Miniscrew PlacementNCT06635304
Miniscrews Placement for Orthodontic Anchorage
An observational study of Miniscrew Placement and Third Palatal Ruga, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Miniscrew Placement, Third Palatal Ruga
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 7 Jan 2025to Jun 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- Completeness of data and records
- 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
Who cannot join
- Craniofacial anomalies and congenital syndromes (such as cleft lip and palate)
- Cysts and tumors of the jaws
- Presence of impacted teeth
- Presence of several palatal ectopias of the teeth
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Retrospective Observational Mono-center Study Of Miniscrews Placement For Orthodontic Anchorage
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:
- 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?
Read more
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.
- Conditions
- Miniscrew Placement, Third Palatal Ruga
- Keywords
- Miniscrews, Third palatal ruga
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inter- and intra-operator variability and accuracy in miniscrews direct placement compared to CBCT-guided planning
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.
Measured: Baseline, up to 1 month
Secondary outcomes (1)
Consistency among operators in identifying the third palatal ruga
For each model, recruited orthodontists will identify the most medial and the most lateral points of the third palatal ruga.
Measured: Immediatly after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start7 Jan 2025
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Miniscrew PlacementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simona Tecco, IRCCS San Raffaele
- Investigators
- Enrico Gherlone, Study chair, IRCCS San Raffaele Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06635304
- Sponsor's protocol ID
- TADs
- Status last verified
- Oct 2024
- First submitted
- 6 Oct 2024
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 11343019Iodice 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.
PubMed 34344059Almeida 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.
PubMed 7726462Cantarella 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.
PubMed 32256130
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Observational Mono-center Study Of Miniscrews Placement For Orthodontic Anchorage
- ClinicalTrials.gov ID
- NCT06635304
- Acronym / sponsor ID
- TADs
- Conditions
- Miniscrew Placement, Third Palatal Ruga
- Keywords
- Miniscrews, Third palatal ruga
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 7 Jan 2025 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 10 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- Completeness of data and records
- 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
Key exclusion criteria (4 listed)
- Craniofacial anomalies and congenital syndromes (such as cleft lip and palate)
- Cysts and tumors of the jaws
- Presence of impacted teeth
- Presence of several palatal ectopias of the teeth
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Inter- and intra-operator variability and accuracy in miniscrews direct placement compared to CBCT-guided planning
Time frame: Baseline, up to 1 month
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.
1 secondary outcome
Consistency among operators in identifying the third palatal ruga
Time frame: Immediatly after the procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
- Background: PubMed 11343019Hoggan 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.
- Background: PubMed 34344059Iodice 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.
- Background: PubMed 7726462Almeida 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.
- Background: PubMed 32256130Cantarella 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Enrico Gherlone study chair
IRCCS San Raffaele Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Miniscrew Placement and Third Palatal Ruga, run by IRCCS San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inter- and intra-operator variability and accuracy in miniscrews direct placement compared to CBCT-guided planning (time frame: Baseline, up to 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06635304, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2025.