Posterior CrossbiteNCT04828213
Tooth-Borne Versus Tooth-Bone-Borne Rapid Maxillary Expanders: A Stereophotogrammetric Evaluation of Soft Tissues
A study testing Rapid Maxillary Expansion Treatment with Tooth-borne RME appliance (Hyrax) and Rapid Maxillary Expansion Treatment with Hybrid hyrax RME appliance in people with Posterior Crossbite, run by Gökçenur Gökçe.
Trial summary
The force exerted by the rapid maxillary expansion (RME) appliances provides expansion of the transverse dimension by splitting of the midpalatal suture. This expansion results in three-dimensional (3D) changes in maxillary position which also effects circummaxillary surrounding structures. Read more about this study
- Who is it for?
- Ages 12 to 14 years
- Conditions the study is for
- Posterior Crossbite
- What is being tested?
- Rapid Maxillary Expansion Treatment with Tooth-borne RME appliance (Hyrax) and Rapid Maxillary Expansion Treatment with Hybrid hyrax RME appliance
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 20 May 2016to 17 Jul 2017
- 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 12 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- No previous tonsillar, nasal or adenoid surgery and orthodontic treatment,
- Bilateral crossbite and need for RME,
- Maxillary and mandibular permanent teeth fully erupted,
- Willingness to participate in the study
Who cannot join
- the presence of adenotonsillectomy due to tonsillar hypertrophy or adenoidal hypertrophy
- Having nasal/nasopharyngeal /oropharyngeal pathologies, craniofacial syndromes, systemic disease, poor oral hygiene,
- History of previous orthodontic treatment.
About this study
The force exerted by the rapid maxillary expansion (RME) appliances provides expansion of the transverse dimension by splitting of the midpalatal suture. This expansion results in three-dimensional (3D) changes in maxillary position which also effects circummaxillary surrounding structures. The aim of this randomized clinical trial (RCT) was to evaluate the effects of tooth-borne and tooth-bone-borne rapid maxillary expansion (RME) on soft tissue with stereophotogrammetry.
Read the detailed description
Introduction: To evaluate the effects of tooth-borne and tooth-bone-borne rapid maxillary expansion (RME) on soft tissue with stereophotogrammetry. Methods: 32 patients (15 males, 17 females) who met inclusion criteria were divided into two groups. In the first group, tooth-borne RME appliance (Hyrax) was applied to 16 patients (9 males, 7 females mean age 13.4 ± 1.3 years) and in the second group, tooth-bone-borne RME appliance (Hybrid Hyrax) was applied to 16 patients (6 males, 10 females mean age 13.05 ±1.24 years). A simple electronically generated randomization was performed before trial commencement using the Random Allocation Software program. Allocation concealment involved numbered, sealed, and opaque envelopes prepared before trial commencement. One envelope was sequentially opened for each participant during recruitment. Each envelope contained a card with the name of 1 expander. The initials of the name of the participant, the type of expander, and the date of allocation were identified in the external surface of the envelope. One operator was responsible for the randomization process, allocation concealment, and implementation. The primary outcomes of this study was assessment of changes in soft tissues before RME (T0) and post-retention (T1) period by stereophotogrammetry. Independent and dependent sample t tests were used to compare intra- and inter-group differences at P<0.05 significance level.
- Conditions
- Posterior Crossbite
- Being tested
- Rapid Maxillary Expansion Treatment with Tooth-borne RME appliance (Hyrax), Rapid Maxillary Expansion Treatment with Hybrid hyrax RME appliance
- Keywords
- stereophotogrammetry, Tooth-bone-borne rapid maxillary expansion, skeletal anchorage, mini-screws
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapid Maxillary Expansion Treatment with Tooth-borne RME appliance (Hyrax)Device
The patients were treated with a expansion appliance containing a Hyrax expansion screw positioned parallel to the second premolars and were used to correct the posterior crossbite. RME activation was performed twice a day for the first week and then once per day. When it was decided that the expansion was sufficient (until the palatal tubercles of the upper molars came into contact with the buccal tubercles of the lower molars), the screw was fixed with the 0.012-inch ligature wire (American Orthodontics) and the appliance was kept in the mouth without being activated for 3 months.
Rapid Maxillary Expansion Treatment with Hybrid hyrax RME applianceDevice
The patients were treated with a Hybrid hyrax RME appliance containing a Hyrax expansion screw positioned parallel to the second premolars and mini-screws. RME activation was performed twice a day for the first week and then once per day. When it was decided that the expansion was sufficient (until the palatal tubercles of the upper molars came into contact with the buccal tubercles of the lower molars), the screw was fixed with the 0.012-inch ligature wire (American Orthodontics) and the appliance was kept in the mouth without being activated for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Tooth-borne RME appliance (Hyrax) | Experimental | In the Tooth-borne RME expander group, bands were placed to the maxillary right and left upper 1st premolar and 1st molar teeth. The impression of the upper jaw was obtained with the bands in mouth by using alginate impression material. In the laboratory process, a hyrax (Forestadent, Pforzheim, Germany; Forestadent USA, St Louis, Missouri, USA) expansion appliance with an expansion screw in the middle was prepared on the models by the same technician under standard conditions.
