Posterior Crossbite6vsENCT02798822
Maxillary and Mandibular Arch Response to RME: a Multicentric Randomized Controlled Trial
A study testing Rapid maxillary expansion in people with Posterior Crossbite, run by University of Genova at 3 sites in Italy.
Trial summary
Posterior crossbite is a common clinical condition often associated with transverse maxillary deficiency and functional mandibular shift. This frequent malocclusion is not self-correcting and can lead to the development of craniofacial asymmetries and mandibular dysfunction. Read more about this study
- Who is it for?
- Ages 8 to 10 years
- Conditions the study is for
- Posterior Crossbite
- What is being tested?
- Rapid maxillary expansion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 3 sitesItaly
- Study dates
- Jun 2013to Apr 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 8 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients in mixed dentition
- Unilateral posterior crossbite at least of the first permanent molar
- Upper deciduous second molars available as RME anchoring teeth
Who cannot join
- Primary exclusion criteria
- Previous orthodontic treatment
- Hypodontia in any quadrant excluding third molars
- Inadequate oral hygiene
- Temporomandibular joint disorders
- Craniofacial abnormalities
Show all 11Show fewer
- Secondary exclusion criteria
- Lack of records
- Need for lingual arch
- Lack of consensus
- Need for other orthodontic treatment during rapid maxillary expansion
Trial locations and contacts
3 sites in 1 country.
Italy3 sites
Ortohdontic Department - Univesity of Genoa
Genova, 16100
Ortohdontic Department - Univesity of Siena
Siena
Orthodontic Department - University of Varese
Varese
About this study
Official title: Dental Arches Response to Haas-type RME Anchored to Deciduous vs Permanent Molars in Children With Unilateral Posterior Crossbite
Posterior crossbite is a common clinical condition often associated with transverse maxillary deficiency and functional mandibular shift. This frequent malocclusion is not self-correcting and can lead to the development of craniofacial asymmetries and mandibular dysfunction.
The aim of the current study was to evaluate maxillary and mandibular arch widths' response to RME when it is anchored to the upper second deciduous molars or to the upper first permanent molars and to create a decision-making protocol for RME therapy in mixed-dentition patients.
Read the detailed description
The effects of rapid maxillary expansion (RME) on the maxillary complex have been highly investigated,4 reporting a maximum maxillary intermolar and intercanine width increase of 6.7 mm and 5.3 mm,5 respectively, when RME is banded on upper first permanent molars.
Literature also reported cases of periodontal and endodontic damage on RME anchoring teeth; therefore, some authors have suggested banding RME on primary teeth and reporting also different mean intermolar (3.6-4.1 mm) and intercanine width increases (5-5.9 mm).
Few studies have investigated the changes in molar dental tipping and inclinations (on average from 3° up to 16.7°) following RME but comprised difficult (ie, barium sulfate solution) and more invasive examinations such as computed tomography and cone beam computed tomography (CBCT) Few articles concerning the indirect effects on mandibular arch following RME reported a low but statistically significant increase of lower intermolar (0.66-0.97 mm) and intercanine width (0.9 mm). Since no studies in the literature have analyzed the differences in permanent vs primary molars as anchoring teeth for RME, the decision to band the permanent deciduous molars did not follow a clinical protocol, but an individual decision was made for each patient based on clinician experience.
- Conditions
- Posterior Crossbite
- Being tested
- Rapid maxillary expansion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapid maxillary expansionProcedure or surgery
When rapid maxillary expander was in-situ, patients waited 7 days before starting the screw activation of one quarter turn a day (0.22 mm) until overcorrection. Expansion was considered adequate when the occlusal surface of the first maxillary palatal cusp contacted the occlusal surface of the mandibular first molar facial cusp. When was achieved, rapid maxillary expander stayed in place for 10 months.
