Myofunctional Therapy Twin Block

Malocclusion, Angle Class II Clinical Trial

— twin block  

Official title:

The Effect of Myofunctional Exercises in Class II Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05227469
• Other study ID #: BezmialemVU myofunctional
• Status: Recruiting
• Phase: N/A
• Start date: October 18, 2021
• Est. completion date: December 1, 2022

Study information

• Verified date: May 2022
• Source: Bezmialem Vakif University
• Contact: Banu Kiliç, asst. prof
• Phone: +905322432756
• Email: bkilic[@]bezmialem.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: December 1, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Years to 15 Years

Eligibility

Inclusion Criteria:

1. Having a skeletal Class II relationship (ANB > 4°),

2. Skeletal Class II relationship due to mandibular retrognathia (SNB < 78°),

3. Overjet is more than 5 mm,

4. Normal growth pattern SN-GoGn (32° ± 6°),

5. Minimum crowding of the dental arch is 4 mm or less,

6. Bilateral Class II molar and canine relationship is at least 3.5 mm,

7. Patients who are in MP3 cap period will be taken according to the Tanner-Whitehouse wrist and wrist X-ray method.

Exclusion Criteria:

1. Having received orthodontic treatment before,

2. Having severe maxillary stenosis,

3. Severe facial asymmetry according to clinical and x-ray analysis,

4. Poor oral hygiene,

5. 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.

Related Conditions & MeSH terms

• Malocclusion
• Malocclusion, Angle Class II

Intervention

Behavioral:
• myofunctional therapy
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.

Locations

Country	Name	City	State
Turkey	Banu Kiliç	Fatih	Istanbul
Turkey	Banu Kilic	Istanbul	Fatih

Sponsors (2)

Lead Sponsor	Collaborator
Bezmialem Vakif University	The Scientific and Technological Research Council of Turkey

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months
Primary	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.	12 months
Primary	ANB Angle (point A-nasion-point B Angle at cephalometric analysis)	The difference between SNA and SNB angles	12 months
Primary	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	12 months