Cross BiteMyo vs FrankelNCT07840053
Evaluation of Myobrace for Crossbite Correction in Mixed Dentition
A study testing Myobrace Interceptive Class III Appliance and Frankel III Functional Regulator in people with Cross Bite, run by Sana'a University at 1 site in Yemen.
Trial summary
This randomized controlled clinical trial will evaluate the effectiveness of the Myobrace appliance in correcting anterior and posterior crossbite in children aged 6 to 10 years during the mixed dentition stage. The study will compare the clinical effects of Myobrace with those of the Frankel III appliance. Read more about this study
- Who is it for?
- Ages 6 to 10 years
- Conditions the study is for
- Cross Bite
- What is being tested?
- Myobrace Interceptive Class III Appliance and Frankel III Functional Regulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteYemen
- Study dates
- 23 Apr 2025to Sep 2027
- Phase
- Interventional
- 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 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Clinical diagnosis of anterior crossbite, posterior crossbite, or both.
- Yemeni children aged 6 to 10 years.
- Children in the mixed dentition stage.
- No history of prior orthodontic treatment.
Who cannot join
- Children with craniofacial anomalies, such as cleft lip and palate.
- Children with severe jaw misalignment requiring complex therapy.
- Children with complete permanent dentition.
- Children currently undergoing orthodontic treatment
- Children or parents/guardians unwilling to provide informed consent or participate in the study.
- Children with predicted or observed poor compliance, including behavioral issues that may interfere with treatment or study procedures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Myobrace Appliance in Correcting Crossbite During the Mixed Dentition Stage: A Randomized, Controlled Clinical Trial
This randomized controlled clinical trial will evaluate the effectiveness of the Myobrace appliance in correcting anterior and posterior crossbite in children aged 6 to 10 years during the mixed dentition stage. The study will compare the clinical effects of Myobrace with those of the Frankel III appliance. The study will assess changes in occlusion, skeletal and dentoalveolar relationships, and soft tissue characteristics before and after treatment. The study will also evaluate the effectiveness of the two treatment approaches in improving crossbite correction and related orthodontic outcomes.
Read the detailed description
Crossbite is a common malocclusion in children and may involve anterior or posterior teeth. Early management during the mixed dentition stage may help improve the occlusal relationship and reduce the potential for progression of the malocclusion.
This randomized controlled clinical trial is designed to evaluate the effectiveness of the Myobrace appliance for the correction of crossbite in children aged 6 to 10 years during the mixed dentition stage. The study will compare treatment with the Myobrace appliance with treatment using the Frankel III appliance.
Eligible children with anterior and/or posterior crossbite will be allocated to one of the treatment groups according to the study randomization protocol. Participants will receive the assigned appliance and will be followed throughout the treatment period according to the study protocol.
Treatment effectiveness will be evaluated by comparing clinical and orthodontic measurements obtained before and after treatment. The assessment will include correction of the crossbite and changes in skeletal, dentoalveolar, and soft tissue relationships. Cephalometric analysis will be used to assess relevant skeletal, dentoalveolar, and soft tissue changes.
The study will provide clinical information regarding the effectiveness of Myobrace treatment for crossbite correction during the mixed dentition stage and will allow comparison of its treatment effects with those of the Frankel III appliance.
- Conditions
- Cross Bite
- Being tested
- Myobrace Interceptive Class III Appliance, Frankel III Functional Regulator
- Keywords
- Crossbite, Anterior Crossbite, Posterior Crossbite, Myobrace, Frankel III, Mixed Dentition, Interceptive Orthodontics
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myobrace Interceptive Class III ApplianceDevice
Participants will receive the Myobrace® Interceptive Class III appliance during the mixed dentition stage. The appliance will be used according to the study treatment protocol, with instructions for approximately 1-2 hours of daytime wear and overnight wear, together with daily myofunctional exercises and instructions regarding nasal breathing, tongue posture, swallowing, and lip competence. Treatment will continue until crossbite correction is achieved or for a maximum of 18 months, whichever occurs first.
