Ignite Creation Date:
2025-12-24 @ 6:43 PM
Ignite Modification Date:
2025-12-24 @ 6:43 PM
Study NCT ID:
NCT04220957
Status:
COMPLETED
Last Update Posted:
2022-05-19
First Post:
2020-01-03
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Digital Versus Conventional Impression Techniques in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-13', 'studyFirstSubmitDate': '2020-01-03', 'studyFirstSubmitQcDate': '2020-01-04', 'lastUpdatePostDateStruct': {'date': '2022-05-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Patient's preference for either digital or conventional impression techniques", 'timeFrame': '30 minutes', 'description': 'The patient will be asked "If you had to take another impression which one of the 2 impression techniques would you prefer?" The patient will mark on a sheet of paper which one of the 2 impression techniques he/she prefers.'}], 'secondaryOutcomes': [{'measure': 'Comfort during impression taking', 'timeFrame': '15 minutes', 'description': 'VAS (Visual Analogue Scale) from 0 to 10 with 0 corresponding to "very uncomfortable" and 10 corresponding to "maximum comfort"'}, {'measure': 'Pain during impression taking', 'timeFrame': '15 minutes', 'description': 'VAS (Visual Analogue Scale) from 0 to 10 with 0 corresponding to "no pain" and 10 corresponding to "very painful"'}, {'measure': 'Gag reflex during impression taking', 'timeFrame': '15 minutes', 'description': 'VAS (Visual Analogue Scale) from 0 to 10 with 0 corresponding to "no gag reflex" and 10 corresponding to "vomiting"'}, {'measure': 'Respiratory difficulty', 'timeFrame': '15 minutes', 'description': 'VAS (Visual Analogue Scale) from 0 to 10 with 0 corresponding to "no respiratory difficulty" and 10 corresponding to "maximum respiratory difficulty"'}, {'measure': 'Duration of the impression procedure', 'timeFrame': '15 minutes', 'description': 'Time recorded in minutes'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dental Impression Technique']}, 'referencesModule': {'references': [{'pmid': '36891891', 'type': 'DERIVED', 'citation': 'Bosoni C, Nieri M, Franceschi D, Souki BQ, Franchi L, Giuntini V. Comparison between digital and conventional impression techniques in children on preference, time and comfort: A crossover randomized controlled trial. Orthod Craniofac Res. 2023 Nov;26(4):585-590. doi: 10.1111/ocr.12648. Epub 2023 Mar 20.'}]}, 'descriptionModule': {'briefSummary': 'The impression is a necessary step for the orthodontic diagnosis. Digital impression has recently been introduced by means of intraoral optical scanners. To date, few studies have compared the conventional alginate impression with the digital impression with intraoral scanners. These studies have shown that digital impression could have some advantages in terms of satisfaction and less discomfort for the pediatric patient. Only one study is randomized and has analyzed patients between 10 and 17 years of age. There are, therefore, no randomized trials for patients under 10 years of age.\n\nThe objective of the study is to compare the conventional alginate impression with the digital impression of both dental arches in orthodontic patients between 6 and 10 years of age with a randomized crossover design. In particular, the preference, comfort, impression taking time and other subjective aspects will be analyzed. This is a monocentric, controlled, superiority, randomized, crossover, open study.\n\nInclusion criteria:\n\n\\- Orthodontic patients between 6 and 10 years of age.\n\nExclusion criteria:\n\n* Noncompliant patients\n* patients with syndromes or systemic diseases\n* patients suffering from cleft lip and palate. The patient will be asked which of the 2 dental arch impression procedures they prefer. In addition, patients will be provided with a questionnaire including VAS (Visual Analogue Scale) for comfort, pain, gag reflex and breathing difficulty. The VAS will consist of scales from 0 to 10.\n\nAs for the calculation of the sample size, this has been done by considering a null hypothesis for a proportion of 50% in the preference between the two treatments and an alternative hypothesis of 80%. For alpha set at 0.05, a power of 80% and a dropout rate of 10%, 24 patients are required.\n\nDescriptive statistics will be performed for all variables (frequency and percentage for qualitative variables and mean and standard deviation for quantitative variables). For the primary endpoint variable, impression procedure preference, the test will be performed for one proportion and the 95% confidence interval will be calculated using the Clopper-Pearson method.\n\nWith regard to the secondary endpoint variables, duration of the procedure, comfort, pain, gag reflex, breathing difficulty, the 2 procedures will be compared with the t-test for paired data.\n\nAn Intention-To-Treat analysis will be performed. In case more than 5 deviations from the protocol will occur, a sensitivity analysis will also be performed per protocol.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Orthodontic patients between 6 and 10 years of age.\n\nExclusion Criteria:\n\n* Noncompliant patients\n* patients with syndromes or systemic diseases\n* patients suffering from cleft lip and palate.'}, 'identificationModule': {'nctId': 'NCT04220957', 'briefTitle': 'Digital Versus Conventional Impression Techniques in Children', 'organization': {'class': 'OTHER', 'fullName': 'University of Florence'}, 'officialTitle': 'Comparison Between Digital and Conventional Impression Techniques in Children: a Crossover Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'LF8'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Digital Impression Technique', 'description': 'Impression with an intraoral scanner (TRIOS 3, 3Shape, Denmark)', 'interventionNames': ['Other: Digital Impression Technique']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional Impression Technique', 'description': 'Conventional impression with alginate (Orthoprint, Zhermack)', 'interventionNames': ['Other: Conventional Impression Technique']}], 'interventions': [{'name': 'Digital Impression Technique', 'type': 'OTHER', 'description': 'Digital impressions of both arches will be taken by using an intraoral scanner (Trios 3, 3Shape, Denmark) by adhering to the scanning pattern recommended by the company for routine diagnosis and recording.', 'armGroupLabels': ['Digital Impression Technique']}, {'name': 'Conventional Impression Technique', 'type': 'OTHER', 'description': 'Conventional Impression Technique of both arches will be taken with alginate (Orthoprint, Zhermack) on conventional stainless steel impression trays.', 'armGroupLabels': ['Conventional Impression Technique']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50127', 'city': 'Florence', 'country': 'Italy', 'facility': 'SOD Odontostomatologia', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florence', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professsor', 'investigatorFullName': 'Lorenzo Franchi', 'investigatorAffiliation': 'University of Florence'}}}}