Ignite Creation Date:
2025-12-24 @ 9:13 PM
Ignite Modification Date:
2025-12-30 @ 3:13 PM
Study NCT ID:
NCT06635304
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-02-05
First Post:
2024-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Miniscrews Placement for Orthodontic Anchorage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-01-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-01', 'studyFirstSubmitDate': '2024-10-06', 'studyFirstSubmitQcDate': '2024-10-08', 'lastUpdatePostDateStruct': {'date': '2025-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Influence of palatal vault morphology on primary and secondary outcome', 'timeFrame': 'Through study completion, an average of 6 months', 'description': 'For each model, palatal vault morphology (deep/flat) will be assessed according to Korkhaus index.'}], 'primaryOutcomes': [{'measure': 'Inter- and intra-operator variability and accuracy in miniscrews direct placement compared to CBCT-guided planning', 'timeFrame': 'Baseline, up to 1 month', 'description': 'For each model, miniscrew coordinates (as placed by recruited orthodontists) will be recorded. To this purpose, all models will be prepared using Meshmixer software (version 3.5; Autodesk Inc) by positioning the Y-axis reference on the median palatal suture and considering the center of the Cartesian coordinate system at the most distal point of the incisive papilla. Miniscrew position and reference position planned with CBCT will be statistically compared using parametric or non-parametric tests depending on the normality of the data. Miniscrew placement will be repeated on the same models by the same operators within 1 month after.'}], 'secondaryOutcomes': [{'measure': 'Consistency among operators in identifying the third palatal ruga', 'timeFrame': 'Immediatly after the procedure', 'description': 'For each model, recruited orthodontists will identify the most medial and the most lateral points of the third palatal ruga.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Miniscrews', 'Third palatal ruga'], 'conditions': ['Miniscrew Placement', 'Third Palatal Ruga']}, 'referencesModule': {'references': [{'pmid': '11343019', 'type': 'BACKGROUND', 'citation': 'Hoggan BR, Sadowsky C. The use of palatal rugae for the assessment of anteroposterior tooth movements. Am J Orthod Dentofacial Orthop. 2001 May;119(5):482-8. doi: 10.1067/mod.2001.113001.'}, {'pmid': '34344059', 'type': 'BACKGROUND', 'citation': 'Iodice G, Nanda R, Drago S, Repetto L, Tonoli G, Silvestrini-Biavati A, Migliorati M. Accuracy of direct insertion of TADs in the anterior palate with respect to a 3D-assisted digital insertion virtual planning. Orthod Craniofac Res. 2022 May;25(2):192-198. doi: 10.1111/ocr.12525. Epub 2021 Aug 9.'}, {'pmid': '7726462', 'type': 'BACKGROUND', 'citation': 'Almeida MA, Phillips C, Kula K, Tulloch C. Stability of the palatal rugae as landmarks for analysis of dental casts. Angle Orthod. 1995;65(1):43-8. doi: 10.1043/0003-3219(1995)0652.0.CO;2.'}, {'pmid': '32256130', 'type': 'BACKGROUND', 'citation': 'Cantarella D, Savio G, Grigolato L, Zanata P, Berveglieri C, Lo Giudice A, Isola G, Del Fabbro M, Moon W. A New Methodology for the Digital Planning of Micro-Implant-Supported Maxillary Skeletal Expansion. Med Devices (Auckl). 2020 Mar 18;13:93-106. doi: 10.2147/MDER.S247751. eCollection 2020.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this retrospective observational mono-center study is to evaluate inter- and intra-operator variability and accuracy in miniscrews placement compared to CBCT-guided planning. The main questions it aims to answer are:\n\n* Is there inter- and intra-operator variability in miniscrews placement?\n* Is CBCT-guided placement more accurate than direct technique?\n* Is there consistency among operators in identifying the third palatal ruga?\n* Is there an influence of palatal vault morphology on these results?\n\nThe study will be conducted on a sample of 736 cases, that underwent digital planning for palatal mini-implants with the superimposition between the virtual model of the arch and the CBCT or latero-lateral teleradiography. The sample will be provided by a specialist in the field (Professor Giuseppe Perinetti, Adjunct Professor at Vita-Salute San Raffaele University) in anonymized form. From this sample the virtual models, that meet inclusion and exclusion criteria, will be selected and divided in two subgroups according to the palatal vault morphology (deep/flat) using the Korkhaus Index, which relates the distance between the first molars (specifically between the intersection point of the transverse groove and the buccal groove of each first molar) and the height of the palatal vault (i.e., the length of a vertical line perpendicular to the median palatal suture and the previously drawn line) setting the cutoff to determine the depth of the palatal vault at 42%. Below this percentage, the vault is considered flat; above this percentage, it is considered deep.