Ignite Creation Date:
2025-12-25 @ 3:10 AM
Ignite Modification Date:
2026-01-01 @ 2:09 AM
Study NCT ID:
NCT04509505
Status:
COMPLETED
Last Update Posted:
2022-03-11
First Post:
2020-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Waterpipe Smoking on Periodontal Health
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073867', 'term': 'Water Pipe Smoking'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}], 'ancestors': [{'id': 'D000073868', 'term': 'Pipe Smoking'}, {'id': 'D012907', 'term': 'Smoking'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 323}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2021-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-10', 'studyFirstSubmitDate': '2020-08-09', 'studyFirstSubmitQcDate': '2020-08-09', 'lastUpdatePostDateStruct': {'date': '2022-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'periodontal health condition in waterpipe smokers.', 'timeFrame': 'through study completion, an average of 1 year.', 'description': 'will be assessed from questions about smoking habits, including smoking mode as well as duration and extent of use of waterpipe smoking and measuring the CAL for staging the periodontal condition according to the new classification by the aid of radiographic examination.'}], 'secondaryOutcomes': [{'measure': 'Impact of sociodemographic factors on periodontal health', 'timeFrame': 'through study completion, an average of 1 year.', 'description': 'Questions regarding sociodemographic information such as educational level, income and marital status will be analyzed.'}, {'measure': 'Impact of oral hygiene behaviour on periodontal health.', 'timeFrame': 'through study completion, an average of 1 year.', 'description': 'Questions regarding oral health behaviors such as toothbrushing frequency, use of auxiliary aids, dental visits and toothbrushing method will be analyzed too.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Waterpipe Smoking', 'Periodontal Diseases']}, 'referencesModule': {'references': [{'pmid': '16274311', 'type': 'RESULT', 'citation': 'Natto S, Baljoon M, Bergstrom J. Tobacco smoking and periodontal health in a Saudi Arabian population. J Periodontol. 2005 Nov;76(11):1919-26. doi: 10.1902/jop.2005.76.11.1919.'}, {'pmid': '26383198', 'type': 'RESULT', 'citation': 'Alzyoud S, Veeranki SP, Kheirallah KA, Shotar AM, Pbert L. Validation of the Waterpipe Tolerance Questionnaire Among Jordanian School-Going Adolescent Waterpipe Users. Glob J Health Sci. 2015 Jun 25;8(2):198-208. doi: 10.5539/gjhs.v8n2p198.'}, {'pmid': '29963753', 'type': 'RESULT', 'citation': 'Al-Alimi A, Halboub E, Al-Sharabi AK, Taiyeb-Ali T, Jaafar N, Al-Hebshi NN. Independent determinants of periodontitis in Yemeni adults: A case-control study. Int J Dent Hyg. 2018 Nov;16(4):503-511. doi: 10.1111/idh.12352. Epub 2018 Jul 2.'}]}, 'descriptionModule': {'briefSummary': 'The main objective of the study is to assess the effect of waterpipe smoking on periodontal health, which will be done using a well constructed validated questionnaire. Then a full periodontal examination and x-ray evaluation will be done for all of the participants.', 'detailedDescription': 'The primary outcome of the study is to assess the effect of waterpipe smoking on periodontal health, it will be assessed by questions about smoking habits, including smoking mode as well as duration (heads smoked per day) and extent of use (age of initiation and number of sessions per week) of waterpipe smoking.\n\nA full periodontal examination using UNC-15 periodontal probe will be done for all of the participants measuring the CAL, Probing Depth (PD), plaque index (PI), bleeding on probing (BOP) and gingival recession depth (GD). In subjects where attachment loss will be clinically detected, radiographic examination will be performed by digital periapical radiograph to detect the amount of bone loss, then staging will be done according to the new classification by the aid of radiographic examination.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Dental patients will be recruited in a consecutive manner from the outpatient Diagnostic center, Faculty of Dentistry, Cairo University.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients whose age is between 18-60 years old.\n2. Patient consulting in the outpatient clinic.\n3. Provide informed consent.\n\nExclusion Criteria:\n\n1. Individuals with chronic systemic diseases such as diabetes, endocrine and hematological Pathologies.\n2. Patients having problem in opening their mouth or undergoing intermaxillary fixation where oral examination will not be possible.\n3. Pregnant women.\n4. Patients diagnosed with psychiatric problems or intoxicated with alcohol or drugs.\n5. Patients with orthodontic appliances.'}, 'identificationModule': {'nctId': 'NCT04509505', 'briefTitle': 'Effect of Waterpipe Smoking on Periodontal Health', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'The Effect of Waterpipe Smoking on Periodontal Health Among a Sample of Adult Egyptian Patients. A Hospital Based Cross-sectional Study', 'orgStudyIdInfo': {'id': 'Mariam2020'}}, 'contactsLocationsModule': {'locations': [{'zip': '11865', 'city': 'Cairo', 'state': 'Giza Governorate', 'country': 'Egypt', 'facility': 'Faculty of Dentistry, Cairo University'}], 'overallOfficials': [{'name': 'Noha Ayman Ghallab, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Professor of Oral medicine and Periodontology, Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Noha Ayman Ghallab', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr Noha Ayman Ghallab - Professor of Oral Medicine and Periodontology / Cairo University.', 'investigatorFullName': 'Noha Ayman Ghallab', 'investigatorAffiliation': 'Cairo University'}}}}