Frankel III Functional RegulatorDevice
Also called FR-III
Participants will receive the Frankel III (FR-III) functional regulator during the mixed dentition stage. The appliance will be used according to the study treatment protocol. Treatment will continue until crossbite correction is achieved or for a maximum of 18 months, whichever occurs first. Clinical and cephalometric assessments will be performed before and after treatment to evaluate changes in skeletal, dentoalveolar, and occlusal relationships.
| Study group | Role | What they receive |
|---|---|---|
| Myobrace Group | Experimental | Participants assigned to this arm will receive the Myobrace® Interceptive Class III appliance during the mixed dentition stage. Participants will be instructed to wear the appliance for approximately 1-2 hours during the day and overnight, together with daily myofunctional exercises and instructions regarding nasal breathing, tongue posture, swallowing, and lip competence. Treatment will continue until crossbite correction is achieved or for a maximum of 18 months, whichever occurs first. Receives: Device: Myobrace Interceptive Class III Appliance |
| Frankel III Group | Active comparator | Participants assigned to this arm will receive the Frankel III (FR-III) functional regulator during the mixed dentition stage. The appliance will be used according to the clinical treatment protocol. Treatment will continue until crossbite correction is achieved or for a maximum of 18 months, whichever occurs first. Clinical and cephalometric assessments will be performed before and after treatment to evaluate changes in skeletal, dentoalveolar, and occlusal relationships. Receives: Device: Frankel III Functional Regulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Crossbite Correction Status
Change in occlusal crossbite status from baseline to treatment completion, assessed clinically by the presence or absence of anterior and/or posterior crossbite. Complete correction is defined as establishment of a normal anterior and/or posterior buccolingual occlusal relationship according to the type of crossbite present at baseline. The change will be assessed for each participant by comparing the post-treatment crossbite status with the participant's baseline status. The changes will then be compared between the Myobrace and Frankel III groups.
Baseline and at treatment completion, defined as when anterior crossbite correction is achieved or at 18 months, whichever occurs first.
Measured: Baseline, and up to 18 months
Secondary outcomes (32)
Change in Overjet
Change from baseline in overjet, measured in millimeters (mm) as the horizontal distance between the maxillary and mandibular incisors. The change will be calculated for each participant by comparing the post-treatment overjet value with the participant's baseline value. The changes will then be compared between the Myobrace and Frankel III groups. Baseline and at treatment completion, defined as when anterior crossbite correction is achieved or at 18 months, whichever occurs first.
Measured: Baseline, and up to 18 months.
Change in Overbite
Change from baseline in overbite, measured in millimeters (mm) as the vertical overlap between the maxillary and mandibular incisors. The change will be calculated for each participant by comparing the post-treatment overbite value with the participant's baseline value. The changes will then be compared between the Myobrace and Frankel III groups. Baseline and at treatment completion, defined as when anterior crossbite correction is achieved or at 18 months, whichever occurs first.
Measured: Baseline, and up to 18 months.
Anterior Crossbite Correction
Correction of anterior crossbite at treatment completion, assessed for each participant by comparing the post-treatment anterior crossbite status with the participant's baseline status. Correction is defined as establishment of a positive or normal horizontal overlap between the maxillary and mandibular anterior teeth that were in crossbite at baseline. The proportion of participants achieving anterior crossbite correction will then be compared between the Myobrace and Frankel III groups. Baseline and at treatment completion, defined as when anterior crossbite correction is achieved or at 18 months, whichever occurs first.
Measured: Baseline, and up to 18 months.
Posterior Crossbite Correction
Correction of posterior crossbite at treatment completion, assessed for each participant by comparing the post-treatment posterior crossbite status with the participant's baseline status. Correction is defined as establishment of a normal transverse buccolingual relationship between the maxillary and mandibular posterior teeth that were in crossbite at baseline. The proportion of participants achieving posterior crossbite correction will then be compared between the Myobrace and Frankel III groups. Baseline and at treatment completion, defined as when anterior crossbite correction is achieved or at 18 months, whichever occurs first.
Measured: Baseline, and up to 18 months.
Change in ANB
Change from baseline in the ANB angle, measured in degrees (°) on standardized lateral cephalometric radiographs. The change will be calculated for each participant by comparing the post-treatment ANB value with the participant's baseline value. The changes will then be compared between the Myobrace and Frankel III groups. Baseline and at treatment completion, defined as when anterior crossbite correction is achieved or at 18 months, whichever occurs first.
Measured: Baseline, and up to 18 months.
Change in SNA
Change from baseline in the SNA angle, measured in degrees (°) on standardized lateral cephalometric radiographs. The change will be calculated for each participant by comparing the post-treatment SNA value with the participant's baseline value. The changes will then be compared between the Myobrace and Frankel III groups. Baseline and at treatment completion, defined as when anterior crossbite correction is achieved or at 18 months, whichever occurs first.
Measured: Baseline, and up to 18 months.
Change in SNB
Change from baseline in the SNB angle, measured in degrees (°) on standardized lateral cephalometric radiographs. The change will be calculated for each participant by comparing the post-treatment SNB value with the participant's baseline value. The changes will then be compared between the Myobrace and Frankel III groups. Baseline and at treatment completion, defined as when anterior crossbite correction is achieved or at 18 months, whichever occurs first.
