Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2026-01-02 @ 1:11 AM
Study NCT ID:
NCT05389969
Status:
COMPLETED
Last Update Posted:
2022-05-25
First Post:
2022-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficiency Of Different Intraoral Scanning Techniques In Orthodontic Patients Before And After Brackets Positioning: A Cross Sectional Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-24', 'studyFirstSubmitDate': '2022-05-20', 'studyFirstSubmitQcDate': '2022-05-24', 'lastUpdatePostDateStruct': {'date': '2022-05-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of repeatability between in-vivo and ex-vivo scans', 'timeFrame': '2 to 3 weeks'}], 'secondaryOutcomes': [{'measure': 'The effect of the type of the scanner on the scanning quality.', 'timeFrame': '2 to 3 weeks'}, {'measure': 'The effect of the bracket presence on the scanning quality.', 'timeFrame': '2 to 3 weeks'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Digital Orthodontics']}, 'descriptionModule': {'briefSummary': 'A Cross-sectional study, in which we compare the efficiency of different scanning techniques in orthodontic patients before and after brackets positioning.\n\nScanning of the maxillary and mandibular dental arch will be performed for the same group of patients twice. The first time is before bracket positioning using two different scanners and the three different techniques. The second time is after brackets positioning using the same two different scanners and the same three different scanning techniques.\n\nThen these scans will be compared to by superimposition techniques and linear measurement techniques.', 'detailedDescription': 'In this study two scanners will be utilized Medit i500 and Trios 3. For each scanner three techniques will be used at two different interventions. One before brackets positioning and the other after bracket positioning. American orthodontics ROTH prescription, 0.022 slot metal brackets will be positioned using direct bonding technique.\n\nThree different scanning techniques will be used: buccopalatal technique, S-shaped technique and palatobuccal technique. The buccopalatal technique (A) involves scanning the arch top side starting from the left second molar then run longitudinally to the contra-lateral one. Then go to the buccal side scan from this right side to the contra-lateral side and then palatal scan. Palatal scan done in two steps first was with counterclockwise movement along the palatal vault and then longitudinal movement in postro-anterior direction.\n\nThe S-shaped technique (B) involves scanning the arch starting from the palatal side of the left second molar then moving the scanner tip in alternating palatobuccal and buccopalatal S-shaped movement along the arch to the contra-lateral side. Then scanning the mid area of the palate by longitudinal movement in postro-anterior direction.\n\nThe palatobuccal technique (c) done by scanning the arch top side first starting from the left second molar runs longitudinally to the contralateral side. Then start palatal scanning by moving the scanner tip with circular movement in a clockwise direction across the palatal vault from the right-side second molar then along the palate to the contralateral second molar. Then the same circular scanning but in the counterclockwise direction to record the remaining part of the palate staring from the left second molar to the contralateral one. The buccal scan will follow starting from the right second molar then run longitudinally to the contralateral side.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '20 Years', 'minimumAge': '15 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adolescent patients with Fully erupted permanent dentition from second molar to the contra lateral second molar in both jaws.', 'eligibilityCriteria': 'Inclusion Criteria:\n\nAdolescent patients.\n\nFully erupted permanent dentition from second molar to the contra lateral second molar in both jaws.\n\nExclusion Criteria:\n\nSevere degree of malocclusion that prevent full arch bracket positioning\n\nDento-facial deformity such as cleft lip/ palate or cranio-facial syndrome.\n\nSevere Skeletal discrepancy in any of the three planes of space.\n\nTMD problem\n\nLimited mouth opening\n\nPresence of crowns or bridges.'}, 'identificationModule': {'nctId': 'NCT05389969', 'briefTitle': 'Efficiency Of Different Intraoral Scanning Techniques In Orthodontic Patients Before And After Brackets Positioning: A Cross Sectional Study', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Efficiency Of Different Intraoral Scanning Techniques In Orthodontic Patients Before And After Brackets Positioning: A Cross Sectional Study', 'orgStudyIdInfo': {'id': '14422020488903'}}, 'armsInterventionsModule': {'interventions': [{'name': 'digital arch scanning', 'type': 'OTHER', 'description': 'Scanning of the maxillary and mandibular dental arch will be performed for the same group of patients twice. The first time is before bracket positioning using two different scanners and the three different techniques. The second time is after brackets positioning using the same two different scanners and the same three different scanning techniques.\n\nThen these scans will be compared to by superimposition techniques and linear measurement techniques.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '12613', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': "Master's degree student Cairo university", 'investigatorFullName': 'Mostafa Karam Salim', 'investigatorAffiliation': 'Cairo University'}}}}