyze sleep-related factors. The scale includes questions on sleep habits, frequency of sleep problems, and overall sleep quality. It assesses multiple dimensions: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Each item is rated on a four-point frequency scale. Total scores range from 0 to 21, with higher scores indicating poorer sleep quality; scores of 5 or more suggest poor sleep quality. The PSQI is considered a valid and reliable multidimensional assessment instrument. | Diagnostic test | Case Group, Control Group |
| (Multidimensional Assessment of FatigueThe MAF Scale (Multidimensional Assessment of Fatigue) is a self-reported instrument developed to evaluate individuals' fatigue experiences over the past seven days, based on personal perceptions. It consists of 16 items and can be administered in a short time. The scale covers five dimensions: degree of fatigue (item 1), severity (item 2), distress caused by fatigue (item 3), impact on activities of daily living (items 4-14), and timing/frequency (items 15-16). Items 1-14 use a 1-10 numerical rating format, while items 15-16 are multiple-choice. Participants may mark a separate option for activities they did not perform due to reasons other than fatigue; such items are excluded from scoring. The MAF scale is particularly used for multidimensional assessment of fatigue in chronic diseases. In clinical research, it is used to monitor the effects of treatment or rehabilitation interventions on fatigue, to evaluate symptom changes during patient follow-up, and to assess quality of life. | Diagnostic test | Case Group, Control Group |
Primary outcome
Pittsburgh Sleep Quality Index (PSQI) score
Time frame: At baseline (single visit)
The Pittsburgh Sleep Quality Index (PSQI) is a standardized self-report instrument used to evaluate and measure an individual's sleep quality over the past month. It is widely used in both clinical and research settings to identify sleep disturbances in patient populations, assess sleep quality in healthy individuals, and examine various variables related to sleep. The scale consists of 4 questions that assess sleep habits over the past month using time-based responses, 12 questions that measure the frequency of specific sleep problems if present, and 1 question that provides an overall evaluation of sleep quality during the last month. The PSQI measures sleep quality across multiple dimensions, including subjective sleep quality, sleep latency (time to fall asleep and difficulty initiating sleep), sleep duration, habitual sleep efficiency (the ratio of time spent asleep to time spent in bed), sleep disturbances (such as frequent awakenings, snoring, nocturia, and nightmares), use of
Multidimensional Assessment of Fatigue (MAF) Scale
Time frame: At baseline (single visit)
The MAF Scale is a self-report instrument developed to evaluate individuals' fatigue experiences over the past seven days. It is based on personal perception and subjective reporting and can be administered in a short time. The scale consists of 16 items and covers five dimensions: degree of fatigue (item 1), severity (item 2), distress caused by fatigue (item 3), impact on activities of daily living (items 4-14), and timing/frequency (items 15-16). Items 1-14 use a 1-10 numeric rating format, while items 15-16 are multiple-choice questions. Participants may indicate if they did not perform certain activities for reasons other than fatigue; such items are excluded from scoring. The MAF scale is widely used to provide a multidimensional evaluation of fatigue, particularly in chronic diseases. In clinical research, it is used to monitor the effects of treatment or rehabilitation on fatigue, to evaluate symptom changes during patient follow-up, and to assess quality of life. In the scori
Clinical Attachment Level (mm)
Time frame: At baseline (single visit)
Clinical attachment level (CAL) is a more reliable indicator of periodontal support around a tooth than probing depth alone, as it is measured from a fixed anatomical landmark-the cementoenamel junction (CEJ)-which remains constant over time. Calculating CAL requires two measurements: the distance from the gingival margin to the CEJ and the probing depth. In cases of gingival recession, CAL is calculated by adding the probing depth to the distance from the gingival margin to the CEJ. In cases of gingival overgrowth, CAL is determined by subtracting the distance from the gingival margin to the CEJ from the probing depth.
Salivary pentraxin-3 levels
Time frame: Baseline
Salivary pentraxin levels. Saliva samples will be collected prior to clinical periodontal measurements. The collected saliva samples will be stored at -80°C until analysis. Pentraxin levels in saliva will be measured using the ELISA method.
7 secondary outcomes
Plaque percentage
Time frame: At baseline (single visit)
Gingival Index
Time frame: At baseline (single visit)
Probing Pocket Depth
Time frame: At baseline (single visit)
Bleeding on Probing
Time frame: At baseline (single visit)
Salivary interleukin-10 (IL-10) levels
Time frame: Baseline
Salivary interleukin-6 (IL-6) levels
Time frame: Baseline
Plaque Index
Time frame: At baseline (single visit)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
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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.
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 Periodontitis and Periodontal Disease, run by Uskudar University at 1 site in Turkey (Türkiye).
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 3 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 19 Feb 2026. 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ayşegül Ayça Sarıkaya, Principal Investigator (+905050951478, aysegulaycas@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pittsburgh Sleep Quality Index (PSQI) score (time frame: At baseline (single visit)). The study lists 4 primary outcomes in all. 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 19 Feb 2026.