| Study group | Role | What they receive |
|---|---|---|
| RME on upper first permanent molars | Active comparator | Intervention/Procedure: Rapid maxillary expansion. When RME was in situ, patients started the screw activation (Snap-lock expander screw, Forestadent, Pforzheim, Germany) of one-quarter turn a day (0.22 mm) until overcorrection was achieved (ie, the occlusal surface of the first maxillary palatal cusp contacted the occlusal surface of the mandibular first molar facial cusp), and the RME remained in place for 10 months. The screw was turned for 35 ± 6 days for Gr6, and the average treatment time was 12 ± 1.3 months. Receives: Procedure: Rapid maxillary expansion |
| RME on upper second deciduous molars | Active comparator | Intervention/Procedure: Rapid maxillary expansion. When RME was in situ, patients started the screw activation (Snap-lock expander screw, Forestadent, Pforzheim, Germany) of one-quarter turn a day (0.22 mm) until overcorrection was achieved (ie, the occlusal surface of the first maxillary palatal cusp contacted the occlusal surface of the mandibular first molar facial cusp), and the RME remained in place for 10 months. The screw was turned for 41 ± 8 days, and the average treatment time was 12 ± 1.3 months. Receives: Procedure: Rapid maxillary expansion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Crossbite correction (binary outcome yes/no: clinical evaluation in vivo and on digital dental casts)
Measured: 5 months
Secondary outcomes (10)
Crossbite correction stability (binary outcome yes/no: clinical evaluation in vivo and measured on digital dental casts)
Measured: 10 months
Canine angulation (degrees of transverse expansion measured on digital dental casts)
Measured: 5 months
Canine angulation (degrees of transverse expansion measured on digital dental casts)
Measured: 10 months
Molar angulation (degrees of transverse expansion measured on digital dental casts)
Measured: 5 months
Molar angulation (degrees of transverse expansion measured on digital dental casts)
Measured: 10 months
Molar expansion (mm of transverse expansion measured on digital dental casts)
Measured: 5 months
Molar expansion (mm of transverse expansion measured on digital dental casts)
Measured: 10 months
Canine Expansion (mm of transverse expansion measured on digital dental casts)
Measured: 5 months
Canine Expansion (mm of transverse expansion measured on digital dental casts)
Measured: 10 months
Upper and lower incisor angulation and rotation (changes in mm and degrees of dental angulation and rotation measured on digital dental casts and Dental digital X-ray)
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2016 (estimated)
- Study startJun 2013
- Primary completionFeb 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Posterior CrossbiteStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Genova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ALESSANDRO UGOLINI, University of Genova
- Investigators
- Alessandro Ugolini, DDS, PhD, Principal investigator, University of Genova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02798822
- Sponsor's protocol ID
- 80911110
- Acronym
- 6vsE
- Status last verified
- Jun 2016
- First submitted
- 2 Aug 2013
- Last updated
- 14 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Cerruto C, Ugolini A, Di Vece L, Doldo T, Caprioglio A, Silvestrini-Biavati A. Cephalometric and dental arch changes to Haas-type rapid maxillary expander anchored to deciduous vs permanent molars: a multicenter, randomized controlled trial. J Orofac Orthop. 2017 Sep;78(5):385-393. doi: 10.1007/s00056-017-0092-2. Epub 2017 Apr 10.
PubMed 28397083
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dental Arches Response to Haas-type RME Anchored to Deciduous vs Permanent Molars in Children With Unilateral Posterior Crossbite
- ClinicalTrials.gov ID
- NCT02798822
- Acronym / sponsor ID
- 6vsE / 80911110
- Conditions
- Posterior Crossbite
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- University of GenovaUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 14 Jun 2016 (estimated)
- 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.
Posterior crossbite is a common clinical condition often associated with transverse maxillary deficiency and functional mandibular shift. This frequent malocclusion is not self-correcting and can lead to the development of craniofacial asymmetries and mandibular dysfunction.
The aim of the current study was to evaluate maxillary and mandibular arch widths' response to RME when it is anchored to the upper second deciduous molars or to the upper first permanent molars and to create a decision-making protocol for RME therapy in mixed-dentition patients.
Detailed description
The effects of rapid maxillary expansion (RME) on the maxillary complex have been highly investigated,4 reporting a maximum maxillary intermolar and intercanine width increase of 6.7 mm and 5.3 mm,5 respectively, when RME is banded on upper first permanent molars.
Literature also reported cases of periodontal and endodontic damage on RME anchoring teeth; therefore, some authors have suggested banding RME on primary teeth and reporting also different mean intermolar (3.6-4.1 mm) and intercanine width increases (5-5.9 mm).
