Maxillary ConstrictionNCT07599202
Comparison of Laboratory-Fabricated and 3D-Printed Rapid Maxillary Expansion Appliances
A study testing Laboratory-fabricated rapid maxillary expansion appliance and 3D-printed rapid maxillary expansion appliance in people with Maxillary Constriction, run by Baskent University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to determine whether two types of rapid maxillary expansion (RME) appliances produce different outcomes in children. RME is a treatment utilized to expand a narrow upper jaw. Read more about this study
- Who is it for?
- Ages 7 to 11 years
- Conditions the study is for
- Maxillary Constriction
- What is being tested?
- Laboratory-fabricated rapid maxillary expansion appliance and 3D-printed rapid maxillary expansion appliance
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Aug 2025to Dec 2026
- 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 7 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged between 7 and 11 years
- In the mixed dentition period
- Fully erupted permanent first molars
- Presence of primary canines and primary second molars suitable for use as anchorage units for at least 6 months
- Angle Class I or Class II molar relationship
- Presence of posterior crossbite and/or moderate maxillary transverse deficiency or moderate crowding
Show all 9Show fewer
- Prepubertal growth stage corresponding to Cervical Vertebral Maturation Stage 1 (CVM1) or Stage 2 (CVM2)
- Receiving orthodontic treatment at the Başkent University Department of Orthodontics
- Parents or legal guardians willing to provide written informed consent
Who cannot join
- Previous orthodontic treatment
- Periodontal disease
- Enamel hypocalcification or significant calcium deficiency
- Root resorption
- Signs or symptoms of temporomandibular joint dysfunction
- Angle Class III molar relationship
Show all 12Show fewer
- Craniofacial syndromes
- Cleft lip and/or palate
- Known allergy to acrylic materials or metal alloys
- Inability to maintain adequate oral hygiene during treatment
- Lack of cooperation during treatment
- Repeated appliance breakage or dislodgement (three or more times)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Baskent University Faculty of Dentistry, Department of Orthodontics
Ankara, 06490
About this study
Official title: Comparison of the Skeletal and Dentoalveolar Effects and Patient Comfort of Conventional and 3D-Printed Maxillary Expansion Appliances in Mixed Dentition Patients
The goal of this clinical trial is to determine whether two types of rapid maxillary expansion (RME) appliances produce different outcomes in children. RME is a treatment utilized to expand a narrow upper jaw. This study will include children aged 8 to 10 years who need upper jaw expansion during the mixed dentition period (when they have both temporary and permanent teeth).
The main questions this study aims to answer are:
Read more
- Do 3D-printed expansion appliances produce different skeletal and dental changes compared to conventionally fabricated appliances?
- Do children feel more comfortable with one type of appliance?
- Is there a difference in pain levels or oral hygiene between the two groups?
Researchers aimed to compare a conventionally fabricated expansion appliance manufactured in a dental laboratory with a 3D-printed expansion appliance produced digitally to determine whether the method of production affects treatment outcomes and patient comfort.
Participants:
- Being treated with one of the two expansion appliances (assigned randomly)
- Follow a standard activation protocol at home with parental guidance
- Attend regular clinic visits during expansion and retention phases
- Have dental photographs, X-rays, and digital scans taken before and after treatment
- Complete an oral health-related quality of life questionnaire
- Rate their pain using a pain scale
- Have their oral hygiene measured
Read the detailed description
Treatment effectiveness, amount of expansion, and patient comfort will be evaluated between the two groups. Additionally, the impact of digital appliance production on treatment outcomes and patient satisfaction will be investigated.
This prospective, parallel-group, randomized clinical trial aims to compare the skeletal, dentoalveolar, and patient-reported effects of conventionally fabricated and three-dimensional (3D) printed rapid maxillary expansion (RME) appliances in children with transverse maxillary deficiency during the mixed dentition period.
Participants aged 8-10 years who meet the predefined inclusion criteria and require rapid maxillary expansion as part of their orthodontic treatment will be enrolled.
The results are expected to contribute evidence-based guidance for orthodontists when selecting appliance fabrication methods, balancing biological effectiveness with patient comfort and quality-of-life considerations.
Findings from this study may also support future digital workflow integration strategies in pediatric orthodontic treatment planning.