Measured: Baseline, and up to 18 months.
Change in Wits Appraisal
Change from baseline in Wits appraisal, measured in millimeters (mm) on standardized lateral cephalometric radiographs. The change will be calculated for each participant by comparing the post-treatment Wits appraisal value with the participant's baseline value. The changes will then be compared between the Myobrace and Frankel III groups. Baseline and at treatment completion, defined as when anterior crossbite correction is achieved or at 18 months, whichever occurs first.
Measured: Baseline, and up to 18 months.
Change in SN-MP
Change from baseline in the SN-MP angle, measured in degrees (°) on standardized lateral cephalometric radiographs. The change will be calculated for each participant by comparing the post-treatment SN-MP value with the participant's baseline value. The changes will then be compared between the Myobrace and Frankel III groups. Baseline and at treatment completion, defined as when anterior crossbite correction is achieved or at 18 months, whichever occurs first.
Measured: Baseline, and up to 18 months.
Change in SN-OP
Change from baseline in the SN-OP angle, measured in degrees (°) on standardized lateral cephalometric radiographs. The change will be calculated for each participant by comparing the post-treatment SN-OP value with the participant's baseline value. The changes will then be compared between the Myobrace and Frankel III groups. Baseline and at treatment completion, defined as when anterior crossbite correction is achieved or at 18 months, whichever occurs first.
Measured: Baseline, and up to 18 months.
Change in Ar-Go-Me (Gonial Angle)
Change from baseline in the Ar-Go-Me (gonial) angle, measured in degrees (°) on standardized lateral cephalometric radiographs. The change will be calculated for each participant by comparing the post-treatment Ar-Go-Me value with the participant's baseline value. The changes will then be compared between the Myobrace and Frankel III groups. Baseline and at treatment completion, defined as when anterior crossbite correction is achieved or at 18 months, whichever occurs first.
Measured: Baseline, and up to 18 months.
Change in Y-axis (Por-Gns)
Change from baseline in the Y-axis (Por-Gns) angle, measured in degrees (°) on standardized lateral cephalometric radiographs. The change will be calculated for each participant by comparing the post-treatment Y-axis value with the participant's baseline value. The changes will then be compared between the Myobrace and Frankel III groups. Baseline and at treatment completion, defined as when anterior crossbite correction is achieved or at 18 months, whichever occurs first.
Measured: Baseline, and up to 18 months.
Change in FMA
Change from baseline in the FMA (Frankfort-Mandibular Plane Angle), measured in degrees (°) on standardized lateral cephalometric radiographs. The change will be calculated for each participant by comparing the post-treatment FMA value with the participant's baseline value. The changes will then be compared between the Myobrace and Frankel III groups. Baseline and at treatment completion, defined as when anterior crossbite correction is achieved or at 18 months, whichever occurs first.
Measured: Baseline, and up to 18 months.
Change in IMPA
Change from baseline in the IMPA (Incisor to Mandibular Plane Angle), measured in degrees (°) on standardized lateral cephalometric radiographs. The change will be calculated for each participant by comparing the post-treatment IMPA value with the participant's baseline value. The changes will then be compared between the Myobrace and Frankel III groups. Baseline and at treatment completion, defined as when anterior crossbite correction is achieved or at 18 months, whichever occurs first.
Measured: Baseline, and up to 18 months.
Change in FMIA
Change from baseline in the FMIA (Frankfort-Mandibular Incisor Angle), measured in degrees (°) on standardized lateral cephalometric radiographs. The change will be calculated for each participant by comparing the post-treatment FMIA value with the participant's baseline value. The changes will then be compared between the Myobrace and Frankel III groups. Baseline and at treatment completion, defined as when anterior crossbite correction is achieved or at 18 months, whichever occurs first.
Measured: Baseline, and up to 18 months.
Change in S-Go Ratio
Change from baseline in the S-Go ratio, expressed as a percentage (%) on standardized lateral cephalometric radiographs. The ratio represents the posterior facial height (S-Go) relative to the anterior facial height (N-Me). The change will be calculated for each participant by comparing the post-treatment S-Go ratio with the participant's baseline ratio. The changes will then be compared between the Myobrace and Frankel III groups. Baseline and at treatment completion, defined as when anterior crossbite correction is achieved or at 18 months, whichever occurs first.
Measured: Baseline, and up to 18 months.
