Comparison of Laboratory-Fabricated and 3D-Printed Rapid Maxillary Expansion Appliances (NCT07599202) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Comparison of Laboratory-Fabricated and 3D-Printed Rapid Maxillary Expansion Appliances
Turkey (Türkiye)48 participantsStarted 2025-08-07
Plain-language 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. 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
Who can participate
Age range
7 Years – 11 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
* 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
Exclusion Criteria:
* 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
* 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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in maxillary transverse skeletal width and intermolar width from T0 to T2
Timeframe: -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)