\n\nThe operators involved will be orthodontists with varying levels of experience. At two different times, using Meshmixer software, they will digitally place a miniscrew in the left hemi-palate of each model and identify the most medial and lateral point of third palatal ruga. The placement of the miniscrews will be repeated by the same operators on the same models after a period of time.\n\nBefore proceeding with the placement, they will be instructed on the clinical references for positioning palatal mini-implants and on the use of Meshmixer software. Two trial placements will be proposed to make operators familiarize with the software and the described positioning parameters in the presence of an expert clinician.\n\nThe most adopted references in the literature, which will be therefore illustrated, are as follows:\n\n* Placement at the third palatal ruga or up to 2 mm posteriorly, specifying that some authors discourage positioning directly over the third palatal ruga due to the risk of incorrect mini-implant angulation during insertion\n* A distance from the midline ranging from 3 to 5 mm\n* Regarding the inclination of the mini-implant, it was specified that Wilmes and co-authors recommend inserting it perpendicularly to the occlusal plane, although this parameter was not considered; what truly matters is the point where the mini-implant penetrates the bone.\n\nThe identification of the third ruga and the positioning of the mini-implant will occur at different times and in random order.\n\nData collected will be analyzed through statistical methods.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Data will be collected from patients treated between 2021 and 2024 with an age range of 11 to 55 years with the most represented age group being 12-30 years. The patients underwent only the CBCT-guided digital planning of mini-implant placement performed in compliance with ALADA principle.Therefore, patients may not have subsequently undergone the actual clinical insertion of the miniscrews. The patient data were anonymously collected at Professor Giuseppe Perinetti's private clinic.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Completeness of data and records\n* Good quality of available records, particularly models and CBCT\n* Healthy patients\n* Digital planning performed using CBCT\n* Placement of orthodontic mini-implants in the anterior paramedian area of the palate\n\nExclusion Criteria:\n\n* Craniofacial anomalies and congenital syndromes (such as cleft lip and palate)\n* Cysts and tumors of the jaws\n* Presence of impacted teeth\n* Presence of several palatal ectopias of the teeth'}, 'identificationModule': {'nctId': 'NCT06635304', 'briefTitle': 'Miniscrews Placement for Orthodontic Anchorage', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS San Raffaele'}, 'officialTitle': 'A Retrospective Observational Mono-center Study Of Miniscrews Placement For Orthodontic Anchorage', 'orgStudyIdInfo': {'id': 'TADs'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Deep vault', 'description': 'All digital models with deep palatal vault will be included in this group. The depth of the vaults will be assessed according to the Korkhaus index, which sets the cutoff for determining the depth of the palatal vault at 42%. Below this percentage, the vault is considered deep; above this percentage, it is considered flat.'}, {'label': 'Flat vault', 'description': 'All digital models with flat palatal vault will be included in this group. The depth of the vaults will be assessed according to the Korkhaus index, which sets the cutoff for determining the depth of the palatal vault at 42%. Below this percentage, the vault is considered deep; above this percentage, it is considered flat.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20132', 'city': 'Milan', 'state': 'Italy', 'country': 'Italy', 'facility': 'Dental Clinic, IRCCS San Raffaele Hospital', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'overallOfficials': [{'name': 'Enrico Gherlone', 'role': 'STUDY_CHAIR', 'affiliation': 'IRCCS San Raffaele Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS San Raffaele', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Simona Tecco', 'investigatorAffiliation': 'IRCCS San Raffaele'}}}}