Change in UI-SN
Change from baseline in the UI-SN angle (Upper Incisor to SN Plane), measured in degrees (°) on standardized lateral cephalometric radiographs. The change will be calculated for each participant by comparing the post-treatment UI-SN value with the participant's baseline value. The changes will then be compared between the Myobrace and Frankel III groups. Baseline and at treatment completion, defined as when anterior crossbite correction is achieved or at 18 months, whichever occurs first.
Measured: Baseline, and up to 18 months.
Change in Interincisal Angle (U1/L1)
Change from baseline in the interincisal angle (U1/L1), measured in degrees (°) on standardized lateral cephalometric radiographs. The change will be calculated for each participant by comparing the post-treatment interincisal angle value with the participant's baseline value. The changes will then be compared between the Myobrace and Frankel III groups. Baseline and at treatment completion, defined as when anterior crossbite correction is achieved or at 18 months, whichever occurs first.
Measured: Baseline, and up to 18 months.
Change in U1/NA Angle
Change from baseline in the U1/NA angle (Upper Incisor to NA), measured in degrees (°) on standardized lateral cephalometric radiographs. The change will be calculated for each participant by comparing the post-treatment U1/NA angle value with the participant's baseline value. The changes will then be compared between the Myobrace and Frankel III groups. Baseline and at treatment completion, defined as when anterior crossbite correction is achieved or at 18 months, whichever occurs first.
Measured: Baseline, and up to 18 months.
Change in U1/NA Linear Measurement
Change from baseline in the linear U1/NA measurement (Upper Incisor to NA), measured in millimeters (mm) on standardized lateral cephalometric radiographs. The change will be calculated for each participant by comparing the post-treatment U1/NA linear measurement with the participant's baseline value. The changes will then be compared between the Myobrace and Frankel III groups. Baseline and at treatment completion, defined as when anterior crossbite correction is achieved or at 18 months, whichever occurs first.
Measured: Baseline, and up to 18 months.
Change in L1/NB Angle
Change from baseline in the L1/NB angle (Lower Incisor to NB), measured in degrees (°) on standardized lateral cephalometric radiographs. The change will be calculated for each participant by comparing the post-treatment L1/NB angle value with the participant's baseline value. The changes will then be compared between the Myobrace and Frankel III groups. Baseline and at treatment completion, defined as when anterior crossbite correction is achieved or at 18 months, whichever occurs first.
Measured: Baseline, and up to 18 months
Change in L1/NB Linear Measurement
Change from baseline in the linear L1/NB measurement (Lower Incisor to NB), measured in millimeters (mm) on standardized lateral cephalometric radiographs. The change will be calculated for each participant by comparing the post-treatment L1/NB linear measurement with the participant's baseline value. The changes will then be compared between the Myobrace and Frankel III groups. Baseline and at treatment completion, defined as when anterior crossbite correction is achieved or at 18 months, whichever occurs first.
Measured: Baseline, and up to 18 months.
Change in Nasolabial Angle (Cotg-Sn-Ls)
Change from baseline in the nasolabial angle (Cotg-Sn-Ls), measured in degrees (°) on standardized lateral cephalometric radiographs. The change will be calculated for each participant by comparing the post-treatment nasolabial angle value with the participant's baseline value. The changes will then be compared between the Myobrace and Frankel III groups. Baseline and at treatment completion, defined as when anterior crossbite correction is achieved or at 18 months, whichever occurs first.
Measured: Baseline, and up to 18 months.
Change in Z Angle
Change from baseline in the Z angle (Merritt), measured in degrees (°) on standardized lateral cephalometric radiographs. The change will be calculated for each participant by comparing the post-treatment Z angle value with the participant's baseline value. The changes will then be compared between the Myobrace and Frankel III groups. Baseline and at treatment completion, defined as when anterior crossbite correction is achieved or at 18 months, whichever occurs first.
Measured: Baseline, and up to 18 months.
Change in N-Pog-H Line (H Angle)
Change from baseline in the N-Pog-H angle (H angle, Holdaway), measured in degrees (°) on standardized lateral cephalometric radiographs. The change will be calculated for each participant by comparing the post-treatment N-Pog-H angle value with the participant's baseline value. The changes will then be compared between the Myobrace and Frankel III groups. Baseline and at treatment completion, defined as when anterior crossbite correction is achieved or at 18 months, whichever occurs first.
Measured: Baseline, and up to 18 months.