- Conditions
- Maxillary Constriction
- Being tested
- Laboratory-fabricated rapid maxillary expansion appliance, 3D-printed rapid maxillary expansion appliance
- Keywords
- Mixed dentition, 3D-printed orthodontic appliance, Digital orthodontics, Modified haas appliance, Transverse maxillary deficiency, Randomized clinical trial, Skeletal expansion, CPQ 8-10, Wong-Baker Pain Scale, Modified Silness-Löe Plaque Index, Semi-rapid maxillary expansion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laboratory-fabricated rapid maxillary expansion applianceDevice
Also called Conventional rapid maxillary expansion appliance, Modified haas-type RME appliance used in mixed dentition
A rapid maxillary expansion (RME) appliance fabricated on a dental cast obtained from conventional impressions. The expansion screw arms are adapted and soldered to orthodontic molar bands on the cast.
3D-printed rapid maxillary expansion applianceDevice
Also called Digitally fabricated modified haas-type RME appliance used in mixed dentition
A rapid maxillary expansion (RME) appliance fabricated using digital intraoral scan data. Dental models are generated from intraoral scans, and the appliance framework is manufactured as a single-piece structure using three-dimensional (3D) metal printing with sintered cobalt-chromium alloy.
| Study group | Role | What they receive |
|---|---|---|
| Laboratory-fabricated rapid maxillary expansion appliance | Experimental | Participants are treated with a laboratory-fabricated rapid maxillary expansion (RME) appliance produced on a dental cast obtained from conventional impressions. The arms of the palatal expansion screw are adapted and soldered to orthodontic molar bands on the cast model. Following adaptation, acrylic resin is added in the palatal region to increase the force distribution area. The appliance is cemented to the teeth using glass ionomer cement. Activation and retention protocols are standardized across both groups. Receives: Device: Laboratory-fabricated rapid maxillary expansion appliance |
| 3D-printed rapid maxillary expansion appliance | Experimental | Participants are treated with a rapid maxillary expansion (RME) appliance fabricated using digital intraoral scans. Dental models are generated from intraoral scan data, and the appliance framework, including the arms and tooth-supporting components, is manufactured as a single-piece structure using three-dimensional (3D) metal printing technology with sintered cobalt-chromium alloy. After fabrication, acrylic resin is added to the palatal region to increase the force distribution area. The appliance is cemented to the teeth using glass ionomer cement. Activation and retention protocols are standardized across both groups. Receives: Device: 3D-printed rapid maxillary expansion appliance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in maxillary transverse skeletal width and intermolar width from T0 to T2
The primary outcome is the difference in transverse skeletal maxillary width and maxillary intermolar width between baseline (T0) and the end of the 3-month retention period (T2). Skeletal measurements will be obtained from standardized posteroanterior cephalometric radiographs, and dental measurements will be obtained from digital model analysis.
Measured: -Preoperative (T0) -After appliance cementation (within 2 weeks) -1 week after the cementation -End of active expansion (approximately 6-8 weeks after cementation) (T1) -End of the 3 months retention period after T1, prior to appliance removal (T2)
Secondary outcomes (3)
Wong-Baker FACES Pain Rating Scale score
Pain perception will be assessed using the Wong-Baker FACES Pain Rating Scale at predefined time points during treatment. Scores will be recorded and compared between groups.
Measured: -Preoperative (T0) -After appliance cementation (within 2 weeks) -1 week after the cementation -End of active expansion (approximately 6-8 weeks after cementation) (T1) -End of the 3 months retention period after T1, prior to appliance removal (T2)
Child Perceptions Questionnaire (CPQ 8-10)
Oral health-related quality of life will be assessed using the validated Child Perceptions Questionnaire (CPQ 8-10). Total and domain scores (oral symptoms, functional limitations, emotional well-being, social well-being) will be recorded and compared between groups.
Measured: -Preoperative (T0) -After appliance cementation (within 2 weeks) -1 week after the cementation -End of active expansion (approximately 6-8 weeks after cementation) (T1) -End of the 3 months retention period after T1, prior to appliance removal (T2)
Modified Silness-Löe Plaque Index score
Oral hygiene status will be evaluated using the Modified Silness-Löe Plaque Index at predefined time points during treatment to monitor plaque accumulation and compare oral hygiene changes between groups.
