Maxillary DeficiencyNCT07095374
Associations Between Radiographic Inclination of Premolars and Maxillary Expansion
An observational study of Maxillary Deficiency, run by University of Pavia at 1 site in Italy.
Trial summary
Recruitment of patients treated using rapid maxillary expanders with dental anchorage, with pre-treatment panoramic X-rays and post-treatment models. In the initial phase of the study, the objective is to correlate the radiographic inclination of the upper permanent premolars in the pre-treatment orthopantomography to… Read more about this study
- Who is it for?
- Ages 6 to 14 years
- Conditions the study is for
- Maxillary Deficiency
- What is being tested?
- Rapid palatal expansion
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2025to Jul 2026
- 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 6 to 14 years
- All sexes
- No healthy volunteers
- Child
Study population: Patients referring to the Unit of Orthodontics and Pediatric Dentistry for oral care
Who may be able to join
- Patients scheduled for orthopedic treatment with rapid palatal expander
- Pre-treatment orthopantomography
- Pre and post treatment intraoral scan
Who cannot join
- Previous maxillofacial surgery
- cleft lip and palate
- premolar agenesis or extraction for fracture ecc.
- Previous orthopedic-orthodontic treatments
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia
Pavia, Lombardy, 27100
About this study
Official title: Associations Between Radiographic Inclination of Premolars and Maxillary Expansion: Retrospective Observational Study
Recruitment of patients treated using rapid maxillary expanders with dental anchorage, with pre-treatment panoramic X-rays and post-treatment models. In the initial phase of the study, the objective is to correlate the radiographic inclination of the upper permanent premolars in the pre-treatment orthopantomography to the expansion obtained at the end of therapy using a palatal expander with dental anchorage.
Read the detailed description
Maxillary transverse deficiency is a common malocclusion, frequently associated with unilateral or bilateral posterior crossbite, with a prevalence ranging from 8% to 22%. Since transverse development occurs earlier than vertical and sagittal development, inadequate transverse growth can also affect overall craniofacial development. This deficiency can impact aesthetics and functions such as creating excessive buccal corridor spaces, causing dental crowding, and reducing nasal cavity volume, which can lead to breathing difficulties. Thus, timely correction of maxillary transverse deficiency is crucial for harmonizing the relationship between the upper and lower jaws, as well as for enhancing aesthetics and functionality. Currently, rapid maxillary expansion (RME) is a widely accepted and established treatment for correcting maxillary constriction in patients during their peak growth period.
There is no protocol in the literature that investigates the need for transverse expansion of the upper jaw through the analysis of the inclination of the long axis of the upper premolars and canines. Therefore, the aim of this study is to investigate the predictability of the necessary expansion through the analysis of the inclination of the upper premolars and canines in orthopantomography.
In this retrospective study, patients who are scheduled for treatment using rapid palatal expanders with dental anchorage will be recruited. A requirement for recruitment will be the presence of pre-treatment orthopantomography.
The inclination of the tooth will be calculated between the long axis of the tooth and the middle line as previously described by Baccetti et all. In their works regarding impacted canines.
The achieved expansion will be evaluated based on the number of activations recorded in each individual patient's chart clinical records.
- Conditions
- Maxillary Deficiency
- Being tested
- Rapid palatal expansion
- Medical subject headings
- Retrognathia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapid palatal expansionOther
Patients undergone orthopedic treatment with rapid palatal expander
| Study group | Role | What they receive |
|---|---|---|
| Orthodontic patients undergone rapid palatal expander treatment | Patients treated with rapid palatal expansion. Patients must have a pre-treatment and post-treatment orthopantomography. Receives: Other: Rapid palatal expansion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of required activation for maxillary expansion
Correlation between the number of activations of the rapid palatal expander and premolar inclination (angle between the long axis of the premolars with the occlusal plane)
Measured: T0 (pre-treatment casts/x-rays) and T1 (post-treatment casts/x-rays)
Secondary outcomes (1)
Canine inclination
Angle between canines and the occlusal plane
Measured: T0 (pre-treatment x-rays) and T1 (post-treatment x-rays)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start1 Sep 2025
- Primary completionJun 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maxillary DeficiencyStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Scribante, University of Pavia
- Investigators
- Andrea Scribante, DDS, phD, Principal investigator, University of Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07095374
- Sponsor's protocol ID
- 2025-PREMOLARSEXPANSION
- Status last verified
- Nov 2025
- First submitted
- 26 Jun 2025
- Last updated
- 18 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be available upon motivated request to the principal investigator.
