Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:12 AM
Study NCT ID:
NCT04419805
Status:
RECRUITING
Last Update Posted:
2024-02-12
First Post:
2020-05-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Single Palatal Temporary Anchorage Device for Anterior Open Bite
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Outcome assessor will be blind to allocation'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomised parallel 2 group clinical trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 32}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-08', 'studyFirstSubmitDate': '2020-05-29', 'studyFirstSubmitQcDate': '2020-06-04', 'lastUpdatePostDateStruct': {'date': '2024-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Molar intrusion', 'timeFrame': '9-12 months after treatment commences', 'description': 'Amount of upper molar intrusion measured in mms on cephalometric radiograph'}], 'secondaryOutcomes': [{'measure': 'Overbite (vertical overlap of anterior teeth)', 'timeFrame': '9-12 months after treatment commences', 'description': 'Change in overbite (vertical overlap of anterior teeth) measured clinically directly from the teeth with a ruler and on 3D dental scans using 3D analysis software, both in mms'}, {'measure': 'Patient Experience', 'timeFrame': '9-12 months after treatment commences', 'description': "Patient experience with the use of temporary anchorage devices for intrusion by validated questionnaire which uses 3 or 4 point Likert Scales for a range of questions across relevant doamins. Depending on the question the scales are 'Improved/Same/Worse/Much worse' or 'Not at all / A little / A lot' or 'I do more / no difference / I do less' (Yassir et al 2017)"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Orthodontics', 'Temporary Anchorage Device', 'Anterior Open Bite'], 'conditions': ['Anterior Openbite']}, 'referencesModule': {'references': [{'pmid': '27864320', 'type': 'BACKGROUND', 'citation': 'Yassir YA, McIntyre GT, Bearn DR. Three questionnaires to assess the perception of fixed orthodontic therapy before, during and after treatment: validity and reliability. Eur J Orthod. 2017 Aug 1;39(4):402-410. doi: 10.1093/ejo/cjw076.'}]}, 'descriptionModule': {'briefSummary': 'Participants are orthodontic patients with anterior open bite (AOB) malocclusion. These patients will be treated by molar intrusion achieved using one of two interventions, either orthodontic fixed appliances incorporating a single palatal Temporary Anchorage Device (TAD) or orthodontic fixed appliances incorporating two buccal TADs', 'detailedDescription': 'Participants will be recruited from those attending Dundee Dental Hospital Orthodontic Department and those currently awaiting treatment. Those that meet the inclusion and exclusion criteria will be invited to participate. After obtaining consent they will be allocated to receive one of the two interventions. The two interventions represent the currently available options for treatment of mild - moderate (1-6mm) anterior open bite in the Orthodontic Department and as such patients will be receiving routine treatment regardless of the arm they are randomised to. In order to assess the more effective intervention additional records will be taken during the treatment involving additional cephalometric radiographs, additional intra-oral scans or dental impressions (See later for details). Primary outcome is at the end of intrusion with TADs after 9-12 months, but participants will be followed until completion of treatment for the secondary outcome of stability of intrusion and overbite correction'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with AOB of 1-6mm\n* Aged between (12 and 40 years).\n* Able to consent.\n* Patient due to undergo orthodontic treatment with fixed orthodontic braces.\n\nExclusion Criteria:\n\n* Patient has previously had upper first permanent molar extraction.\n* Patient with congenital cleft of lip and/or palate or any other craniofacial anomalies.\n* Patient with bone disease or taking medications that affect the bone quality or nature.\n* Patient with an active digit sucking habit.\n* Pregnant or breastfeeding women'}, 'identificationModule': {'nctId': 'NCT04419805', 'acronym': 'SPaTAR', 'briefTitle': 'Single Palatal Temporary Anchorage Device for Anterior Open Bite', 'organization': {'class': 'OTHER', 'fullName': 'University of Dundee'}, 'officialTitle': 'Single Palatal Temporary Anchorage Device for Anterior Open Bite: a Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '2-054-19'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single Palatal TAD', 'description': 'Single Palatal TAD for orthodontic molar intrusion', 'interventionNames': ['Device: Single Palatal TAD']}, {'type': 'EXPERIMENTAL', 'label': 'Two buccal TADs', 'description': 'Two buccal TADs for orthodontic molar intrusion', 'interventionNames': ['Device: Two buccal TADs']}], 'interventions': [{'name': 'Single Palatal TAD', 'type': 'DEVICE', 'description': 'A single mini-screw inserted in the mid-palate', 'armGroupLabels': ['Single Palatal TAD']}, {'name': 'Two buccal TADs', 'type': 'DEVICE', 'description': 'Two buccal TADs inserted in the upper jaw', 'armGroupLabels': ['Two buccal TADs']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DD1 4HR', 'city': 'Dundee', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'David R Bearn, BDS', 'role': 'CONTACT', 'email': 'd.bearn@dundee.ac.uk', 'phone': '01382381604'}, {'name': 'Omar Alshaibi, BDS', 'role': 'CONTACT', 'email': 'o.alshaibi@dundee.ac.uk', 'phone': '07762379239'}], 'facility': 'Dundee Dental Hospital', 'geoPoint': {'lat': 56.46913, 'lon': -2.97489}}], 'centralContacts': [{'name': 'David Bearn, BDS', 'role': 'CONTACT', 'email': 'd.bearn@dundee.ac.uk', 'phone': '01382385024'}, {'name': 'Vera Nuritova, PhD', 'role': 'CONTACT', 'email': 'TASCgovernance@dundee.ac.uk', 'phone': '01382383877'}], 'overallOfficials': [{'name': 'Peter Mossey, BDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Dundee'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Dundee', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Peter Mossey', 'investigatorAffiliation': 'University of Dundee'}}}}