Malocclusion, Angle Class IItwin blockNCT05227469
Myofunctional Therapy Twin Block
A study testing myofunctional therapy in people with Malocclusion, Angle Class II, run by Bezmialem Vakif University at 2 sites in Turkey (Türkiye).
Trial summary
There are situations where orthodontic treatment cannot provide long-term benefits. The proposed orthotropic theory proposes that environmental factors cause malocclusion and genes decide its pattern. Read more about this study
- Who is it for?
- Ages 9 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Malocclusion, Angle Class II
- What is being tested?
- myofunctional therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 18 Oct 2021to 1 Dec 2022
- 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 9 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Having a skeletal Class II relationship (ANB > 4°),
- Skeletal Class II relationship due to mandibular retrognathia (SNB < 78°),
- Overjet is more than 5 mm,
- Normal growth pattern SN-GoGn (32° ± 6°),
- Minimum crowding of the dental arch is 4 mm or less,
- Bilateral Class II molar and canine relationship is at least 3.5 mm,
- Patients who are in MP3 cap period will be taken according to the Tanner-Whitehouse wrist and wrist X-ray method.
Who cannot join
- Having received orthodontic treatment before,
- Having severe maxillary stenosis,
- Severe facial asymmetry according to clinical and x-ray analysis,
- Poor oral hygiene,
- Having mental retardation at a level that will affect the patient's cooperation,
- 7. Having a systemic disease that will affect the orthodontic treatment, 8. Congenital anomaly or syndrome.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Banu Kılıç
Fatih, Istanbul, 34093
Banu Kılıç, 05322432756, bkilic@bezmialem.edu.tr
- Recruiting
Banu Kilic
Istanbul, Fatih, 34844
Banu Kilic, 05322432756, bkilic@bezmialem.edu.tr
About this study
Official title: The Effect of Myofunctional Exercises in Class II Patients
There are situations where orthodontic treatment cannot provide long-term benefits. The proposed orthotropic theory proposes that environmental factors cause malocclusion and genes decide its pattern. The primary aim of this project is to increase the success, aesthetics and permanence of the treatment result by providing the best facial change of the pediatric patients in the MP3cap period, and that myofunctional exercises can be used in addition to orthodontic treatments during the treatment process of the patients.
Read the detailed description
Many studies in recent years have emphasized the importance of the environmental factor as well as the hereditary causes of malocclusion. In particular, the activity and posture of the oral soft tissues have begun to be mentioned more. In the presence of bad habits, there are cases where orthodontic treatment alone is not sufficient and must be combined with myofunctional treatments. There are also many physicians who emphasize the importance of positioning the tongue in contact with the palate during swallowing and resting.
It is known that habits during growth and development cause malocclusions that may occur in the future. It may be possible to acquire some myofunctional exercises as a habit during the growth and development period as a prophylactic solution against malocclusions. In addition to twin block treatment, myofunctional exercises will be given to class II pediatric patients in the MP3cap period, and the effect of exercises on oral soft and hard tissues will be compared at the end of the treatment. The effects of tongue and lip movements on facial development as well as on the treatment process will be examined. Perhaps in the future, everyone can recommend doing myofunctional exercises in addition to tooth brushing.
- Conditions
- Malocclusion, Angle Class II
- Being tested
- myofunctional therapy
- Medical subject headings
- Malocclusion, Angle Class II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
myofunctional therapyBehavioural
In order to confirm that the exercises are done for a sufficient time and are done correctly, the researcher will take video recordings from the participants and examine these recordings every other day. Respondents will be contacted when errors are detected.
| Study group | Role | What they receive |
|---|---|---|
| Skeletal class II twinblock + myofunctional therapy | Experimental | Myofunctional exercises will be prescribed in addition to the standart twin block therapy. Movements will be taught to this group, for which we have prescribed the exercises. It will be ensured that the exercises are done more properly and regularly by taking video recordings every other day from the group that does the exercises twice a day. Incorrect exercises will be corrected by providing feedback. Receives: Behavioral: myofunctional therapy |
| Control | No intervention | Standard twin block therapy will be used for Class II patients. Patients will be informed that they are involved in a study that follows growth and development, and they will receive feedback on whether they use their devices properly, but no myofunctional exercise. |
What is being measured
The primary outcome is the main question the study is designed to answer.
