Evaluation of Speech Characteristics Following MARPE Treatment in Patients With Maxillary Transverse DeficiencyMARPE-SpeechNCT06981507
Evaluation of the Effect of MARPE on Speech
A study testing MARPE (Miniscrew-Assisted Rapid Palatal Expansion) in people with Evaluation of Speech Characteristics Following MARPE Treatment in Patients With Maxillary Transverse Deficiency, run by Konya Necmettin Erbakan Üniversitesi at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 15 to 18 years
- Conditions the study is for
- Evaluation of Speech Characteristics Following MARPE Treatment in Patients With Maxillary Transverse Deficiency
- What is being tested?
- MARPE (Miniscrew-Assisted Rapid Palatal Expansion)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Feb 2025to 20 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Patients with any systemic disease
- Patients who smoke
- Patients with poor oral hygiene
- Patients with cooperation difficulties
- Patients with mental retardation or cognitive impairment
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Necmettin Erbakan University, Faculty of Dentistry
Konya, Meram, 42080
About this study
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.
Read the detailed description
This prospective clinical study aims to evaluate how Miniscrew-Assisted Rapid Palatal Expansion (MARPE) affects speech in adolescents and young adults with skeletal maxillary transverse deficiency.
Speech production relies on precise palatal anatomy and oral resonance. Since MARPE modifies the palatal structure through skeletal expansion, it may influence articulation and acoustic properties of speech. Despite its increasing use in orthodontics, the potential speech-related side effects of MARPE remain largely unexplored.
Participants aged 13-25 will undergo MARPE treatment as part of their standard orthodontic care. Speech recordings will be taken at three time points: before expansion (baseline), immediately after the active expansion phase, and after the retention period. Acoustic analysis and standardized perceptual speech evaluations will be conducted to detect any phonetic, articulatory, or resonance-related changes.
The results will help clinicians better understand the functional implications of MARPE on speech and provide guidance for counseling patients before treatment.
- Being tested
- MARPE (Miniscrew-Assisted Rapid Palatal Expansion)
- Keywords
- MARPE, Palatal Expansion, Orthodontics, Speech, Acoustic Analysis, Maxillary Transverse Deficiency
- Medical subject headings
- Speech
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| MARPE Intervention Group | Experimental | Not described Receives: Device: MARPE (Miniscrew-Assisted Rapid Palatal Expansion) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speech Changes After MARPE Treatment
Measured: Baseline and 1 month after expansion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2025
- Study start10 Feb 2025
- Primary completion10 Jul 2025
- Study completion20 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Evaluation of Speech Characteristics Following MARPE Treatment in Patients With Maxillary Transverse DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Konya Necmettin Erbakan Üniversitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, KAZIM KAAN YILDIZ, Konya Necmettin Erbakan Üniversitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06981507
- Sponsor's protocol ID
- 2025536
- Acronym
- MARPE-Speech
- Status last verified
- Aug 2025
- First submitted
- 1 May 2025
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD), including speech evaluation results and relevant demographic variables, will be shared with qualified researchers upon reasonable request. Data will be made available starting 6 months after publication of study results and will remain accessible for 3 years. Requests must be submitted via institutional email and will require a data use agreement.
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of MARPE on Speech
- ClinicalTrials.gov ID
- NCT06981507
- Acronym / sponsor ID
- MARPE-Speech / 2025536
- Keywords
- MARPE, Palatal Expansion, Orthodontics, Speech, Acoustic Analysis, Maxillary Transverse Deficiency
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Konya Necmettin Erbakan ÜniversitesiUniversity, hospital or other
- Study start
- 10 Feb 2025 (actual)
- Primary completion
- 10 Jul 2025 (actual)
- Study completion
- 20 Aug 2025 (estimated)
- First posted
- 20 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This prospective clinical study aims to evaluate how Miniscrew-Assisted Rapid Palatal Expansion (MARPE) affects speech in adolescents and young adults with skeletal maxillary transverse deficiency.
Speech production relies on precise palatal anatomy and oral resonance. Since MARPE modifies the palatal structure through skeletal expansion, it may influence articulation and acoustic properties of speech. Despite its increasing use in orthodontics, the potential speech-related side effects of MARPE remain largely unexplored.
Participants aged 13-25 will undergo MARPE treatment as part of their standard orthodontic care. Speech recordings will be taken at three time points: before expansion (baseline), immediately after the active expansion phase, and after the retention period. Acoustic analysis and standardized perceptual speech evaluations will be conducted to detect any phonetic, articulatory, or resonance-related changes.
The results will help clinicians better understand the functional implications of MARPE on speech and provide guidance for counseling patients before treatment.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MARPE Intervention Group | Experimental | Device: MARPE (Miniscrew-Assisted Rapid Palatal Expansion) |
Who may qualify
- Ages
- 15 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- Patients with any systemic disease
- Patients who smoke
- Patients with poor oral hygiene
- Patients with cooperation difficulties
- Patients with mental retardation or cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MARPE (Miniscrew-Assisted Rapid Palatal Expansion)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. | Device | MARPE Intervention Group |
Primary outcome
Speech Changes After MARPE Treatment
Time frame: Baseline and 1 month after expansion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD), including speech evaluation results and relevant demographic variables, will be shared with qualified researchers upon reasonable request. Data will be made available starting 6 months after publication of study results and will remain accessible for 3 years. Requests must be submitted via institutional email and will require a data use agreement.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MARPE (Miniscrew-Assisted Rapid Palatal Expansion) in people with Evaluation of Speech Characteristics Following MARPE Treatment in Patients With Maxillary Transverse Deficiency, run by Konya Necmettin Erbakan Üniversitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Speech Changes After MARPE Treatment (time frame: Baseline and 1 month after expansion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2025.