Measured: -Preoperative (T0) -After appliance cementation (within 2 weeks) -1 week after the cementation -End of active expansion (approximately 6-8 weeks after cementation) (T1) -End of the 3 months retention period after T1, prior to appliance removal (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start7 Aug 2025
- Primary completion31 Jul 2026
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maxillary ConstrictionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a two-arm, parallel-group, randomized clinical trial. Eligible participants will be randomly assigned in a 1:1 ratio to receive either a conventionally fabricated rapid maxillary expansion appliance or a three-dimensional (3D) printed metal rapid maxillary expansion appliance. Allocation will be performed using sealed opaque envelopes. All participants will follow the same standardized activation and retention protocol. Outcome assessments will be conducted between baseline (T0) and the end of the retention period (T2).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Habibe Sinem Ince Bingol, DDS, Orthodontist, Study chair, Hacettepe Unversity, Faculty of Dentistry, Department of OrthodonticsSinem Tekdemir, DDS, Principal investigator, Baskent University, Faculty of Dentistry, Department of Orthodontics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07599202
- Sponsor's protocol ID
- D-KA24/41
- Other IDs
- 2025-066, 25/31
- Status last verified
- Sep 2026
- First submitted
- 23 Feb 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to institutional policies, ethical committee regulations, and patient confidentiality considerations.
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Skeletal and Dentoalveolar Effects and Patient Comfort of Conventional and 3D-Printed Maxillary Expansion Appliances in Mixed Dentition Patients
- ClinicalTrials.gov ID
- NCT07599202
- Acronym / sponsor ID
- D-KA24/41
- Conditions
- Maxillary Constriction
- Keywords
- Mixed dentition, 3D-printed orthodontic appliance, Digital orthodontics, Modified haas appliance, Transverse maxillary deficiency, Randomized clinical trial, Skeletal expansion, CPQ 8-10
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- 7 Aug 2025 (actual)
- Primary completion
- 31 Jul 2026 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 20 May 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.
The goal of this clinical trial is to determine whether two types of rapid maxillary expansion (RME) appliances produce different outcomes in children. RME is a treatment utilized to expand a narrow upper jaw. This study will include children aged 8 to 10 years who need upper jaw expansion during the mixed dentition period (when they have both temporary and permanent teeth).
The main questions this study aims to answer are:
- Do 3D-printed expansion appliances produce different skeletal and dental changes compared to conventionally fabricated appliances?
- Do children feel more comfortable with one type of appliance?
- Is there a difference in pain levels or oral hygiene between the two groups?
Researchers aimed to compare a conventionally fabricated expansion appliance manufactured in a dental laboratory with a 3D-printed expansion appliance produced digitally to determine whether the method of production affects treatment outcomes and patient comfort.
Participants:
- Being treated with one of the two expansion appliances (assigned randomly)
- Follow a standard activation protocol at home with parental guidance
- Attend regular clinic visits during expansion and retention phases
- Have dental photographs, X-rays, and digital scans taken before and after treatment
- Complete an oral health-related quality of life questionnaire
- Rate their pain using a pain scale
- Have their oral hygiene measured
Detailed description
Treatment effectiveness, amount of expansion, and patient comfort will be evaluated between the two groups. Additionally, the impact of digital appliance production on treatment outcomes and patient satisfaction will be investigated.
This prospective, parallel-group, randomized clinical trial aims to compare the skeletal, dentoalveolar, and patient-reported effects of conventionally fabricated and three-dimensional (3D) printed rapid maxillary expansion (RME) appliances in children with transverse maxillary deficiency during the mixed dentition period.
Participants aged 8-10 years who meet the predefined inclusion criteria and require rapid maxillary expansion as part of their orthodontic treatment will be enrolled.
The results are expected to contribute evidence-based guidance for orthodontists when selecting appliance fabrication methods, balancing biological effectiveness with patient comfort and quality-of-life considerations.
Findings from this study may also support future digital workflow integration strategies in pediatric orthodontic treatment planning.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a two-arm, parallel-group, randomized clinical trial. Eligible participants will be randomly assigned in a 1:1 ratio to receive either a conventionally fabricated rapid maxillary expansion appliance or a three-dimensional (3D) printed metal rapid maxillary expansion appliance. Allocation will be performed using sealed opaque envelopes. All participants will follow the same standardized activation and retention protocol. Outcome assessments will be conducted between baseline (T0) and the end of the retention period (T2).
