Myofunctional Therapy Twin Block

NCT05227469 | Unknown DMC

• 1 other identifier: BezmialemVU myofunctional
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Malocclusion, Angle Class II

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

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.

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.

Interventions

myofunctional therapy BEHAVIORAL

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.

Skeletal class II twinblock + myofunctional therapy

Eligibility Criteria

• Age: 9 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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,
• \. Having a systemic disease that will affect the orthodontic treatment, 8. Congenital anomaly or syndrome.

Sponsors & Collaborators

• Bezmialem Vakif University: lead
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (2)

Banu Kilic

Istanbul, Fatih, 34844, Turkey (Türkiye)

RECRUITING

Banu Kılıç

Fatih, Istanbul, 34093, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Malocclusion, Angle Class II

Interventions

Myofunctional Therapy

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation of Speech and Language Disorders; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Dentistry

Study Officials

• Banu Kılıç, asst. prof

  Bezmialem Vakıf Üniversitesi

  STUDY DIRECTOR

Central Study Contacts

Banu Kılıç, asst. prof

CONTACT

+905322432756; bkilic@bezmialem.edu.tr

Corc Şahin

CONTACT

+905313614388; corc.lukas.sahin@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Only the care provider will know which patients had only twin block treatment and which patients had both twin block and egzersize treatment. Control group will have unrevealant egzercises or no egzercises.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double blinded controlled clinical study

Study Record Dates

• First Submitted: January 12, 2022
• First Posted: February 7, 2022
• Study Start: October 18, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: May 26, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)