Ignite Creation Date:
2025-12-24 @ 11:45 AM
Ignite Modification Date:
2026-01-01 @ 2:02 PM
Study NCT ID:
NCT06125561
Status:
UNKNOWN
Last Update Posted:
2023-11-09
First Post:
2023-11-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Periodontal Health and Its Impact on Oral Health-related Quality of Life Among Diabetes Mellitus Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-11-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-04', 'studyFirstSubmitDate': '2023-11-04', 'studyFirstSubmitQcDate': '2023-11-04', 'lastUpdatePostDateStruct': {'date': '2023-11-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'oral health-related quality of life', 'timeFrame': '1 day', 'description': 'the impact of periodontal health on the oral health-related quality of life'}], 'secondaryOutcomes': [{'measure': 'Clinical attachment loss', 'timeFrame': '1 day', 'description': 'Probing depth and clinical attachment loss will be measured'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus', 'Periodontal Diseases']}, 'descriptionModule': {'briefSummary': 'Periodontal diseases, encompassing a range of inflammatory conditions affecting the supporting structures of the teeth, have long been recognized as a prevalent comorbidity in individuals with diabetes. The severity of periodontal disease is usually documented by research clinicians using clinical parameters such as bleeding on probing (BOP), probing pocket depth (PPD), and clinical.', 'detailedDescription': "Oral health plays a pivotal role in the overall well-being and quality of life of individuals. Any condition affecting oral health can have far-reaching consequences for an individual's daily life.Both periodontitis and diabetes have been reported to have negative impacts on aspects of daily living and health-related quality of life. Evidence suggests that oral health problems can adversely affect an individual's physical functioning, social standing and wellbeing, and that it can be difficult to dissociate oral health from general health with regards to impacts on quality of life. Oral health-related quality of life (OHRQoL) can be assessed using the Oral Health Impact Profile-14 (OHIP-14) questionnaire"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The patient presented at dental department of hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals diagnosed with Diabetes Mellitus for case group, non diabetic patients for control group, Age range between 18 to 60 years, informed consent, Participants with varying degrees of periodontal health\n\nExclusion Criteria:\n\n* Participants with severe systemic illnesses and habits that may significantly affect oral health or quality of life, Individuals with severe cognitive impairment or psychiatric conditions that hinder their ability to participate and provide informed consent.'}, 'identificationModule': {'nctId': 'NCT06125561', 'briefTitle': 'Periodontal Health and Its Impact on Oral Health-related Quality of Life Among Diabetes Mellitus Patients', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Pakistan Institute of Medical Sciences'}, 'officialTitle': 'A Study of Periodontal Health and Its Impact on Oral Health-related Quality of Life Among Diabetes Mellitus Patients', 'orgStudyIdInfo': {'id': '14112023'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Diabetic', 'description': "Diabetic patients with age ranges 18-60 years. Clinical Examination will be performed by CPTIN probe and questionnaire will be filled by participant's.", 'interventionNames': ['Other: Probing depth and Clinical attachment loss']}, {'label': 'Non diabetic', 'description': "Non Diabetic patients with age ranges 18-60 years. Clinical Examination will be performed by CPTIN probe and questionnaire will be filled by participant's.", 'interventionNames': ['Other: Probing depth and Clinical attachment loss']}], 'interventions': [{'name': 'Probing depth and Clinical attachment loss', 'type': 'OTHER', 'description': 'CPTIN probe will be used for the clinical examination', 'armGroupLabels': ['Diabetic', 'Non diabetic']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Islamabad', 'status': 'RECRUITING', 'country': 'Pakistan', 'contacts': [{'name': 'Nosheen sarwar, BDS', 'role': 'CONTACT', 'email': 'nosheensarwar18@gmail.com', 'phone': '03088895652'}], 'facility': 'PIMS', 'geoPoint': {'lat': 33.72148, 'lon': 73.04329}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pakistan Institute of Medical Sciences', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'nosheen sarwar', 'investigatorAffiliation': 'Pakistan Institute of Medical Sciences'}}}}