Ignite Creation Date:
2025-12-24 @ 2:38 PM
Ignite Modification Date:
2026-01-08 @ 6:49 PM
Study NCT ID:
NCT04848259
Status:
COMPLETED
Last Update Posted:
2021-07-22
First Post:
2021-04-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Honey and Dexamethason on Extraction Healing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077330', 'term': 'Saline Solution'}, {'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D006722', 'term': 'Honey'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2021-06-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-20', 'studyFirstSubmitDate': '2021-04-14', 'studyFirstSubmitQcDate': '2021-04-14', 'lastUpdatePostDateStruct': {'date': '2021-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Interincisal distance', 'timeFrame': 'Preoperative', 'description': 'Distance between upper and lower teeth will be measured in mm by ruler'}, {'measure': 'Interincisal distance', 'timeFrame': 'I day postoperative', 'description': 'Distance between upper and lower teeth will be measured in mm by ruler'}, {'measure': 'Interincisal distance', 'timeFrame': '3rd day postoperative', 'description': 'Distance between upper and lower teeth will be measured in mm by ruler'}, {'measure': 'Interincisal distance', 'timeFrame': '7th day postoperative', 'description': 'Distance between upper and lower teeth will be measured in mm by ruler'}, {'measure': 'Edema', 'timeFrame': 'Preoperative', 'description': 'Measured from angle of mandible to angle of mouth'}, {'measure': 'Edema', 'timeFrame': '1day postoperative', 'description': 'Measured from angle of mandible to angle of mouth'}, {'measure': 'Edema', 'timeFrame': '2nd day postoperative', 'description': 'Measured from angle of mandible to angle of mouth in mm by ruler'}, {'measure': 'Edema', 'timeFrame': '3rd day postoperative', 'description': 'Measured from angle of mandible to angle hof mouth in mm by ruler'}, {'measure': 'Edema', 'timeFrame': '7th day postoperative', 'description': 'Measured from angle of mandible to angle of mouth in mm by ruler'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Impacted Third Molar Tooth']}, 'descriptionModule': {'briefSummary': 'Natural honey and dexamethason will be given before impaction removal then postoperative complications will be evaluated', 'detailedDescription': 'Patient with impacted lower third molar will be selected to this study agording to agent applied preoperative. Group 1 will receive topical honey and Group 2 will receive IV dexamethason. After surgical removal of impacted tooth under local anesthesia postoperative pain mouth opening, and swelling will be evaluated'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* impacted 3rd molar\n* healthy patient No smoking\n\nExclusion Criteria:\n\n* history of smoking Medical disease'}, 'identificationModule': {'nctId': 'NCT04848259', 'briefTitle': 'Effect of Honey and Dexamethason on Extraction Healing', 'organization': {'class': 'OTHER', 'fullName': 'Al-Azhar University'}, 'officialTitle': 'A Novel Therapeutic Approach for Controlling Complications Associated With Impacted Mandibular Third Molar Removal', 'orgStudyIdInfo': {'id': 'Impaction'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'No drug given before surgery', 'interventionNames': ['Drug: Normal saline']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dexamethason', 'description': 'Dexamethason will be given IV before surgery', 'interventionNames': ['Drug: Dexamethasone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Natural honey', 'description': 'Honey will be placed locally after impaction removal', 'interventionNames': ['Drug: Honey']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dexamethason and natural honey', 'description': 'Dexamethason will be given IV before surgery and Honey will be placed locally after impaction removal', 'interventionNames': ['Drug: Dexamethasone and honey']}], 'interventions': [{'name': 'Normal saline', 'type': 'DRUG', 'description': 'Saline will be applied after surgery', 'armGroupLabels': ['Control']}, {'name': 'Dexamethasone', 'type': 'DRUG', 'description': 'Dexamethason will be given IV before surgery', 'armGroupLabels': ['Dexamethason']}, {'name': 'Honey', 'type': 'DRUG', 'description': 'Honey will be applied locally after surgery', 'armGroupLabels': ['Natural honey']}, {'name': 'Dexamethasone and honey', 'type': 'DRUG', 'description': 'Dexamethason will be given IV before surgery and then Honey will be applied locally after surgery', 'armGroupLabels': ['Dexamethason and natural honey']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jeddah', 'country': 'Saudi Arabia', 'facility': 'Vision colleges', 'geoPoint': {'lat': 21.49012, 'lon': 39.18624}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Al-Azhar University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Alaa Altaweel', 'investigatorAffiliation': 'Al-Azhar University'}}}}