Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
40 participants
OBSERVATIONAL
2025-01-07
2025-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* Is there inter- and intra-operator variability in miniscrews placement?
* Is CBCT-guided placement more accurate than direct technique?
* Is there consistency among operators in identifying the third palatal ruga?
* Is there an influence of palatal vault morphology on these results?
The 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.
The 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.
Before 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.
The most adopted references in the literature, which will be therefore illustrated, are as follows:
* 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
* A distance from the midline ranging from 3 to 5 mm
* 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.
The identification of the third ruga and the positioning of the mini-implant will occur at different times and in random order.
Data collected will be analyzed through statistical methods.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Miniscrews Primary Stability
NCT03696511
Root Proximity During Mini-Screw Insertion Using a Digital Three-Dimensional Printed Guide
NCT03653078
Efficacy of Skeletal Anchorage (MINISCREW)
NCT01025141
The Mini-Screw as Orthodontic Anchoring: Survival, Clinical Efficiency and Experience of the Patient
NCT00137137
Evaluation Of Anchorage Control During Canine Retraction Using Arch Wire Stopper Versus Mini-Screws
NCT06416904
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
RETROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Deep vault
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.
No interventions assigned to this group
Flat vault
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.
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Good quality of available records, particularly models and CBCT
* Healthy patients
* Digital planning performed using CBCT
* Placement of orthodontic mini-implants in the anterior paramedian area of the palate
Exclusion Criteria
* Cysts and tumors of the jaws
* Presence of impacted teeth
* Presence of several palatal ectopias of the teeth
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
IRCCS San Raffaele
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Simona Tecco
Associate Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Enrico Gherlone
Role: STUDY_CHAIR
IRCCS San Raffaele Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Dental Clinic, IRCCS San Raffaele Hospital
Milan, Italy, Italy
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TADs
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.