Change in Ls-NsPog (U lip /E line)
Change from baseline in the Ls-NsPog (upper lip to E-line) measurement, measured in millimeters (mm) on standardized lateral cephalometric radiographs. The change will be calculated for each participant by comparing the post-treatment Ls-NsPog value with the participant's baseline value. The changes will then be compared between the Myobrace and Frankel III groups. Baseline and at treatment completion, defined as when anterior crossbite correction is achieved or at 18 months, whichever occurs first.
Measured: Baseline, and up to 18 months
Change in Li-NsPog (Lower Lip / E-Line)
Change from baseline in the Li-NsPog (lower lip to E-line) measurement, measured in millimeters (mm) on standardized lateral cephalometric radiographs. The change will be calculated for each participant by comparing the post-treatment Li-NsPog value with the participant's baseline value. The changes will then be compared between the Myobrace and Frankel III groups. Baseline and at treatment completion, defined as when anterior crossbite correction is achieved or at 18 months, whichever occurs first.
Measured: Baseline, and up to 18 months.
Change in Sn-Stm : Stm-Me Ratio
Change from baseline in the Sn-Stm : Stm-Me ratio (Legan and Burstone), expressed as a percentage (%), representing the ratio of the upper lip height (Sn-Stm) to the lower lip and chin height (Stm-Me) on standardized lateral cephalometric radiographs. The change will be calculated for each participant by comparing the post-treatment ratio with the participant's baseline ratio. The changes will then be compared between the Myobrace and Frankel III groups. Baseline and at treatment completion, defined as when anterior crossbite correction is achieved or at 18 months, whichever occurs first.
Measured: Baseline, and up to 18 months.
Change in Gl-Sn-Pog (Facial Contour Angle)
Change from baseline in the Gl-Sn-Pog facial contour angle (Glabella-Subnasale-Pogonion), representing the soft tissue angle of facial convexity, measured in degrees (°) on standardized lateral cephalometric radiographs. The change will be calculated for each participant by comparing the post-treatment Gl-Sn-Pog angle value with the participant's baseline value. The changes will then be compared between the Myobrace and Frankel III groups. Baseline and at treatment completion, defined as when anterior crossbite correction is achieved or at 18 months, whichever occurs first.
Measured: Baseline, and up to 18 months.
Change in UFH (Upper Facial Height)
Change from baseline in the upper facial height (UFH), measured in millimeters (mm) on standardized lateral cephalometric radiographs. The change will be calculated for each participant by comparing the post-treatment UFH value with the participant's baseline value. The changes will then be compared between the Myobrace and Frankel III groups. Baseline and at treatment completion, defined as when anterior crossbite correction is achieved or at 18 months, whichever occurs first.
Measured: Baseline, and up to 18 months.
Change in LFH (Lower Facial Height)
Change from baseline in the lower facial height (LFH), measured in millimeters (mm) on standardized lateral cephalometric radiographs. The change will be calculated for each participant by comparing the post-treatment LFH value with the participant's baseline value. The changes will then be compared between the Myobrace and Frankel III groups. Baseline and at treatment completion, defined as when anterior crossbite correction is achieved or at 18 months, whichever occurs first.
Measured: Baseline, and up to 18 months.
Change in UFH: LFH ratio
Change from baseline in the UFH: LFH ratio (Upper Facial Height to Lower Facial Height), expressed as a percentage (%) on standardized lateral cephalometric radiographs. The ratio represents the upper facial height (UFH) relative to the lower facial height (LFH). The change will be calculated for each participant by comparing the post-treatment UFH:LFH ratio with the participant's baseline ratio. The changes will then be compared between the Myobrace and Frankel III groups. Baseline and at treatment completion, defined as when anterior crossbite correction is achieved or at 18 months, whichever occurs first.
Measured: Baseline, and up to 18 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study start23 Apr 2025
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Cross BiteStudies 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
- Group 1 will receive the Myobrace® Interceptive Class III appliance, and Group 2 will receive the Frankel III appliance. Treatment will be provided during the mixed dentition stage, with pre-treatment and post-treatment assessments performed using clinical examination, photographs, study models, and lateral cephalometric radiographs.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sana'a University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, tharwa Ali Mokred AL-awadi, Sana'a University
- Investigators
- Dr.Tharwa Alawadi, BDS, MSc, Study director, Sana'a University, Faculty of DentistryKhaled AL-Haddad, Professor, Study chair, Sana'a University, Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07840053
- Sponsor's protocol ID
- PE:01/09/2025
- Acronym
- Myo vs Frankel
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers. The study data will be used for the purposes of the current research and reported in aggregate form to protect participant confidentiality and privacy.