Few studies have investigated the changes in molar dental tipping and inclinations (on average from 3° up to 16.7°) following RME but comprised difficult (ie, barium sulfate solution) and more invasive examinations such as computed tomography and cone beam computed tomography (CBCT) Few articles concerning the indirect effects on mandibular arch following RME reported a low but statistically significant increase of lower intermolar (0.66-0.97 mm) and intercanine width (0.9 mm). Since no studies in the literature have analyzed the differences in permanent vs primary molars as anchoring teeth for RME, the decision to band the permanent deciduous molars did not follow a clinical protocol, but an individual decision was made for each patient based on clinician experience.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RME on upper first permanent molars | Active comparator | Procedure: Rapid maxillary expansionIntervention/Procedure: Rapid maxillary expansion. When RME was in situ, patients started the screw activation (Snap-lock expander screw, Forestadent, Pforzheim, Germany) of one-quarter turn a day (0.22 mm) until overcorrection was achieved (ie, the occlusal surface of the first maxillary palatal cusp contacted the occlusal surface of the mandibular first molar facial cusp), and the RME remained in place for 10 months. The screw was turned for 35 ± 6 days for Gr6, and the average treatment time was 12 ± 1.3 months. |
| RME on upper second deciduous molars | Active comparator | Procedure: Rapid maxillary expansionIntervention/Procedure: Rapid maxillary expansion. When RME was in situ, patients started the screw activation (Snap-lock expander screw, Forestadent, Pforzheim, Germany) of one-quarter turn a day (0.22 mm) until overcorrection was achieved (ie, the occlusal surface of the first maxillary palatal cusp contacted the occlusal surface of the mandibular first molar facial cusp), and the RME remained in place for 10 months. The screw was turned for 41 ± 8 days, and the average treatment time was 12 ± 1.3 months. |
Who may qualify
- Ages
- 8 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Patients in mixed dentition
- Unilateral posterior crossbite at least of the first permanent molar
- Upper deciduous second molars available as RME anchoring teeth
Key exclusion criteria (11 listed)
- Primary exclusion criteria
- Previous orthodontic treatment
- Hypodontia in any quadrant excluding third molars
- Inadequate oral hygiene
- Temporomandibular joint disorders
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 maxillary expansionWhen rapid maxillary expander was in-situ, patients waited 7 days before starting the screw activation of one quarter turn a day (0.22 mm) until overcorrection. Expansion was considered adequate when the occlusal surface of the first maxillary palatal cusp contacted the occlusal surface of the mandibular first molar facial cusp. When was achieved, rapid maxillary expander stayed in place for 10 months. | Procedure or surgery | RME on upper first permanent molars, RME on upper second deciduous molars |
Primary outcome
Crossbite correction (binary outcome yes/no: clinical evaluation in vivo and on digital dental casts)
Time frame: 5 months
10 secondary outcomes
Crossbite correction stability (binary outcome yes/no: clinical evaluation in vivo and measured on digital dental casts)
Time frame: 10 months
Canine angulation (degrees of transverse expansion measured on digital dental casts)
Time frame: 5 months
Canine angulation (degrees of transverse expansion measured on digital dental casts)
Time frame: 10 months
Molar angulation (degrees of transverse expansion measured on digital dental casts)
Time frame: 5 months
Molar angulation (degrees of transverse expansion measured on digital dental casts)
Time frame: 10 months
Molar expansion (mm of transverse expansion measured on digital dental casts)
Time frame: 5 months
Molar expansion (mm of transverse expansion measured on digital dental casts)
Time frame: 10 months
Canine Expansion (mm of transverse expansion measured on digital dental casts)
Time frame: 5 months
Canine Expansion (mm of transverse expansion measured on digital dental casts)
Time frame: 10 months
Upper and lower incisor angulation and rotation (changes in mm and degrees of dental angulation and rotation measured on digital dental casts and Dental digital X-ray)
Time frame: 10 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2016.
- Derived from this study: PubMed 28397083Cerruto C, Ugolini A, Di Vece L, Doldo T, Caprioglio A, Silvestrini-Biavati A. Cephalometric and dental arch changes to Haas-type rapid maxillary expander anchored to deciduous vs permanent molars: a multicenter, randomized controlled trial. J Orofac Orthop. 2017 Sep;78(5):385-393. doi: 10.1007/s00056-017-0092-2. Epub 2017 Apr 10.
- Individual participant dataSharing planned: Undecided
Related trials for Posterior Crossbite
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Evaluation of Occlusal Force Following Rapid Maxillary Expansion Assisted by Piezocision in Different Age Groups
Maxillary Transverse Deficiency, Rapid Maxillary Expansion
Recruiting
Posterior Resin Bite Turbos Effect on Maxillary Expansion Using a HYRAX Expander in Early Adolescents
Maxillary Transverse Deficiency (Posterior Crossbite) in Early Adolescent Patients
Recruiting
Leaf Expander Versus Hyrax Expander in Mixed Dentition Patients With Posterior Crossbite.
Posterior Crossbite, Maxilla; Hypoplasia
Not yet recruitingObservational study
Correlation Between Posterior Crossbite and Risk of Obstructive Sleep Apnea
Crossbite Teeth
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.
Alessandro Ugolini, DDS, PhD principal investigator
University of Genova
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rapid maxillary expansion in people with Posterior Crossbite, run by University of Genova at 3 sites 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 11 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: finished, as of the sponsor's last update on 14 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Crossbite correction (binary outcome yes/no: clinical evaluation in vivo and on digital dental casts) (time frame: 5 months). 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 NCT02798822, which also lists 1 linked publication.
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 14 Jun 2016.