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Myofunctional Therapy Twin Block (twin block)

Primary Purpose

Malocclusion, Angle Class II

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
myofunctional therapy
Sponsored by
Bezmialem Vakif University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malocclusion, Angle Class II

Eligibility Criteria

9 Years - 15 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Banu KilicRecruiting
  • Banu KılıçRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Skeletal class II twinblock + myofunctional therapy

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
ANB Angle (point A-nasion-point B Angle at cephalometric analysis)
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)
The minimal distance between the base of the tongue and the posterior pharyngeal wall, representing the minimal pharyngeal airway space

Secondary Outcome Measures

Full Information

First Posted
January 12, 2022
Last Updated
May 20, 2022
Sponsor
Bezmialem Vakif University
Collaborators
The Scientific and Technological Research Council of Turkey
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1. Study Identification

Unique Protocol Identification Number
NCT05227469
Brief Title
Myofunctional Therapy Twin Block
Acronym
twin block
Official Title
The Effect of Myofunctional Exercises in Class II Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 18, 2021 (Actual)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bezmialem Vakif University
Collaborators
The Scientific and Technological Research Council of Turkey

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malocclusion, Angle Class II

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Double blinded controlled clinical study
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Skeletal class II twinblock + myofunctional therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
myofunctional therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
SNB Angle (sella-nasion-point B Angle at cephalometric analysis)
Description
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.
Time Frame
6 months
Title
SNA Angle (sella-nasion-point A Angle at cephalometric analysis)
Description
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.
Time Frame
12 months
Title
ANB Angle (point A-nasion-point B Angle at cephalometric analysis)
Description
The difference between SNA and SNB angles
Time Frame
12 months
Title
PASmin mm (PAS min = The shortest distance between base of the tongue and the posterior wall of the pharynx at cephalometric analysis)
Description
The minimal distance between the base of the tongue and the posterior pharyngeal wall, representing the minimal pharyngeal airway space
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Banu Kılıç, asst. prof
Phone
+905322432756
Email
bkilic@bezmialem.edu.tr
First Name & Middle Initial & Last Name or Official Title & Degree
Corc Şahin
Phone
+905313614388
Email
corc.lukas.sahin@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Banu Kılıç, asst. prof
Organizational Affiliation
Bezmialem Vakıf Üniversitesi
Official's Role
Study Director
Facility Information:
Facility Name
Banu Kilic
City
Istanbul
State/Province
Fatih
ZIP/Postal Code
34844
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Banu Kilic
Phone
05322432756
Email
bkilic@bezmialem.edu.tr
Facility Name
Banu Kılıç
City
Fatih
State/Province
İstanbul
ZIP/Postal Code
34093
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Banu Kılıç
Phone
05322432756
Email
bkilic@bezmialem.edu.tr

12. IPD Sharing Statement

Plan to Share IPD
No

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Myofunctional Therapy Twin Block

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