Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 1:17 PM
Study NCT ID:
NCT07421960
Status:
RECRUITING
Last Update Posted:
2026-02-19
First Post:
2026-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation of the Relationship Between Periodontitis and Sleep Quality
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010518', 'term': 'Periodontitis'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}, {'id': 'D005221', 'term': 'Fatigue'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-02-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-05-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-12', 'studyFirstSubmitDate': '2026-02-12', 'studyFirstSubmitQcDate': '2026-02-12', 'lastUpdatePostDateStruct': {'date': '2026-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pittsburgh Sleep Quality Index (PSQI) score', 'timeFrame': 'At baseline (single visit)', 'description': "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.\n\nThe 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"}, {'measure': 'Multidimensional Assessment of Fatigue (MAF) Scale', 'timeFrame': 'At baseline (single visit)', 'description': "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).\n\nItems 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.\n\nIn the scori"}, {'measure': 'Clinical Attachment Level (mm)', 'timeFrame': 'At baseline (single visit)', 'description': '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.\n\nIn 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.'}, {'measure': 'Salivary pentraxin-3 levels', 'timeFrame': 'Baseline', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Plaque percentage', 'timeFrame': 'At baseline (single visit)', 'description': '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%).'}, {'measure': 'Gingival Index', 'timeFrame': 'At baseline (single visit)', 'description': '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.'}, {'measure': 'Probing Pocket Depth', 'timeFrame': 'At baseline (single visit)', 'description': '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.'}, {'measure': 'Bleeding on Probing', 'timeFrame': 'At baseline (single visit)', 'description': '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%).'}, {'measure': 'Salivary interleukin-10 (IL-10) levels', 'timeFrame': 'Baseline', 'description': '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.'}, {'measure': 'Salivary interleukin-6 (IL-6) levels', 'timeFrame': 'Baseline', 'description': '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.'}, {'measure': 'Plaque Index', 'timeFrame': 'At baseline (single visit)', 'description': 'Plaque index is a clinical measure used to assess the thickness and amount of dental plaque accumulated on tooth surfaces.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['IL-6', 'IL-10', 'pentraxin', 'periodontitis', 'sleep quality'], 'conditions': ['Periodontitis', 'Periodontal Disease', 'Sleep Quality', 'Fatigue']}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': '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.\n\nParticipants 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.\n\nIn 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.\n\nThe 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '48', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* systemically healthy,\n* clinical diagnosis of periodontitis,\n* clinical diagnosis of periodontal health\n\nExclusion Criteria:\n\n* history of regular use of systemic antibiotics, anti-inflammatory, or antioxidant drugs (previous 6 months);\n* nonsurgical periodontal treatment (previous 6 months);\n* surgical periodontal treatment (previous 12 months);\n* presence of \\<20 teeth;\n* current medications affecting gingival health (calcium channel blockers, phenytoin, cyclosporine, and hormone replacement therapy);\n* diabetes diagnosis; rheumatoid arthritis diagnosis; and pregnancy, lactating, or excessive alcohol consumption.'}, 'identificationModule': {'nctId': 'NCT07421960', 'acronym': 'RBPSQ', 'briefTitle': 'Investigation of the Relationship Between Periodontitis and Sleep Quality', 'organization': {'class': 'OTHER', 'fullName': 'Uskudar University'}, 'officialTitle': 'An Evaluation of the Relationship Between Sleep Quality and Periodontitis', 'orgStudyIdInfo': {'id': 'ASARIKAYA'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Case Group', 'description': '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.', 'interventionNames': ['Diagnostic Test: Periodontal examinations', 'Diagnostic Test: Collection of saliva samples', 'Diagnostic Test: Pittsburgh Sleep Quality Index', 'Diagnostic Test: (Multidimensional Assessment of Fatigue']}, {'label': 'Control Group', 'description': '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.', 'interventionNames': ['Diagnostic Test: Periodontal examinations', 'Diagnostic Test: Collection of saliva samples', 'Diagnostic Test: Pittsburgh Sleep Quality Index', 'Diagnostic Test: (Multidimensional Assessment of Fatigue']}], 'interventions': [{'name': 'Periodontal examinations', 'type': 'DIAGNOSTIC_TEST', 'description': '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.', 'armGroupLabels': ['Case Group', 'Control Group']}, {'name': 'Collection of saliva samples', 'type': 'DIAGNOSTIC_TEST', 'description': 'Levels of salivary interleukin-10 (IL-10), interleukin-6 (IL-6), pentraxin-3 will be determined using an enzyme-linked immunosorbent assay (ELISA).', 'armGroupLabels': ['Case Group', 'Control Group']}, {'name': 'Pittsburgh Sleep Quality Index', 'type': 'DIAGNOSTIC_TEST', 'description': '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.', 'armGroupLabels': ['Case Group', 'Control Group']}, {'name': '(Multidimensional Assessment of Fatigue', 'type': 'DIAGNOSTIC_TEST', 'description': "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.\n\nThe 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.", 'armGroupLabels': ['Case Group', 'Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34764', 'city': 'Istanbul', 'state': 'Istanbul', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Ayşegül Ayça SARIKAYA', 'role': 'CONTACT', 'email': 'aysegulaycas@gmail.com', 'phone': '+905050951478'}, {'name': 'Kubra KARADURAN', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ayşegül Ayça Sarıkaya', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Uskudar University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Ayşegül Ayça Sarıkaya, Principal Investigator', 'role': 'CONTACT', 'email': 'aysegulaycas@gmail.com', 'phone': '+905050951478'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uskudar University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ayşegül Ayça Sarıkaya', 'investigatorAffiliation': 'Uskudar University'}}}}