Maxillary Transverse DeficiencyNCT07150572
Evaluation of the Effect of Surgically Assisted Rapid Maxillary Expansion on Tooth Color
A study testing surgery assisted rapid maxillary expansion in people with Maxillary Transverse Deficiency, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
This prospective study aimed to evaluate effects of surgically assisted rapid maxillary expansion (SARME) on the color, maxillary anterior teeth by comparing them with untreated control group. Read more about this study
- Who is it for?
- Ages 16 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Maxillary Transverse Deficiency
- What is being tested?
- surgery assisted rapid maxillary expansion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Aug 2023to 1 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Young adult patients with completed growth and development,
- Presence of maxillary transverse deficiency greater than 5 mm,
- Patients with bilateral or unilateral posterior crossbite,
- Absence of congenital tooth loss, fractures, restorative procedures, or root canal treatment in the maxillary arch,
- Good patient cooperation.
- Young adult patients with no history of orthodontic treatment,
- Absence of congenital tooth loss, fractures, restorative procedures, or root canal treatment in the maxillary anterior teeth.
- -
Who cannot join
- Patients consuming more than two cups of coffee or tea per day,
- Patients who smoke,
- Presence of systemic disorders that interfere with surgical procedures or bone metabolism,
- Patients with craniofacial deformities or syndromic conditions,
- Patients with poor cooperation.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bezmialem Vakif University
Istanbul, Fatih, 34093
About this study
This prospective study aimed to evaluate effects of surgically assisted rapid maxillary expansion (SARME) on the color, maxillary anterior teeth by comparing them with untreated control group.
Read the detailed description
In this study fifteen patients who underwent SARME and fifteen untreated control patients were included. Color measurements of the six maxillary anterior teeth were performed using a spectrophotometer. Periodontal health was assessed using the Gingival Index(GI), Probing Depth(PD), Plaque Index(PI), while pulp sensitivity was evaluated using an electric pulp tester(EPT). Color changes were calculated and fractal analysis was performed on CBCT images obtained evaluate the trabecular bone structure adjacent to the maxillary central incisors.
- Conditions
- Maxillary Transverse Deficiency
- Being tested
- surgery assisted rapid maxillary expansion
- Keywords
- maxillary transverse deficiency, surgery asssisted rapid maxillary expansion, tooth color
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgery assisted rapid maxillary expansionProcedure or surgery
Under general anesthesia, the patients underwent a maxillary expansion procedure, during which the maxillary resistance sites were surgically released
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | Under general anesthesia, the patients underwent a maxillary expansion procedure, during which the maxillary resistance sites were surgically released Receives: Procedure: surgery assisted rapid maxillary expansion |
| control group | No intervention | no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tooth color parameters
In this study patient who underwent SARME and untreated control groups teeth color were measured with spectrophotometer.
Measured: 17 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2025
- Study start10 Aug 2023
- Primary completion25 Jul 2025
- Study completion1 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Maxillary Transverse DeficiencyStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ezgi Sunal Akturk, Assistant Professor, Study chair, Saglik Bilimleri UniversitesiGokmen Kurt, Professor, Study chair, Bezmialem Vakif UniversityFatma Derin Alpaydin, Research Assistant, Principal investigator, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07150572
- Sponsor's protocol ID
- 118115
- Status last verified
- Aug 2025
- First submitted
- 25 Aug 2025
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Derin Alpaydin F, Sunal Akturk E, Kurt G, Dolanmaz D, Pergel T. Effects of surgically assisted rapid maxillary expansion on the anterior maxillary teeth and trabecular bone structure: a controlled clinical study. Clin Oral Investig. 2026 Sep 4;30(9):432. doi: 10.1007/s00784-026-07096-z.
PubMed 42696212
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 Surgically Assisted Rapid Maxillary Expansion on Tooth Color
- ClinicalTrials.gov ID
- NCT07150572
- Acronym / sponsor ID
- 118115
- Conditions
- Maxillary Transverse Deficiency
- Keywords
- maxillary transverse deficiency, surgery asssisted rapid maxillary expansion, tooth color
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 10 Aug 2023 (actual)
- Primary completion
- 25 Jul 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 2 Sep 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 prospective study aimed to evaluate effects of surgically assisted rapid maxillary expansion (SARME) on the color, maxillary anterior teeth by comparing them with untreated control group.
Detailed description
In this study fifteen patients who underwent SARME and fifteen untreated control patients were included. Color measurements of the six maxillary anterior teeth were performed using a spectrophotometer. Periodontal health was assessed using the Gingival Index(GI), Probing Depth(PD), Plaque Index(PI), while pulp sensitivity was evaluated using an electric pulp tester(EPT). Color changes were calculated and fractal analysis was performed on CBCT images obtained evaluate the trabecular bone structure adjacent to the maxillary central incisors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Procedure: surgery assisted rapid maxillary expansionUnder general anesthesia, the patients underwent a maxillary expansion procedure, during which the maxillary resistance sites were surgically released |
| control group | No intervention | –no intervention |
Who may qualify
- Ages
- 16 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Young adult patients with completed growth and development,
- Presence of maxillary transverse deficiency greater than 5 mm,
- Patients with bilateral or unilateral posterior crossbite,
- Absence of congenital tooth loss, fractures, restorative procedures, or root canal treatment in the maxillary arch,
- Good patient cooperation.
Key exclusion criteria (5 listed)
- Patients consuming more than two cups of coffee or tea per day,
- Patients who smoke,
- Presence of systemic disorders that interfere with surgical procedures or bone metabolism,
- Patients with craniofacial deformities or syndromic conditions,
- Patients with poor cooperation.
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 |
|---|---|---|
| surgery assisted rapid maxillary expansionUnder general anesthesia, the patients underwent a maxillary expansion procedure, during which the maxillary resistance sites were surgically released | Procedure or surgery | Study Group |
Primary outcome
Tooth color parameters
Time frame: 17 months
In this study patient who underwent SARME and untreated control groups teeth color were measured with spectrophotometer.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- Derived from this study: PubMed 42696212Derin Alpaydin F, Sunal Akturk E, Kurt G, Dolanmaz D, Pergel T. Effects of surgically assisted rapid maxillary expansion on the anterior maxillary teeth and trabecular bone structure: a controlled clinical study. Clin Oral Investig. 2026 Sep 4;30(9):432. doi: 10.1007/s00784-026-07096-z.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Ezgi Sunal Akturk, Assistant Professor study chair
Saglik Bilimleri Universitesi
Gokmen Kurt, Professor study chair
Bezmialem Vakif University
Fatma Derin Alpaydin, Research Assistant principal investigator
Bezmialem Vakif University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing surgery assisted rapid maxillary expansion in people with Maxillary Transverse Deficiency, run by Bezmialem Vakif 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 8 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: finished, 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Tooth color parameters (time frame: 17 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07150572, which also lists 1 linked publication.
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.