Myofunctional Therapy Twin Block (twin block)

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.

Study Overview

• Status: Recruiting
• Conditions: Malocclusion, Angle Class II
• Intervention / Treatment: Behavioral: myofunctional therapy

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 Type: Interventional
• Enrollment (Anticipated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Banu Kılıç, asst. prof; Phone Number: +905322432756; Email: bkilic@bezmialem.edu.tr
• Study Contact Backup: Name: Corc Şahin; Phone Number: +905313614388; Email: corc.lukas.sahin@hotmail.com

Study Locations

• Turkey
  • Fatih
    • Istanbul, Fatih, Turkey, 34844
      • Recruiting
      • Banu Kilic
      • Contact: Banu Kilic; Phone Number: 05322432756; Email: bkilic@bezmialem.edu.tr
  • İstanbul
    • Fatih, İstanbul, Turkey, 34093
      • Recruiting
      • Banu Kılıç

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 11 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Skeletal class II twinblock + myofunctional therapy; 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.	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.
No Intervention: Control; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
ANB Angle (point A-nasion-point B Angle at cephalometric analysis)	The difference between SNA and SNB angles	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	12 months

Collaborators and Investigators

• Sponsor: Bezmialem Vakif University
• Collaborators: The Scientific and Technological Research Council of Turkey

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2021
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: January 12, 2022
• First Submitted That Met QC Criteria: January 26, 2022
• First Posted (Actual): February 7, 2022

Study Record Updates

• Last Update Posted (Actual): May 26, 2022
• Last Update Submitted That Met QC Criteria: May 20, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Malocclusion; Malocclusion, Angle Class II; Overbite
• Other Study ID Numbers: BezmialemVU myofunctional

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No