Myofunctional Therapy Twin Block

NCT ID: NCT05227469

Last Updated: 2022-05-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-18

Study Completion Date

2022-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Malocclusion, Angle Class II

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double blinded controlled clinical study
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

myofunctional therapy

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

9 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The Scientific and Technological Research Council of Turkey

OTHER

Sponsor Role collaborator

Bezmialem Vakif University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Banu Kılıç, asst. prof

Role: STUDY_DIRECTOR

Bezmialem Vakıf Üniversitesi

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Banu Kilic

Istanbul, Fatih, Turkey (Türkiye)

Site Status RECRUITING

Banu Kılıç

Fatih, Istanbul, Turkey (Türkiye)

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Banu Kılıç, asst. prof

Role: CONTACT

+905322432756

Corc Şahin

Role: CONTACT

+905313614388

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Banu Kilic

Role: primary

05322432756

Banu Kılıç

Role: primary

05322432756

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BezmialemVU myofunctional

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.