SNB Angle (sella-nasion-point B Angle at cephalometric analysis)
Cephalometric analysis can be performed to evaluate the cranial base, the relationship of the maxilla to the cranial base, the mandible's size and position relative to the cranial base, the relationship between the maxilla and the mandible, the vertical dimension, maxillary and mandibular dentition, and soft tissue. The angle between the sella/nasion plane and nasion/B plane (normal value at the end of growth 80 ± 2°). This angle assesses the antero-posterior position of the mandible relative to the upper cranial structures. SNB indicates whether or not the mandible is normal, prognathic, or retrognathic.
Measured: 6 months
SNA Angle (sella-nasion-point A Angle at cephalometric analysis)
Cephalometric analysis can be performed to evaluate the cranial base, the relationship of the maxilla to the cranial base, the mandible's size and position relative to the cranial base, the relationship between the maxilla and the mandible, the vertical dimension, maxillary and mandibular dentition, and soft tissue. SNA is the the angle between the sella/nasion plane and the nasion/A plane (normal value at the end of growth 82 ± 2°). This angle assesses the antero-posterior position of the maxilla relative to the upper cranial structures. It indicates whether or not the maxilla is normal, prognathic, or retrognathic.
Measured: 12 months
ANB Angle (point A-nasion-point B Angle at cephalometric analysis)
The difference between SNA and SNB angles
Measured: 12 months
PASmin mm (PAS min = The shortest distance between base of the tongue and the posterior wall of the pharynx at cephalometric analysis)
The minimal distance between the base of the tongue and the posterior pharyngeal wall, representing the minimal pharyngeal airway space
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2022
- Study start18 Oct 2021
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malocclusion, Angle Class IIStudies 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
- Double blinded controlled clinical study
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Sponsor
- Investigators
- Banu Kılıç, asst. prof, Study director, Bezmialem Vakıf Üniversitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05227469
- Sponsor's protocol ID
- BezmialemVU myofunctional
- Acronym
- twin block
- Status last verified
- May 2022
- First submitted
- 12 Jan 2022
- Last updated
- 26 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Myofunctional Exercises in Class II Patients
- ClinicalTrials.gov ID
- NCT05227469
- Acronym / sponsor ID
- twin block / BezmialemVU myofunctional
- Conditions
- Malocclusion, Angle Class II
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 18 Oct 2021 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 7 Feb 2022 (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.
There are situations where orthodontic treatment cannot provide long-term benefits. The proposed orthotropic theory proposes that environmental factors cause malocclusion and genes decide its pattern. The primary aim of this project is to increase the success, aesthetics and permanence of the treatment result by providing the best facial change of the pediatric patients in the MP3cap period, and that myofunctional exercises can be used in addition to orthodontic treatments during the treatment process of the patients.
Detailed description
Many studies in recent years have emphasized the importance of the environmental factor as well as the hereditary causes of malocclusion. In particular, the activity and posture of the oral soft tissues have begun to be mentioned more. In the presence of bad habits, there are cases where orthodontic treatment alone is not sufficient and must be combined with myofunctional treatments. There are also many physicians who emphasize the importance of positioning the tongue in contact with the palate during swallowing and resting.
