Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2026-01-29 @ 8:28 AM
Study NCT ID:
NCT03611920
Status:
COMPLETED
Last Update Posted:
2018-08-21
First Post:
2018-07-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Topical Tetracycline and Dexamethasone on Periodontal and Pulpal Regeneration of Replanted Avulsed Teeth
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000071562', 'term': 'Fractures, Avulsion'}], 'ancestors': [{'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013752', 'term': 'Tetracycline'}, {'id': 'D003907', 'term': 'Dexamethasone'}], 'ancestors': [{'id': 'D013754', 'term': 'Tetracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-08-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2017-10-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-20', 'studyFirstSubmitDate': '2018-07-27', 'studyFirstSubmitQcDate': '2018-07-27', 'lastUpdatePostDateStruct': {'date': '2018-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-10-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of teeth with periodontal regeneration', 'timeFrame': 'After a mean observation period of 12.9±2.4 years (one visit only)', 'description': 'Periodontal regeneration was assessed with periodontal examination, percussion, Periotest measurements and periapical radiograph.'}, {'measure': 'Number of teeth with pulpal regeneration', 'timeFrame': 'After a mean observation period of 12.9±2.4 years (one visit only)', 'description': 'Pulpal regeneration was assessed with periodontal examination, percussion, Periotest measurements, pulp sensitivity using CO2 snow and periapical radiograph.'}], 'secondaryOutcomes': [{'measure': 'Number of teeth that survived', 'timeFrame': 'After a mean observation period of 12.9±2.4 years (one visit only)', 'description': 'Assessed by visual inspection'}, {'measure': 'Number of teeth with open versus closed apex at accident', 'timeFrame': 'At baseline', 'description': 'Assessed by x-ray'}, {'measure': 'Patients satisfaction', 'timeFrame': 'After a mean observation period of 12.9±2.4 years (one visit only)', 'description': 'Measured by OHIP-14 score'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dental Trauma', 'Avulsion', 'Periodontal Regeneration', 'Pulpal Regeneration', 'Topical Dexamethasone', 'Topical Tetracycline']}, 'descriptionModule': {'briefSummary': 'To evaluate the effect of topical tetracycline and dexamethasone on periodontal and pulpal regeneration of avulsed permanent teeth after an observation period between 9-16 years.', 'detailedDescription': 'Two different medications were applied prior to replantation. A) Topical tetracycline, B) topical dexamethasone. Teeth were splinted using a non-rigid titanium trauma splint for 7-14 days. Endodontic treatment was performed within 1-7 days, except for teeth with an open apex and a short extraoral dry time. All patients received systemic tetracycline for 10 days after accident and were subsequently re-examined.\n\nFollow-up examinations included periodontal examination, percussion, Periotest measurements, pulp sensitivity using CO2 snow, periapical radiograph and intraoral photographs. Additionally a OHIP-14 questionnaire was carried out to determine the oral health-related quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '6 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with avulsed permanent teeth who were treated between 2000-2008 at the Department of Oral Surgery, zmk Bern', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Avulsion of a permanent tooth\n* Written informed consent\n\nExclusion Criteria:\n\n* Extended dry period of more than 60 minutes'}, 'identificationModule': {'nctId': 'NCT03611920', 'briefTitle': 'Effect of Topical Tetracycline and Dexamethasone on Periodontal and Pulpal Regeneration of Replanted Avulsed Teeth', 'organization': {'class': 'OTHER', 'fullName': 'University of Bern'}, 'officialTitle': 'Effect of Topical Tetracycline and Dexamethasone on Periodontal and Pulpal Regeneration of Replanted Avulsed Permanent Teeth: A Long-term Follow-up After 9-16 Years', 'orgStudyIdInfo': {'id': 'KEK: 2016-00383'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Tetracycline', 'description': 'Teeth were soaked in topical tetracycline 5% for 5 minutes before replantation', 'interventionNames': ['Procedure: Tetracycline']}, {'label': 'Dexamethasone', 'description': 'Teeth were soaked in dexamethasone (60μ ml-1) for 20 minutes before replantation', 'interventionNames': ['Procedure: Dexamethasone']}], 'interventions': [{'name': 'Tetracycline', 'type': 'PROCEDURE', 'description': 'Teeth were soaked in topical tetracycline 5% for 5 minutes before replantation', 'armGroupLabels': ['Tetracycline']}, {'name': 'Dexamethasone', 'type': 'PROCEDURE', 'description': 'Teeth were soaked in topical dexamethasone (60μ ml-1) for 20 minutes before replantation', 'armGroupLabels': ['Dexamethasone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3010', 'city': 'Bern', 'country': 'Switzerland', 'facility': 'zmk Bern', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}], 'overallOfficials': [{'name': 'Vivianne Chappuis, PD Dr.', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Oral Surgery and Stomatology, zmk Bern, University Bern'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Bern', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}