Publications
Pham TT, Tran BC, Pham TTH. Effectiveness of Myobrace Therapy in Correcting Anterior Crossbite in Early Mixed Dentition: A Retrospective Study. Int J Clin Pediatr Dent. 2025 Oct;18(10):1243-1248. doi: 10.5005/jp-journals-10005-3281. Epub 2025 Oct 18.
PubMed 41211360Mareddy AR, Reddy VN, Done V, Rehaman T, Vemula ADNK, Narahari S, Jukanti S. Early Intervention for Malocclusion: Role of Myobrace in Children Aged 6-10 Years. Int J Clin Pediatr Dent. 2025 Aug;18(8):956-963. doi: 10.5005/jp-journals-10005-3193. Epub 2025 Sep 4.
PubMed 40989970Aytan S, Yukay F, Cigler S, Enacar A, Aksoy A, Telli AE. [Frankel III appliance]. Turk Ortodonti Derg. 1989 Nov;2(2):338-45. Turkish.
PubMed 2489168Perillo L, Vitale M, Masucci C, D'Apuzzo F, Cozza P, Franchi L. Comparisons of two protocols for the early treatment of Class III dentoskeletal disharmony. Eur J Orthod. 2016 Feb;38(1):51-56. doi: 10.1093/ejo/cjv010. Epub 2015 Mar 13.
PubMed 25770942Borrie F, Bearn D. Early correction of anterior crossbites: a systematic review. J Orthod. 2011 Sep;38(3):175-84. doi: 10.1179/14653121141443.
PubMed 21875991Kecik D, Kocadereli I, Saatci I. Evaluation of the treatment changes of functional posterior crossbite in the mixed dentition. Am J Orthod Dentofacial Orthop. 2007 Feb;131(2):202-15. doi: 10.1016/j.ajodo.2005.03.030.
PubMed 17276861Wiedel AP, Bondemark L. Stability of anterior crossbite correction: a randomized controlled trial with a 2-year follow-up. Angle Orthod. 2015 Mar;85(2):189-95. doi: 10.2319/041114-266.1. Epub 2014 Jul 8.
PubMed 25004240Bahrun AN, Erwansyah E, Ranggang BM, Pawinru A, Nasir M. Myofunctional orthodontic therapy in Class III dentoskeletal malocclusion using Myobrace appliance and inclined bite plane: Case report. Indonesian Journal of Orthodontics Case Report. 2024;1(1):16-24.
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Myobrace Appliance in Correcting Crossbite During the Mixed Dentition Stage: A Randomized, Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07840053
- Acronym / sponsor ID
- Myo vs Frankel / PE:01/09/2025
- Conditions
- Cross Bite
- Keywords
- Crossbite, Anterior Crossbite, Posterior Crossbite, Myobrace, Frankel III, Mixed Dentition, Interceptive Orthodontics
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Sana'a UniversityUniversity, hospital or other
- Study start
- 23 Apr 2025 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 24 Sep 2026 (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.
This randomized controlled clinical trial will evaluate the effectiveness of the Myobrace appliance in correcting anterior and posterior crossbite in children aged 6 to 10 years during the mixed dentition stage. The study will compare the clinical effects of Myobrace with those of the Frankel III appliance. The study will assess changes in occlusion, skeletal and dentoalveolar relationships, and soft tissue characteristics before and after treatment. The study will also evaluate the effectiveness of the two treatment approaches in improving crossbite correction and related orthodontic outcomes.
Detailed description
Crossbite is a common malocclusion in children and may involve anterior or posterior teeth. Early management during the mixed dentition stage may help improve the occlusal relationship and reduce the potential for progression of the malocclusion.
This randomized controlled clinical trial is designed to evaluate the effectiveness of the Myobrace appliance for the correction of crossbite in children aged 6 to 10 years during the mixed dentition stage. The study will compare treatment with the Myobrace appliance with treatment using the Frankel III appliance.
Eligible children with anterior and/or posterior crossbite will be allocated to one of the treatment groups according to the study randomization protocol. Participants will receive the assigned appliance and will be followed throughout the treatment period according to the study protocol.
Treatment effectiveness will be evaluated by comparing clinical and orthodontic measurements obtained before and after treatment. The assessment will include correction of the crossbite and changes in skeletal, dentoalveolar, and soft tissue relationships. Cephalometric analysis will be used to assess relevant skeletal, dentoalveolar, and soft tissue changes.