RME activation was performed twice a day for the first week and then once per day. When it was decided that the expansion was sufficient (until the palatal tubercles of the upper molars came into contact with the buccal tubercles of the lower molars), the screw was fixed with the 0.012-inch ligature wire (American Orthodontics) and the appliance was kept in the mouth without being activated for 3 months. Receives: Device: Rapid Maxillary Expansion Treatment with Tooth-borne RME appliance (Hyrax); Device: Rapid Maxillary Expansion Treatment with Hybrid hyrax RME appliance |
| Hybrid hyrax RME appliance | Experimental | Rapid Maxillary Expansion Treatment. In the Hybrid hyrax RME appliance group, mini-screws of 2 mm diameter and 9 mm length (Benefit mini-implants; PSM Medical Solutions; Tuttlingen, Germany) were placed 3 mm posterior and 1 to 5 mm paramedian to the incisive foramina.
RME activation was performed twice a day for the first week and then once per day. When it was decided that the expansion was sufficient (until the palatal tubercles of the upper molars came into contact with the buccal tubercles of the lower molars), the screw was fixed with the 0.012-inch ligature wire (American Orthodontics) and the appliance was kept in the mouth without being activated for 3 months. Receives: Device: Rapid Maxillary Expansion Treatment with Tooth-borne RME appliance (Hyrax); Device: Rapid Maxillary Expansion Treatment with Hybrid hyrax RME appliance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increasing soft tissue facial measurement-1
Increasing anterior face height
Measured: At baseline and after 3 months retention period
Increasing soft tissue facial measurement-2
Increasing upper lip length
Measured: At baseline and after 3 months retention period
Increasing soft tissue facial measurement-3
Increasing lower face height
Measured: At baseline and after 3 months retention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start20 May 2016
- Primary completion14 Feb 2017
- Study completion17 Jul 2017
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
- Model description
- 2-arm parallel trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gökçenur Gökçe
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gökçenur Gökçe, Izmir Katip Celebi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04828213
- Sponsor's protocol ID
- 2017-GAP-DİŞF-0003
- Status last verified
- Mar 2021
- First submitted
- 29 Mar 2021
- Last updated
- 1 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Akan B, Gokce G, Sahan AO, Veli I. Tooth-borne versus tooth-bone-borne rapid maxillary expanders according to a stereophotogrammetric evaluation of facial soft tissues: A randomized clinical trial. Orthod Craniofac Res. 2021 Aug;24(3):438-448. doi: 10.1111/ocr.12509. Epub 2021 Jun 21.
PubMed 34105880
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tooth-Borne Versus Tooth-Bone-Borne Rapid Maxillary Expanders: A Stereophotogrammetric Evaluation of Soft Tissues
- ClinicalTrials.gov ID
- NCT04828213
- Acronym / sponsor ID
- 2017-GAP-DİŞF-0003
- Conditions
- Posterior Crossbite
- Keywords
- stereophotogrammetry, Tooth-bone-borne rapid maxillary expansion, skeletal anchorage, mini-screws
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Gökçenur GökçeUniversity, hospital or other
- Study start
- 20 May 2016 (actual)
- Primary completion
- 14 Feb 2017 (actual)
- Study completion
- 17 Jul 2017 (actual)
- First posted
- 1 Apr 2021 (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 force exerted by the rapid maxillary expansion (RME) appliances provides expansion of the transverse dimension by splitting of the midpalatal suture. This expansion results in three-dimensional (3D) changes in maxillary position which also effects circummaxillary surrounding structures. The aim of this randomized clinical trial (RCT) was to evaluate the effects of tooth-borne and tooth-bone-borne rapid maxillary expansion (RME) on soft tissue with stereophotogrammetry.
