Orofacial Muscle Pressure and Maxillary Transverse Development

NCT07552441 | Recruiting

• 1 other identifier: YYU-Orthodontics-2021-03
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Study Title: Investigation of the Effects of Tongue, Lip, and Cheek Pressures on the Development of Upper Jaw Narrowness Introduction and Hypothesis The structure of our face and the alignment of our teeth are influenced not only by our genetics but also by the surrounding soft tissues, such as the lips, cheeks, and tongue. These muscles exert constant pressure on our teeth and jawbones. According to the "Equilibrium Theory," teeth stay in their proper positions when the inward pressure from the lips and cheeks is balanced by the outward pressure from the tongue. The hypothesis of this study is that individuals with a narrow upper jaw (maxillary constriction) may have different muscle pressure patterns compared to those with normal jaw widths. We believe that identifying these pressure differences will help dentists and orthodontists better understand why jaw narrowness occurs and how to achieve more stable results after treatment. What is Being Measured? To measure these delicate pressures, we use a specialized, high-tech device called the Iowa Oral Performance Instrument (IOPI). This device uses a small, air-filled balloon (bulb) that the patient presses with their tongue or lips. It allows us to measure muscle strength and endurance in "kilopascals" (a unit of pressure) without any pain or discomfort. Study Procedure This study will involve patients aged 12 to 25 who are seeking orthodontic treatment at Van Yüzüncü Yıl University. We will divide the participants into two groups: Patients with a narrow upper jaw. Patients with a normal upper jaw width (the control group). Before any orthodontic braces are applied, we will measure: Tongue Pressure: How hard the tongue can push against the roof of the mouth. Lip Pressure: The strength of the upper and lower lips. Cheek (Buccal) Pressure: The pressure exerted by the cheeks during rest and function. Importance of the Study While many studies have looked at how these muscles affect the forward or backward position of teeth, there is very little research on how they affect the width of the jaw. By comparing these two groups, we hope to discover whether "weak" or "overactive" muscles contribute to a narrow palate. This information could lead to new treatment methods that focus not just on moving teeth, but also on training the oral muscles to ensure that the beautiful smiles created by orthodontists last a lifetime.

Conditions

Maxillary Transversal Deficiency (Maxillary Constriction) and Perioral Muscle Pressures (Tongue, Lip, and Cheek)

Keywords

Maxillary transversal deficiency; Perioral muscle pressure; Tongue and lip strength; Iowa Oral Performance Instrument (IOPI)

Outcome Measures

Primary Outcomes (1)

• Maximum Voluntary Tongue Pressure

  The maximum isometric pressure exerted by the tongue against the hard palate, measured in kilopascals (kPa) using the Iowa Oral Performance Instrument (IOPI). This value represents the peak functional strength of the tongue.

  Baseline (A single measurement taken prior to the initiation of any orthodontic treatment).

Secondary Outcomes (1)

• Maximum Perioral Lip Pressures (Upper and Lower)

  Baseline.

Study Arms (2)

Maxillary Constriction Group

EXPERIMENTAL

This arm includes skeletal Class I patients (aged 12-25) diagnosed with maxillary transversal constriction. Participants in this group will undergo perioral muscle pressure measurements (tongue, lip, and cheek pressures) using the Iowa Oral Performance Instrument (IOPI) in kilopascals (kPa) before the initiation of any orthodontic treatment.

Diagnostic Test: Orolingual Manometry using IOPI Pro Deluxe Kit

Control Group (Normal Maxillary Width)

EXPERIMENTAL

This arm includes skeletal Class I patients (aged 12-25) with normal maxillary transversal width. This group serves as the baseline for healthy perioral muscle function. Participants will undergo the same standardized pressure measurement protocol using the IOPI device to provide comparative data for the experimental group.

