Maxillary Transverse DeficiencyNCT07858370
Three-Dimensional Facial Soft Tissue Changes and Clinical Perception Following MARPE
An observational study of Maxillary Transverse Deficiency, run by Adiyaman University at 1 site in Turkey (Türkiye).
Trial summary
This prospective, controlled observational study aims to evaluate three-dimensional (3D) facial soft tissue changes following miniscrew-assisted rapid palatal expansion (MARPE) and determine whether these changes are clinically perceptible to orthodontic specialists and patients. Read more about this study
- Who is it for?
- Ages 16 to 25 years
- Conditions the study is for
- Maxillary Transverse Deficiency
- What is being tested?
- Miniscrew-Assisted Rapid Palatal Expansion (MARPE)
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2026to 1 May 2028
- Phase
- Observational
- 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 16 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The study population will consist of 60 postpubertal orthodontic patients aged 16-25 years recruited from the Department of Orthodontics, Faculty of Dentistry, Adiyaman University, Türkiye. The MARPE group will include 40 patients undergoing clinically indicated maxillary expansion, while the control group will consist of 20 age- and skeletal maturation-matched orthodontic patients who will not receive maxillary expansion during the observation period. All participants will be prospectively followed using three-dimensional facial scans. Treatment decisions will be made independently of study participation.
Who may be able to join
- Individuals aged 16-25 years.
- Postpubertal skeletal maturation confirmed by cervical vertebral maturation (CVM) assessment using existing lateral cephalometric radiographs.
- Patients with a clinical indication for miniscrew-assisted rapid palatal expansion (MARPE), determined independently of the study (MARPE group).
- Orthodontic patients matched for age and skeletal maturation who will not undergo maxillary expansion during the observation period (control group).
- Willingness to participate and provision of informed consent (and parental/legal guardian consent for participants under 18 years).
Who cannot join
- History of previous maxillary expansion treatment.
- Previous or planned orthognathic surgery during the observation period.
- Facial aesthetic procedures or surgical interventions that may influence soft tissue morphology during follow-up.
- Systemic diseases or craniofacial conditions affecting bone or soft tissue development.
- Maxillary expansion performed in control participants during the observation period.
- Inability to complete the required facial scans or follow-up assessments.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Adiyaman University Faculty of Dentistry, Department of Orthodontics
Adıyaman, Adıyaman Province, 02040
Hasan Kılınç, research assistant, +90 416 219 72 80, hkilinc@adiyaman.edu.tr
About this study
Official title: Evaluation of Three-Dimensional Facial Soft Tissue Changes and Their Clinical Perceptibility Following Miniscrew-Assisted Rapid Palatal Expansion (MARPE)
This prospective, controlled observational study aims to evaluate three-dimensional (3D) facial soft tissue changes following miniscrew-assisted rapid palatal expansion (MARPE) and determine whether these changes are clinically perceptible to orthodontic specialists and patients.
A total of 55 postpubertal participants aged 16-25 years will be included: 40 patients undergoing MARPE as part of their routine orthodontic treatment and 15 control participants who will not undergo maxillary expansion. Treatment decisions will be made independently of study participation.
Read more
Facial soft tissue changes will be assessed using 3D facial scans. The MARPE group will be scanned before expansion (T0), immediately after active expansion (T1), and three months after expansion (T2). The control group will undergo two facial scans at comparable baseline and follow-up intervals.
Changes in facial regions, including the nose, paranasal area, midface, and upper lip, will be evaluated. Blinded orthodontic specialists will assess the clinical perceptibility of changes using standardized facial images, while participants will provide their own perception of facial changes through questionnaires. When available from routine clinical records, skeletal and dental expansion measurements will also be analyzed in relation to the observed soft tissue changes.
The study aims to clarify the magnitude, distribution, and clinical relevance of facial soft tissue changes associated with MARPE.
Read the detailed description
his single-center prospective controlled observational study will investigate facial soft tissue changes associated with miniscrew-assisted rapid palatal expansion (MARPE) in postpubertal individuals.
Three-dimensional facial images will be obtained using the MetiSmile facial scanning system (Shining 3D, Hangzhou, China) under standardized conditions, including natural head position, neutral facial expression, and relaxed lips.
The MARPE group will be evaluated at three time points: before appliance activation (T0), following completion of active expansion (T1), and after a three-month retention period (T2). The control group will undergo facial scanning at baseline and at a follow-up interval corresponding to the T0-T2 observation period.
Regional soft tissue changes will be assessed in the nasal, alar base, paranasal, nasolabial, midfacial, and upper lip regions. Clinical perceptibility will be investigated through blinded orthodontic specialist assessments of standardized facial image pairs. Patient-reported perception of facial changes will also be recorded using structured questionnaires.
Where routine clinical CBCT records are available, skeletal expansion and intermolar width changes will be measured and their relationships with regional facial soft tissue changes will be investigated. No additional radiographic examinations will be performed solely for research purposes.
Comparisons between the MARPE and control groups will be used to distinguish expansion-associated facial changes from changes occurring during the observation period.
