Maxillary Constriction
Conditions
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
Brief 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
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.
Interventions
DEVICELaboratory-fabricated rapid maxillary expansion appliance
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.
DEVICE3D-printed rapid maxillary expansion appliance
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.
Sponsors
Baskent University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Due to the visible differences between the appliances, participants and treating clinicians cannot be blinded. However, all cephalometric and digital model measurements will be performed by an independent outcome assessor who is blinded to group allocation. Radiographic and digital files will be coded prior to analysis.
Intervention 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).
Eligibility
Sex/Gender
ALL
Age
7 Years to 11 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in maxillary transverse skeletal width and intermolar width from T0 to T2 | -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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wong-Baker FACES Pain Rating Scale score | -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) | 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. |
| Child Perceptions Questionnaire (CPQ 8-10) | -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) | 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. |
| Modified Silness-Löe Plaque Index score | -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) | 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. |
Countries
Turkey (Türkiye)
Contacts
STUDY_CHAIRHabibe Sinem Ince Bingol, DDS, Orthodontist
Hacettepe Unversity, Faculty of Dentistry, Department of Orthodontics
PRINCIPAL_INVESTIGATORSinem Tekdemir, DDS
Baskent University, Faculty of Dentistry, Department of Orthodontics
Outcome results
None listed