| Arm | Type | Receives |
|---|---|---|
| Laboratory-fabricated rapid maxillary expansion appliance | Experimental | Device: Laboratory-fabricated rapid maxillary expansion applianceParticipants are treated with a laboratory-fabricated rapid maxillary expansion (RME) appliance produced on a dental cast obtained from conventional impressions. The arms of the palatal expansion screw are adapted and soldered to orthodontic molar bands on the cast model. Following adaptation, acrylic resin is added in the palatal region to increase the force distribution area. The appliance is cemented to the teeth using glass ionomer cement. Activation and retention protocols are standardized across both groups. |
| 3D-printed rapid maxillary expansion appliance | Experimental | Device: 3D-printed rapid maxillary expansion applianceParticipants are treated with a rapid maxillary expansion (RME) appliance fabricated using digital intraoral scans. Dental models are generated from intraoral scan data, and the appliance framework, including the arms and tooth-supporting components, is manufactured as a single-piece structure using three-dimensional (3D) metal printing technology with sintered cobalt-chromium alloy. After fabrication, acrylic resin is added to the palatal region to increase the force distribution area. The appliance is cemented to the teeth using glass ionomer cement. Activation and retention protocols are standardized across both groups. |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Children aged between 7 and 11 years
- In the mixed dentition period
- Fully erupted permanent first molars
- Presence of primary canines and primary second molars suitable for use as anchorage units for at least 6 months
- Angle Class I or Class II molar relationship
Key exclusion criteria (12 listed)
- Previous orthodontic treatment
- Periodontal disease
- Enamel hypocalcification or significant calcium deficiency
- Root resorption
- Signs or symptoms of temporomandibular joint dysfunction
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 |
|---|---|---|
| Laboratory-fabricated rapid maxillary expansion applianceAlso: Conventional rapid maxillary expansion appliance, Modified haas-type RME appliance used in mixed dentitionA rapid maxillary expansion (RME) appliance fabricated on a dental cast obtained from conventional impressions. The expansion screw arms are adapted and soldered to orthodontic molar bands on the cast. | Device | Laboratory-fabricated rapid maxillary expansion appliance |
| 3D-printed rapid maxillary expansion applianceAlso: Digitally fabricated modified haas-type RME appliance used in mixed dentitionA rapid maxillary expansion (RME) appliance fabricated using digital intraoral scan data. Dental models are generated from intraoral scans, and the appliance framework is manufactured as a single-piece structure using three-dimensional (3D) metal printing with sintered cobalt-chromium alloy. | Device | 3D-printed rapid maxillary expansion appliance |
Primary outcome
Change in maxillary transverse skeletal width and intermolar width from T0 to T2
Time frame: -Preoperative (T0) -After appliance cementation (within 2 weeks) -1 week after the cementation -End of active expansion (approximately 6-8 weeks after cementation) (T1) -End of the 3 months retention period after T1, prior to appliance removal (T2)
The primary outcome is the difference in transverse skeletal maxillary width and maxillary intermolar width between baseline (T0) and the end of the 3-month retention period (T2). Skeletal measurements will be obtained from standardized posteroanterior cephalometric radiographs, and dental measurements will be obtained from digital model analysis.
3 secondary outcomes
Wong-Baker FACES Pain Rating Scale score
Time frame: -Preoperative (T0) -After appliance cementation (within 2 weeks) -1 week after the cementation -End of active expansion (approximately 6-8 weeks after cementation) (T1) -End of the 3 months retention period after T1, prior to appliance removal (T2)
Child Perceptions Questionnaire (CPQ 8-10)
Time frame: -Preoperative (T0) -After appliance cementation (within 2 weeks) -1 week after the cementation -End of active expansion (approximately 6-8 weeks after cementation) (T1) -End of the 3 months retention period after T1, prior to appliance removal (T2)
Modified Silness-Löe Plaque Index score
Time frame: -Preoperative (T0) -After appliance cementation (within 2 weeks) -1 week after the cementation -End of active expansion (approximately 6-8 weeks after cementation) (T1) -End of the 3 months retention period after T1, prior to appliance removal (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 4 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to institutional policies, ethical committee regulations, and patient confidentiality considerations.
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Dento-skeletal Effects of Quadhelix Versus Mini-hyrax Expanders in Patients With Cleft Lip and Palate at the Mixed Dentition Stage: A Randomized Clinical Trial
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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.
Habibe Sinem Ince Bingol, DDS, Orthodontist study chair
Hacettepe Unversity, Faculty of Dentistry, Department of Orthodontics
Sinem Tekdemir, DDS principal investigator
Baskent University, Faculty of Dentistry, Department of Orthodontics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laboratory-fabricated rapid maxillary expansion appliance and 3D-printed rapid maxillary expansion appliance in people with Maxillary Constriction, run by Baskent 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 9 inclusion and 12 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 4 Sep 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?
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?
Change in maxillary transverse skeletal width and intermolar width from T0 to T2 (time frame: -Preoperative (T0) -After appliance cementation (within 2 weeks) -1 week after the cementation -End of active expansion (approximately 6-8 weeks after cementation) (T1) -End of the 3 months retention period after T1, prior to appliance removal (T2)). 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 4 Sep 2026.