The study will provide clinical information regarding the effectiveness of Myobrace treatment for crossbite correction during the mixed dentition stage and will allow comparison of its treatment effects with those of the Frankel III appliance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Group 1 will receive the Myobrace® Interceptive Class III appliance, and Group 2 will receive the Frankel III appliance. Treatment will be provided during the mixed dentition stage, with pre-treatment and post-treatment assessments performed using clinical examination, photographs, study models, and lateral cephalometric radiographs.
| Arm | Type | Receives |
|---|---|---|
| Myobrace Group | Experimental | Device: Myobrace Interceptive Class III ApplianceParticipants assigned to this arm will receive the Myobrace® Interceptive Class III appliance during the mixed dentition stage. Participants will be instructed to wear the appliance for approximately 1-2 hours during the day and overnight, together with daily myofunctional exercises and instructions regarding nasal breathing, tongue posture, swallowing, and lip competence. Treatment will continue until crossbite correction is achieved or for a maximum of 18 months, whichever occurs first. |
| Frankel III Group | Active comparator | Device: Frankel III Functional RegulatorParticipants assigned to this arm will receive the Frankel III (FR-III) functional regulator during the mixed dentition stage. The appliance will be used according to the clinical treatment protocol. Treatment will continue until crossbite correction is achieved or for a maximum of 18 months, whichever occurs first. Clinical and cephalometric assessments will be performed before and after treatment to evaluate changes in skeletal, dentoalveolar, and occlusal relationships. |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Clinical diagnosis of anterior crossbite, posterior crossbite, or both.
- Yemeni children aged 6 to 10 years.
- Children in the mixed dentition stage.
- No history of prior orthodontic treatment.
Key exclusion criteria (6 listed)
- Children with craniofacial anomalies, such as cleft lip and palate.
- Children with severe jaw misalignment requiring complex therapy.
- Children with complete permanent dentition.
- Children currently undergoing orthodontic treatment
- Children or parents/guardians unwilling to provide informed consent or participate in the study.
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 |
|---|---|---|
| Myobrace Interceptive Class III ApplianceParticipants will receive the Myobrace® Interceptive Class III appliance during the mixed dentition stage. The appliance will be used according to the study treatment protocol, with instructions for approximately 1-2 hours of daytime wear and overnight wear, together with daily myofunctional exercises and instructions regarding nasal breathing, tongue posture, swallowing, and lip competence. Treatment will continue until crossbite correction is achieved or for a maximum of 18 months, whichever occurs first. | Device | Myobrace Group |
| Frankel III Functional RegulatorAlso: FR-IIIParticipants will receive the Frankel III (FR-III) functional regulator during the mixed dentition stage. The appliance will be used according to the study treatment protocol. Treatment will continue until crossbite correction is achieved or for a maximum of 18 months, whichever occurs first. Clinical and cephalometric assessments will be performed before and after treatment to evaluate changes in skeletal, dentoalveolar, and occlusal relationships. | Device | Frankel III Group |
Primary outcome
Change in Crossbite Correction Status
Time frame: Baseline, and up to 18 months
Change in occlusal crossbite status from baseline to treatment completion, assessed clinically by the presence or absence of anterior and/or posterior crossbite. Complete correction is defined as establishment of a normal anterior and/or posterior buccolingual occlusal relationship according to the type of crossbite present at baseline. The change will be assessed for each participant by comparing the post-treatment crossbite status with the participant's baseline status. The changes will then be compared between the Myobrace and Frankel III groups. Baseline and at treatment completion, defined as when anterior crossbite correction is achieved or at 18 months, whichever occurs first.
32 secondary outcomes
Change in Overjet
Time frame: Baseline, and up to 18 months.
Change in Overbite
Time frame: Baseline, and up to 18 months.
Anterior Crossbite Correction
Time frame: Baseline, and up to 18 months.
Posterior Crossbite Correction
Time frame: Baseline, and up to 18 months.
Change in ANB
Time frame: Baseline, and up to 18 months.
Change in SNA
Time frame: Baseline, and up to 18 months.
Change in SNB
Time frame: Baseline, and up to 18 months.
Change in Wits Appraisal
Time frame: Baseline, and up to 18 months.
Change in SN-MP
Time frame: Baseline, and up to 18 months.
Change in SN-OP
Time frame: Baseline, and up to 18 months.
Change in Ar-Go-Me (Gonial Angle)
Time frame: Baseline, and up to 18 months.
Change in Y-axis (Por-Gns)
Time frame: Baseline, and up to 18 months.
Change in FMA
Time frame: Baseline, and up to 18 months.
Change in IMPA
Time frame: Baseline, and up to 18 months.
Change in FMIA
Time frame: Baseline, and up to 18 months.
Change in S-Go Ratio
Time frame: Baseline, and up to 18 months.
Change in UI-SN
Time frame: Baseline, and up to 18 months.