- Conditions
- Maxillary Transverse Deficiency
- Being tested
- Miniscrew-Assisted Rapid Palatal Expansion (MARPE)
- Keywords
- Miniscrew-Assisted Rapid Palatal Expansion (MARPE), Three-Dimensional Facial Scanning, Facial Soft Tissue Changes, Clinical Perceptibility, Patient-Reported Perception, Orthodontics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Miniscrew-Assisted Rapid Palatal Expansion (MARPE)Device
MARPE is performed as part of routine orthodontic treatment based on an independent clinical indication. The study does not assign or modify the treatment. Three-dimensional facial scans are obtained before expansion (T0), immediately after active expansion (T1), and at the third month of retention (T2) to evaluate facial soft tissue changes.
| Study group | Role | What they receive |
|---|---|---|
| MARPE Group | Participants aged 16-25 years with a clinical indication for miniscrew-assisted rapid palatal expansion (MARPE). A total of 40 participants will undergo routine MARPE treatment independently of the study. Three-dimensional facial scans will be obtained before expansion (T0), immediately after active expansion (T1), and at the third month of retention (T2). Receives: Device: Miniscrew-Assisted Rapid Palatal Expansion (MARPE) | |
| Control Group | Twenty age- and skeletal maturation-matched orthodontic patients who will not undergo maxillary expansion during the observation period. Routine orthodontic treatment may continue. Three-dimensional facial scans will be obtained at two time points corresponding to the baseline and three-month retention follow-up interval of the MARPE group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Three-Dimensional Facial Soft Tissue Changes Following MARPE
Three-dimensional facial soft tissue changes will be evaluated using MetiSmile facial scans. Regional changes in the nasal, paranasal, midfacial, zygomatic, and upper lip areas will be quantified in millimeters (mm) by comparing baseline and follow-up scans. Changes from T0 to T2 will be compared between the MARPE and control groups. Additional changes between T0-T1 and T1-T2 will be assessed in the MARPE group.
Measured: Baseline (T0), immediately after active expansion (T1), and 3 months after active expansion (T2). Control participants will be assessed at two corresponding time points.
Secondary outcomes (1)
Expert Assessment of Perceived Facial Changes
Blinded orthodontic experts will evaluate paired three-dimensional facial images to assess the perceptibility and magnitude of facial changes. Assessments will include identification of the later time point, confidence level (0-10), perceived change severity (0-4), and facial regions showing the most noticeable changes.
Measured: Baseline (T0) to 3 months after active expansion (T2).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 May 2028 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Adiyaman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hasan KILINÇ, Adiyaman University
- Investigators
- Nihal HAMAMCI, Professor Doctor, Principal investigator, Adiyaman UniversityHasan Kılınç, research assistant, Study director, Adiyaman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07858370
- Sponsor's protocol ID
- ADIYAMAN-MARPE-2026-01
- Status last verified
- Oct 2026
- First submitted
- 29 Sep 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Three-Dimensional Facial Soft Tissue Changes and Their Clinical Perceptibility Following Miniscrew-Assisted Rapid Palatal Expansion (MARPE)
- ClinicalTrials.gov ID
- NCT07858370
- Acronym / sponsor ID
- ADIYAMAN-MARPE-2026-01
- Conditions
- Maxillary Transverse Deficiency
- Keywords
- Miniscrew-Assisted Rapid Palatal Expansion (MARPE), Three-Dimensional Facial Scanning, Facial Soft Tissue Changes, Clinical Perceptibility, Patient-Reported Perception, Orthodontics
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Adiyaman UniversityUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 May 2028 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 5 Oct 2026 (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 prospective, controlled observational study aims to evaluate three-dimensional (3D) facial soft tissue changes following miniscrew-assisted rapid palatal expansion (MARPE) and determine whether these changes are clinically perceptible to orthodontic specialists and patients.
A total of 55 postpubertal participants aged 16-25 years will be included: 40 patients undergoing MARPE as part of their routine orthodontic treatment and 15 control participants who will not undergo maxillary expansion. Treatment decisions will be made independently of study participation.
Facial soft tissue changes will be assessed using 3D facial scans. The MARPE group will be scanned before expansion (T0), immediately after active expansion (T1), and three months after expansion (T2). The control group will undergo two facial scans at comparable baseline and follow-up intervals.
Changes in facial regions, including the nose, paranasal area, midface, and upper lip, will be evaluated. Blinded orthodontic specialists will assess the clinical perceptibility of changes using standardized facial images, while participants will provide their own perception of facial changes through questionnaires. When available from routine clinical records, skeletal and dental expansion measurements will also be analyzed in relation to the observed soft tissue changes.
The study aims to clarify the magnitude, distribution, and clinical relevance of facial soft tissue changes associated with MARPE.
Detailed description
his single-center prospective controlled observational study will investigate facial soft tissue changes associated with miniscrew-assisted rapid palatal expansion (MARPE) in postpubertal individuals.