Detailed description
Introduction: To evaluate the effects of tooth-borne and tooth-bone-borne rapid maxillary expansion (RME) on soft tissue with stereophotogrammetry. Methods: 32 patients (15 males, 17 females) who met inclusion criteria were divided into two groups. In the first group, tooth-borne RME appliance (Hyrax) was applied to 16 patients (9 males, 7 females mean age 13.4 ± 1.3 years) and in the second group, tooth-bone-borne RME appliance (Hybrid Hyrax) was applied to 16 patients (6 males, 10 females mean age 13.05 ±1.24 years). A simple electronically generated randomization was performed before trial commencement using the Random Allocation Software program. Allocation concealment involved numbered, sealed, and opaque envelopes prepared before trial commencement. One envelope was sequentially opened for each participant during recruitment. Each envelope contained a card with the name of 1 expander. The initials of the name of the participant, the type of expander, and the date of allocation were identified in the external surface of the envelope. One operator was responsible for the randomization process, allocation concealment, and implementation. The primary outcomes of this study was assessment of changes in soft tissues before RME (T0) and post-retention (T1) period by stereophotogrammetry. Independent and dependent sample t tests were used to compare intra- and inter-group differences at P<0.05 significance level.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 2-arm parallel trial
| Arm | Type | Receives |
|---|---|---|
| Tooth-borne RME appliance (Hyrax) | Experimental | Device: Rapid Maxillary Expansion Treatment with Tooth-borne RME appliance (Hyrax), Device: Rapid Maxillary Expansion Treatment with Hybrid hyrax RME applianceIn the Tooth-borne RME expander group, bands were placed to the maxillary right and left upper 1st premolar and 1st molar teeth. The impression of the upper jaw was obtained with the bands in mouth by using alginate impression material. In the laboratory process, a hyrax (Forestadent, Pforzheim, Germany; Forestadent USA, St Louis, Missouri, USA) expansion appliance with an expansion screw in the middle was prepared on the models by the same technician under standard conditions. RME activation was performed twice a day for the first week and then once per day. When it was decided that the expansion was sufficient (until the palatal tubercles of the upper molars came into contact with the buccal tubercles of the lower molars), the screw was fixed with the 0.012-inch ligature wire (American Orthodontics) and the appliance was kept in the mouth without being activated for 3 months. |
| Hybrid hyrax RME appliance | Experimental | Device: Rapid Maxillary Expansion Treatment with Tooth-borne RME appliance (Hyrax), Device: Rapid Maxillary Expansion Treatment with Hybrid hyrax RME applianceRapid Maxillary Expansion Treatment. In the Hybrid hyrax RME appliance group, mini-screws of 2 mm diameter and 9 mm length (Benefit mini-implants; PSM Medical Solutions; Tuttlingen, Germany) were placed 3 mm posterior and 1 to 5 mm paramedian to the incisive foramina. RME activation was performed twice a day for the first week and then once per day. When it was decided that the expansion was sufficient (until the palatal tubercles of the upper molars came into contact with the buccal tubercles of the lower molars), the screw was fixed with the 0.012-inch ligature wire (American Orthodontics) and the appliance was kept in the mouth without being activated for 3 months. |
Who may qualify
- Ages
- 12 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- No previous tonsillar, nasal or adenoid surgery and orthodontic treatment,
- Bilateral crossbite and need for RME,
- Maxillary and mandibular permanent teeth fully erupted,
- Willingness to participate in the study
Key exclusion criteria (3 listed)
- the presence of adenotonsillectomy due to tonsillar hypertrophy or adenoidal hypertrophy
- Having nasal/nasopharyngeal /oropharyngeal pathologies, craniofacial syndromes, systemic disease, poor oral hygiene,
- History of previous orthodontic treatment.
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 Expansion Treatment with Tooth-borne RME appliance (Hyrax)The patients were treated with a expansion appliance containing a Hyrax expansion screw positioned parallel to the second premolars and were used to correct the posterior crossbite. RME activation was performed twice a day for the first week and then once per day. When it was decided that the expansion was sufficient (until the palatal tubercles of the upper molars came into contact with the buccal tubercles of the lower molars), the screw was fixed with the 0.012-inch ligature wire (American Orthodontics) and the appliance was kept in the mouth without being activated for 3 months. | Device | Hybrid hyrax RME appliance, Tooth-borne RME appliance (Hyrax) |
| Rapid Maxillary Expansion Treatment with Hybrid hyrax RME applianceThe patients were treated with a Hybrid hyrax RME appliance containing a Hyrax expansion screw positioned parallel to the second premolars and mini-screws. RME activation was performed twice a day for the first week and then once per day. When it was decided that the expansion was sufficient (until the palatal tubercles of the upper molars came into contact with the buccal tubercles of the lower molars), the screw was fixed with the 0.012-inch ligature wire (American Orthodontics) and the appliance was kept in the mouth without being activated for 3 months. | Device | Hybrid hyrax RME appliance, Tooth-borne RME appliance (Hyrax) |
Primary outcome
Increasing soft tissue facial measurement-1
Time frame: At baseline and after 3 months retention period
Increasing anterior face height
Increasing soft tissue facial measurement-2
Time frame: At baseline and after 3 months retention period
Increasing upper lip length
Increasing soft tissue facial measurement-3
Time frame: At baseline and after 3 months retention period
Increasing lower face height
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 1 Apr 2021.
- Derived from this study: PubMed 34105880Akan B, Gokce G, Sahan AO, Veli I. Tooth-borne versus tooth-bone-borne rapid maxillary expanders according to a stereophotogrammetric evaluation of facial soft tissues: A randomized clinical trial. Orthod Craniofac Res. 2021 Aug;24(3):438-448. doi: 10.1111/ocr.12509. Epub 2021 Jun 21.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Rapid Maxillary Expansion Treatment with Tooth-borne RME appliance (Hyrax) and Rapid Maxillary Expansion Treatment with Hybrid hyrax RME appliance in people with Posterior Crossbite, run by Gökçenur Gökçe.
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 4 inclusion and 3 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 1 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Increasing soft tissue facial measurement-1 (time frame: At baseline and after 3 months retention period). The study lists 3 primary outcomes in all. 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 NCT04828213, 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 1 Apr 2021.