Evaluation of the Effect of MARPE on Speech

NCT06981507 | Active Not Recruiting

• 1 other identifier: 2025536
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigates the effects of Miniscrew-Assisted Rapid Palatal Expansion (MARPE) on speech characteristics in adolescent and young adult patients. While MARPE is a widely used orthodontic procedure for treating maxillary transverse deficiency, its potential impact on speech production has not been thoroughly evaluated. The aim of this study is to assess whether MARPE treatment causes any temporary or long-term changes in speech patterns using acoustic and perceptual analysis methods.

Conditions

Evaluation of Speech Characteristics Following MARPE Treatment in Patients With Maxillary Transverse Deficiency

Keywords

MARPE, Palatal Expansion, Orthodontics, Speech, Acoustic Analysis, Maxillary Transverse Deficiency

Outcome Measures

Primary Outcomes (1)

• Speech Changes After MARPE Treatment

  Baseline and 1 month after expansion

Study Arms (1)

MARPE Intervention Group

EXPERIMENTAL

Device: MARPE (Miniscrew-Assisted Rapid Palatal Expansion)

Interventions

MARPE (Miniscrew-Assisted Rapid Palatal Expansion) DEVICE

MARPE (Miniscrew-Assisted Rapid Palatal Expansion) is an orthodontic expansion technique that uses a palatal expander anchored with miniscrews inserted into the palatal bone. The device applies lateral force to widen the maxilla skeletally in patients with transverse maxillary deficiency. In this study, all participants will receive MARPE treatment as part of their orthodontic management, and its potential effects on speech will be evaluated over time.

MARPE Intervention Group

Eligibility Criteria

• Age: 15 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients with Class I malocclusion
• Presence of maxillary transverse deficiency
• Young adult patients aged 15 to 18 years
• No history of systemic disease, cleft lip/palate, or speech disorders
• No history of previous orthodontic treatment

You may not qualify if:

• Patients with any systemic disease
• Patients who smoke
• Patients with poor oral hygiene
• Patients with cooperation difficulties
• Patients with mental retardation or cognitive impairment

Sponsors & Collaborators

• Konya Necmettin Erbakan Üniversitesi: lead

Study Sites (1)

Necmettin Erbakan University, Faculty of Dentistry

Konya, Meram, 42080, Turkey (Türkiye)

Location

Related Links

• Related Info

MeSH Terms

Conditions

Speech

Condition Hierarchy (Ancestors)

Verbal Behavior; Communication; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: May 1, 2025
• First Posted: May 20, 2025
• Study Start: February 10, 2025
• Primary Completion: July 10, 2025
• Study Completion: August 20, 2025
• Last Updated: September 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data and supporting documents (Study Protocol and Statistical Analysis Plan) will be available beginning 6 months after the publication of study results and will remain accessible for 3 years.
• Access Criteria: Access to de-identified individual participant data and supporting documents will be granted to qualified researchers upon reasonable request. Requestors must provide a methodologically sound proposal and sign a data use agreement. Data will be shared via secure institutional channels following approval by the principal investigator.

Locations

TU (1)