Three-dimensional facial images will be obtained using the MetiSmile facial scanning system (Shining 3D, Hangzhou, China) under standardized conditions, including natural head position, neutral facial expression, and relaxed lips.
The MARPE group will be evaluated at three time points: before appliance activation (T0), following completion of active expansion (T1), and after a three-month retention period (T2). The control group will undergo facial scanning at baseline and at a follow-up interval corresponding to the T0-T2 observation period.
Regional soft tissue changes will be assessed in the nasal, alar base, paranasal, nasolabial, midfacial, and upper lip regions. Clinical perceptibility will be investigated through blinded orthodontic specialist assessments of standardized facial image pairs. Patient-reported perception of facial changes will also be recorded using structured questionnaires.
Where routine clinical CBCT records are available, skeletal expansion and intermolar width changes will be measured and their relationships with regional facial soft tissue changes will be investigated. No additional radiographic examinations will be performed solely for research purposes.
Comparisons between the MARPE and control groups will be used to distinguish expansion-associated facial changes from changes occurring during the observation period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MARPE Group | – | Device: Miniscrew-Assisted Rapid Palatal Expansion (MARPE)Participants aged 16-25 years with a clinical indication for miniscrew-assisted rapid palatal expansion (MARPE). A total of 40 participants will undergo routine MARPE treatment independently of the study. Three-dimensional facial scans will be obtained before expansion (T0), immediately after active expansion (T1), and at the third month of retention (T2). |
| Control Group | – | –Twenty age- and skeletal maturation-matched orthodontic patients who will not undergo maxillary expansion during the observation period. Routine orthodontic treatment may continue. Three-dimensional facial scans will be obtained at two time points corresponding to the baseline and three-month retention follow-up interval of the MARPE group. |
Who may qualify
- Ages
- 16 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The study population will consist of 60 postpubertal orthodontic patients aged 16-25 years recruited from the Department of Orthodontics, Faculty of Dentistry, Adiyaman University, Türkiye. The MARPE group will include 40 patients undergoing clinically indicated maxillary expansion, while the control group will consist of 20 age- and skeletal maturation-matched orthodontic patients who will not receive maxillary expansion during the observation period. All participants will be prospectively followed using three-dimensional facial scans. Treatment decisions will be made independently of study participation.
Key inclusion criteria (5 listed)
- Individuals aged 16-25 years.
- Postpubertal skeletal maturation confirmed by cervical vertebral maturation (CVM) assessment using existing lateral cephalometric radiographs.
- Patients with a clinical indication for miniscrew-assisted rapid palatal expansion (MARPE), determined independently of the study (MARPE group).
- Orthodontic patients matched for age and skeletal maturation who will not undergo maxillary expansion during the observation period (control group).
- Willingness to participate and provision of informed consent (and parental/legal guardian consent for participants under 18 years).
Key exclusion criteria (6 listed)
- History of previous maxillary expansion treatment.
- Previous or planned orthognathic surgery during the observation period.
- Facial aesthetic procedures or surgical interventions that may influence soft tissue morphology during follow-up.
- Systemic diseases or craniofacial conditions affecting bone or soft tissue development.
- Maxillary expansion performed in control participants during the observation period.
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 |
|---|---|---|
| Miniscrew-Assisted Rapid Palatal Expansion (MARPE)MARPE is performed as part of routine orthodontic treatment based on an independent clinical indication. The study does not assign or modify the treatment. Three-dimensional facial scans are obtained before expansion (T0), immediately after active expansion (T1), and at the third month of retention (T2) to evaluate facial soft tissue changes. | Device | MARPE Group |
Primary outcome
Three-Dimensional Facial Soft Tissue Changes Following MARPE
Time frame: Baseline (T0), immediately after active expansion (T1), and 3 months after active expansion (T2). Control participants will be assessed at two corresponding time points.
Three-dimensional facial soft tissue changes will be evaluated using MetiSmile facial scans. Regional changes in the nasal, paranasal, midfacial, zygomatic, and upper lip areas will be quantified in millimeters (mm) by comparing baseline and follow-up scans. Changes from T0 to T2 will be compared between the MARPE and control groups. Additional changes between T0-T1 and T1-T2 will be assessed in the MARPE group.
1 secondary outcome
Expert Assessment of Perceived Facial Changes
Time frame: Baseline (T0) to 3 months after active expansion (T2).
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 6 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Nihal HAMAMCI, Professor Doctor principal investigator
Adiyaman University
Hasan Kılınç, research assistant study director
Adiyaman University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Maxillary Transverse Deficiency, run by Adiyaman University 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 6 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: opening soon, as of the sponsor's last update on 6 Oct 2026. 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?
Contact Hasan Kılınç, research assistant (+90 416 219 72 80, hkilinc@adiyaman.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Three-Dimensional Facial Soft Tissue Changes Following MARPE (time frame: Baseline (T0), immediately after active expansion (T1), and 3 months after active expansion (T2). Control participants will be assessed at two corresponding time points.). 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 6 Oct 2026.