Change in Interincisal Angle (U1/L1)
Time frame: Baseline, and up to 18 months.
Change in U1/NA Angle
Time frame: Baseline, and up to 18 months.
Change in U1/NA Linear Measurement
Time frame: Baseline, and up to 18 months.
Change in L1/NB Angle
Time frame: Baseline, and up to 18 months
Change in L1/NB Linear Measurement
Time frame: Baseline, and up to 18 months.
Change in Nasolabial Angle (Cotg-Sn-Ls)
Time frame: Baseline, and up to 18 months.
Change in Z Angle
Time frame: Baseline, and up to 18 months.
Change in N-Pog-H Line (H Angle)
Time frame: Baseline, and up to 18 months.
Change in Ls-NsPog (U lip /E line)
Time frame: Baseline, and up to 18 months
Change in Li-NsPog (Lower Lip / E-Line)
Time frame: Baseline, and up to 18 months.
Change in Sn-Stm : Stm-Me Ratio
Time frame: Baseline, and up to 18 months.
Change in Gl-Sn-Pog (Facial Contour Angle)
Time frame: Baseline, and up to 18 months.
Change in UFH (Upper Facial Height)
Time frame: Baseline, and up to 18 months.
Change in LFH (Lower Facial Height)
Time frame: Baseline, and up to 18 months.
Change in UFH: LFH ratio
Time frame: Baseline, and up to 18 months.
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 24 Sep 2026.
- Background: PubMed 41211360Pham TT, Tran BC, Pham TTH. Effectiveness of Myobrace Therapy in Correcting Anterior Crossbite in Early Mixed Dentition: A Retrospective Study. Int J Clin Pediatr Dent. 2025 Oct;18(10):1243-1248. doi: 10.5005/jp-journals-10005-3281. Epub 2025 Oct 18.
- Background: PubMed 40989970Mareddy AR, Reddy VN, Done V, Rehaman T, Vemula ADNK, Narahari S, Jukanti S. Early Intervention for Malocclusion: Role of Myobrace in Children Aged 6-10 Years. Int J Clin Pediatr Dent. 2025 Aug;18(8):956-963. doi: 10.5005/jp-journals-10005-3193. Epub 2025 Sep 4.
- Background: PubMed 2489168Aytan S, Yukay F, Cigler S, Enacar A, Aksoy A, Telli AE. [Frankel III appliance]. Turk Ortodonti Derg. 1989 Nov;2(2):338-45. Turkish.
- Background: PubMed 25770942Perillo L, Vitale M, Masucci C, D'Apuzzo F, Cozza P, Franchi L. Comparisons of two protocols for the early treatment of Class III dentoskeletal disharmony. Eur J Orthod. 2016 Feb;38(1):51-56. doi: 10.1093/ejo/cjv010. Epub 2015 Mar 13.
- Background: PubMed 21875991Borrie F, Bearn D. Early correction of anterior crossbites: a systematic review. J Orthod. 2011 Sep;38(3):175-84. doi: 10.1179/14653121141443.
- Background: PubMed 17276861Kecik D, Kocadereli I, Saatci I. Evaluation of the treatment changes of functional posterior crossbite in the mixed dentition. Am J Orthod Dentofacial Orthop. 2007 Feb;131(2):202-15. doi: 10.1016/j.ajodo.2005.03.030.
- Background: PubMed 25004240Wiedel AP, Bondemark L. Stability of anterior crossbite correction: a randomized controlled trial with a 2-year follow-up. Angle Orthod. 2015 Mar;85(2):189-95. doi: 10.2319/041114-266.1. Epub 2014 Jul 8.
- BackgroundBahrun AN, Erwansyah E, Ranggang BM, Pawinru A, Nasir M. Myofunctional orthodontic therapy in Class III dentoskeletal malocclusion using Myobrace appliance and inclined bite plane: Case report. Indonesian Journal of Orthodontics Case Report. 2024;1(1):16-24.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers. The study data will be used for the purposes of the current research and reported in aggregate form to protect participant confidentiality and privacy.
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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.
Dr.Tharwa Alawadi, BDS, MSc study director
Sana'a University, Faculty of Dentistry
Khaled AL-Haddad, Professor study chair
Sana'a University, Faculty of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Myobrace Interceptive Class III Appliance and Frankel III Functional Regulator in people with Cross Bite, run by Sana'a University at 1 site in Yemen.
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 6 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 24 Sep 2026. 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 Yemen. 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?
Change in Crossbite Correction Status (time frame: Baseline, and up to 18 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 NCT07840053, which also lists 8 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 24 Sep 2026.