It is known that habits during growth and development cause malocclusions that may occur in the future. It may be possible to acquire some myofunctional exercises as a habit during the growth and development period as a prophylactic solution against malocclusions. In addition to twin block treatment, myofunctional exercises will be given to class II pediatric patients in the MP3cap period, and the effect of exercises on oral soft and hard tissues will be compared at the end of the treatment. The effects of tongue and lip movements on facial development as well as on the treatment process will be examined. Perhaps in the future, everyone can recommend doing myofunctional exercises in addition to tooth brushing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double blinded controlled clinical study
| Arm | Type | Receives |
|---|---|---|
| Skeletal class II twinblock + myofunctional therapy | Experimental | Behavioral: myofunctional therapyMyofunctional exercises will be prescribed in addition to the standart twin block therapy. Movements will be taught to this group, for which we have prescribed the exercises. It will be ensured that the exercises are done more properly and regularly by taking video recordings every other day from the group that does the exercises twice a day. Incorrect exercises will be corrected by providing feedback. |
| Control | No intervention | –Standard twin block therapy will be used for Class II patients. Patients will be informed that they are involved in a study that follows growth and development, and they will receive feedback on whether they use their devices properly, but no myofunctional exercise. |
Who may qualify
- Ages
- 9 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Having a skeletal Class II relationship (ANB > 4°),
- Skeletal Class II relationship due to mandibular retrognathia (SNB < 78°),
- Overjet is more than 5 mm,
- Normal growth pattern SN-GoGn (32° ± 6°),
- Minimum crowding of the dental arch is 4 mm or less,
Key exclusion criteria (6 listed)
- Having received orthodontic treatment before,
- Having severe maxillary stenosis,
- Severe facial asymmetry according to clinical and x-ray analysis,
- Poor oral hygiene,
- Having mental retardation at a level that will affect the patient's cooperation,
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 |
|---|---|---|
| myofunctional therapyIn order to confirm that the exercises are done for a sufficient time and are done correctly, the researcher will take video recordings from the participants and examine these recordings every other day. Respondents will be contacted when errors are detected. | Behavioural | Skeletal class II twinblock + myofunctional therapy |
Primary outcome
SNB Angle (sella-nasion-point B Angle at cephalometric analysis)
Time frame: 6 months
Cephalometric analysis can be performed to evaluate the cranial base, the relationship of the maxilla to the cranial base, the mandible's size and position relative to the cranial base, the relationship between the maxilla and the mandible, the vertical dimension, maxillary and mandibular dentition, and soft tissue. The angle between the sella/nasion plane and nasion/B plane (normal value at the end of growth 80 ± 2°). This angle assesses the antero-posterior position of the mandible relative to the upper cranial structures. SNB indicates whether or not the mandible is normal, prognathic, or retrognathic.
SNA Angle (sella-nasion-point A Angle at cephalometric analysis)
Time frame: 12 months
Cephalometric analysis can be performed to evaluate the cranial base, the relationship of the maxilla to the cranial base, the mandible's size and position relative to the cranial base, the relationship between the maxilla and the mandible, the vertical dimension, maxillary and mandibular dentition, and soft tissue. SNA is the the angle between the sella/nasion plane and the nasion/A plane (normal value at the end of growth 82 ± 2°). This angle assesses the antero-posterior position of the maxilla relative to the upper cranial structures. It indicates whether or not the maxilla is normal, prognathic, or retrognathic.
ANB Angle (point A-nasion-point B Angle at cephalometric analysis)
Time frame: 12 months
The difference between SNA and SNB angles
PASmin mm (PAS min = The shortest distance between base of the tongue and the posterior wall of the pharynx at cephalometric analysis)
Time frame: 12 months
The minimal distance between the base of the tongue and the posterior pharyngeal wall, representing the minimal pharyngeal airway space
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2022.
- Individual participant dataSharing planned: No
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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.
Banu Kılıç, asst. prof study director
Bezmialem Vakıf Üniversitesi
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing myofunctional therapy in people with Malocclusion, Angle Class II, run by Bezmialem Vakif University at 2 sites in Turkey (Türkiye).
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 7 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: status not confirmed, as of the sponsor's last update on 26 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Banu Kılıç, asst. prof (+905322432756, bkilic@bezmialem.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SNB Angle (sella-nasion-point B Angle at cephalometric analysis) (time frame: 6 months). The study lists 4 primary outcomes in all. 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 26 May 2022.