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Associations Between Radiographic Inclination of Premolars and Maxillary Expansion: Retrospective Observational Study
- ClinicalTrials.gov ID
- NCT07095374
- Acronym / sponsor ID
- 2025-PREMOLARSEXPANSION
- Conditions
- Maxillary Deficiency
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 31 Jul 2025 (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.
Recruitment of patients treated using rapid maxillary expanders with dental anchorage, with pre-treatment panoramic X-rays and post-treatment models. In the initial phase of the study, the objective is to correlate the radiographic inclination of the upper permanent premolars in the pre-treatment orthopantomography to the expansion obtained at the end of therapy using a palatal expander with dental anchorage.
Detailed description
Maxillary transverse deficiency is a common malocclusion, frequently associated with unilateral or bilateral posterior crossbite, with a prevalence ranging from 8% to 22%. Since transverse development occurs earlier than vertical and sagittal development, inadequate transverse growth can also affect overall craniofacial development. This deficiency can impact aesthetics and functions such as creating excessive buccal corridor spaces, causing dental crowding, and reducing nasal cavity volume, which can lead to breathing difficulties. Thus, timely correction of maxillary transverse deficiency is crucial for harmonizing the relationship between the upper and lower jaws, as well as for enhancing aesthetics and functionality. Currently, rapid maxillary expansion (RME) is a widely accepted and established treatment for correcting maxillary constriction in patients during their peak growth period.
There is no protocol in the literature that investigates the need for transverse expansion of the upper jaw through the analysis of the inclination of the long axis of the upper premolars and canines. Therefore, the aim of this study is to investigate the predictability of the necessary expansion through the analysis of the inclination of the upper premolars and canines in orthopantomography.
In this retrospective study, patients who are scheduled for treatment using rapid palatal expanders with dental anchorage will be recruited. A requirement for recruitment will be the presence of pre-treatment orthopantomography.
The inclination of the tooth will be calculated between the long axis of the tooth and the middle line as previously described by Baccetti et all. In their works regarding impacted canines.
The achieved expansion will be evaluated based on the number of activations recorded in each individual patient's chart clinical records.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Orthodontic patients undergone rapid palatal expander treatment | – | Other: Rapid palatal expansionPatients treated with rapid palatal expansion. Patients must have a pre-treatment and post-treatment orthopantomography. |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients referring to the Unit of Orthodontics and Pediatric Dentistry for oral care
Key inclusion criteria (3 listed)
- Patients scheduled for orthopedic treatment with rapid palatal expander
- Pre-treatment orthopantomography
- Pre and post treatment intraoral scan
Key exclusion criteria (4 listed)
- Previous maxillofacial surgery
- cleft lip and palate
- premolar agenesis or extraction for fracture ecc.
- Previous orthopedic-orthodontic treatments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rapid palatal expansionPatients undergone orthopedic treatment with rapid palatal expander | Other | Orthodontic patients undergone rapid palatal expander treatment |
Primary outcome
Number of required activation for maxillary expansion
Time frame: T0 (pre-treatment casts/x-rays) and T1 (post-treatment casts/x-rays)
Correlation between the number of activations of the rapid palatal expander and premolar inclination (angle between the long axis of the premolars with the occlusal plane)
1 secondary outcome
Canine inclination
Time frame: T0 (pre-treatment x-rays) and T1 (post-treatment x-rays)
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 18 Nov 2025.
- Individual participant dataSharing planned: No. Data will be available upon motivated request to the principal investigator.
Related trials for Maxillary Deficiency
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Alveolar Bone Deficiency
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Three-Dimensional Facial Soft Tissue Changes and Clinical Perception Following MARPE
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Tooth-Borne (TBA) Versus Hybrid Expanders (HA) in Surgically Assisted Rapid Maxillary Expansion (SARME)
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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.
Andrea Scribante, DDS, phD principal investigator
University of Pavia
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 Maxillary Deficiency, run by University of Pavia 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 3 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: enrolling by invitation, as of the sponsor's last update on 18 Nov 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?
Number of required activation for maxillary expansion (time frame: T0 (pre-treatment casts/x-rays) and T1 (post-treatment casts/x-rays)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Nov 2025.