Diagnostic Test: Orolingual Manometry using IOPI Pro Deluxe Kit

Interventions

Orolingual Manometry using IOPI Pro Deluxe Kit DIAGNOSTIC_TEST

A standardized measurement of perioral muscle pressures (tongue, lip, and cheek) will be conducted using the Iowa Oral Performance Instrument (IOPI). The procedure involves placing a disposable, air-filled bulb at specific intraoral locations (e.g., retro-incisal for tongue pressure, buccal vestibule for cheek pressure). Participants are instructed to exert their maximum isometric force against the bulb for a specific duration. Each measurement is performed three times with 30-second rest intervals, and the peak pressure is recorded in kilopascals (kPa). This procedure is purely diagnostic and non-invasive, performed once for each participant before the initiation of any orthodontic intervention.

Control Group (Normal Maxillary Width); Maxillary Constriction Group

Eligibility Criteria

• Age: 12 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may not qualify if:

• History of craniofacial anomalies or syndromes (e.g., cleft lip and palate).
• Neuromuscular disorders or systemic diseases affecting muscle function.
• History of trauma to the jaw or facial region.
• Congenitally missing teeth (hypodontia) or extensive prosthetic restorations.
• Macroglossia or severe tongue-tie (ankyloglossia).
• Use of medications that may influence muscle tone (e.g., muscle relaxants).
• Presence of large tonsils or adenoids that significantly obstruct the airway.

Sponsors & Collaborators

• Yuzuncu Yil University: lead

Study Sites (1)

Van Yüzüncü Yıl University, Faculty of Dentistry, Department of Orthodontics

Van, Van, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• Kucukkeles N, Ceylanoglu C. Changes in lip, cheek, and tongue pressures after rapid maxillary expansion using a diaphragm pressure transducer. Angle Orthod. 2003 Dec;73(6):662-8. doi: 10.1043/0003-3219(2003)0732.0.CO;2.

  PMID: 14719730 RESULT

• Ozbek MM, Memikoglu UT, Altug-Atac AT, Lowe AA. Stability of maxillary expansion and tongue posture. Angle Orthod. 2009 Mar;79(2):214-20. doi: 10.2319/010908-12.1.

  PMID: 19216585 RESULT

• Adams V, Mathisen B, Baines S, Lazarus C, Callister R. A systematic review and meta-analysis of measurements of tongue and hand strength and endurance using the Iowa Oral Performance Instrument (IOPI). Dysphagia. 2013 Sep;28(3):350-69. doi: 10.1007/s00455-013-9451-3. Epub 2013 Mar 7.

  PMID: 23468283 RESULT

Related Links

• Official website of the Iowa Oral Performance Instrument (IOPI) used for orofacial muscle pressure measurements in this study
• Institution where the study is conducted - Department of Orthodontics, Van Yuzuncu Yil University Faculty of Dentistry

MeSH Terms

Conditions

Lymphoid Interstitial Pneumonia

Central Study Contacts

Saadet Çınarsoy Ciğerim, assoc prof

CONTACT

+905054870692; saadetcinarsoy@live.com

Gönül Dinç, assist prof

CONTACT

+905063094630; gonuldinc@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Not applicable. This is an open-label study where both the investigator and the participants are aware of the group assignments due to the nature of the anatomical conditions being studied. However, data analysis will be conducted using anonymized patient codes to ensure objective statistical evaluation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assist prof

Model Details: This study follows a parallel-group observational design to compare perioral muscle pressures between two distinct groups of skeletal Class I patients. Participants are allocated into one of two groups based on their clinical and radiographic diagnosis: (1) the Experimental Group, consisting of patients with maxillary transversal constriction, and (2) the Control Group, consisting of patients with normal maxillary width. Both groups undergo identical measurement protocols using the Iowa Oral Performance Instrument (IOPI) to quantify maximum and functional pressures of the tongue, lips, and cheeks (in kPa) before the initiation of orthodontic treatment. The primary comparison focuses on identifying significant differences in muscle pressure patterns between these two parallel arms to evaluate the soft tissue etiology of maxillary constriction

Study Record Dates

• First Submitted: April 20, 2026
• First Posted: April 27, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will be available beginning 6 months and ending 36 months following article publication
• Access Criteria: Data requests should be submitted to the corresponding author's institutional email. Requests will be evaluated by the principal investigator and the ethics committee of the hosting university. To gain access, data requestors will need to sign a formal data access agreement to ensure ethical usage and protect participant confidentiality.

Locations

TU (1)