Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2026-01-02 @ 7:21 AM
Study NCT ID:
NCT07108751
Status:
COMPLETED
Last Update Posted:
2025-08-07
First Post:
2025-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Association Between Gastroesophageal Reflux Disease (GERD) Severity and Dental Caries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005764', 'term': 'Gastroesophageal Reflux'}, {'id': 'D003731', 'term': 'Dental Caries'}], 'ancestors': [{'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D017001', 'term': 'Tooth Demineralization'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004724', 'term': 'Endoscopy'}], 'ancestors': [{'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-31', 'studyFirstSubmitDate': '2025-07-31', 'studyFirstSubmitQcDate': '2025-07-31', 'lastUpdatePostDateStruct': {'date': '2025-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Decayed, Missing, and Filled Teeth (DMFT) Index', 'timeFrame': '3 months post-procedure', 'description': 'The Decayed, Missing, and Filled Teeth (DMFT) Index was calculated as the sum of decayed, missing, and filled teeth, with scores ranging from 0 to 28 or 32, depending on the total number of teeth present.'}], 'secondaryOutcomes': [{'measure': 'Basic Erosive Wear Examination Index', 'timeFrame': '3 months post-procedure', 'description': 'The Basic Erosive Wear Examination Index was used to evaluate tooth surface erosion, with each of the six oral sextants scored based on the most severely affected tooth surface. Erosive wear was graded from 0 (no erosive wear) to 3 (hard tissue loss of 50 percent or greater of the surface area), with cumulative scores categorized into risk bands ranging from no risk (0-2) to high risk (≥14).'}, {'measure': 'Plaque Index', 'timeFrame': '3 months post-procedure', 'description': 'The Plaque Index was assessed by examining four surfaces per tooth (buccal, lingual, mesial, and distal) and scoring plaque thickness from 0 (no plaque) to 3 (heavy plaque accumulation), with final scores calculated as the total plaque scores divided by the number of surfaces examined.'}, {'measure': 'Salivary analysis', 'timeFrame': '3 months post-procedure', 'description': 'Saliva was accumulated in the mouth without stimulation and expectorated into sterile tubes every 60 seconds for five minutes. Salivary pH was measured immediately using a calibrated digital pH meter with measurements taken for 1-2 seconds in 1-2 mL samples.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastroesophageal Reflux Disease', 'Severity', 'Dental Caries']}, 'descriptionModule': {'briefSummary': 'This study aimed to assess the relationship between gastroesophageal reflux disease (GERD) severity (based on upper gastrointestinal endoscopy) and dental caries severity.', 'detailedDescription': 'Gastroesophageal reflux disease (GERD) is a chronic condition characterized by reflux of stomach acid into the esophagus, with a prevalence reaching 20-30% in many populations. Beyond its gastrointestinal manifestations, GERD may have extraesophageal effects, including oral health disturbances such as dental erosion and caries. Exposure of the oral cavity to gastric acid, especially in patients with severe or nocturnal reflux, may contribute to enamel demineralization, increased tooth decay, and lower salivary pH.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A cross-sectional analytical study was conducted at the Gastrointestinal Endoscopy Unit of the Internal Medicine Department at Tanta University Hospital in Egypt, and the Outpatient Dental Clinic affiliated with Zarqa University Dental Clinics in Jordan between January and June 2025.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-65 years.\n* Both sexes.\n* Diagnosed with Gastroesophageal Reflux Disease (GERD) by endoscopy.\n* Consent to participate.\n\nExclusion Criteria:\n\n* Xerostomia-related disorders.\n* Recent antibiotics (last 4 weeks).\n* Head/neck radiation history.\n* Cognitive impairment affecting consent.\n* Pregnant or lactating women.\n* HbA1c above 6.4%.'}, 'identificationModule': {'nctId': 'NCT07108751', 'briefTitle': 'Association Between Gastroesophageal Reflux Disease (GERD) Severity and Dental Caries', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Association Between Gastroesophageal Reflux Disease (GERD) Severity and Dental Caries: A Cross-Sectional Study', 'orgStudyIdInfo': {'id': '36264PR1280/7/25'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study group', 'description': 'Gastroesophageal reflux disease (GERD) patients.', 'interventionNames': ['Device: Endoscopy']}, {'label': 'Control group', 'description': 'Matched control group.', 'interventionNames': ['Device: Endoscopy']}], 'interventions': [{'name': 'Endoscopy', 'type': 'DEVICE', 'description': 'Endoscopy will be performed to all patient', 'armGroupLabels': ['Control group', 'Study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31527', 'city': 'Tanta', 'state': 'El-Gharbia', 'country': 'Egypt', 'facility': 'Tanta University', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'After the end of study for one year.', 'ipdSharing': 'YES', 'description': 'The data will be available upon a reasonable request from the corresponding author after the end of study for one year.', 'accessCriteria': 'The data will be available upon a reasonable request from the corresponding author.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Internal Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.', 'investigatorFullName': 'Mohamed Abd El-Raouf Tawfik', 'investigatorAffiliation': 'Tanta University'}}}}