Comparison of Laboratory-Fabricated and 3D-Printed Rapid Maxillary Expansion Appliances

NCT07599202 | Active Not Recruiting

• 3 other identifiers: D-KA24/412025-06625/31
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

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; Wong-Baker Pain Scale; Modified Silness-Löe Plaque Index; Semi-rapid maxillary expansion

Outcome Measures

Primary Outcomes (1)

• 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.

  -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

  -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)

  -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

  -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)

Other Outcomes (1)

• 3D digital model superimposition-based surface deviation

  -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)

Study Arms (2)

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.

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.

Device: 3D-printed rapid maxillary expansion appliance

Interventions

Laboratory-fabricated rapid maxillary expansion appliance DEVICE

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.

Also known as: Conventional rapid maxillary expansion appliance, Modified haas-type RME appliance used in mixed dentition

Laboratory-fabricated rapid maxillary expansion appliance

3D-printed rapid maxillary expansion appliance DEVICE

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.

Also known as: Digitally fabricated modified haas-type RME appliance used in mixed dentition

3D-printed rapid maxillary expansion appliance

Eligibility Criteria

• Age: 7 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Baskent University: lead

Study Sites (1)

Baskent University Faculty of Dentistry, Department of Orthodontics

Ankara, 06490, Turkey (Türkiye)

Location

Study Officials

• Habibe Sinem Ince Bingol, DDS, Orthodontist

  Hacettepe Unversity, Faculty of Dentistry, Department of Orthodontics

  STUDY CHAIR

• Sinem Tekdemir, DDS

  Baskent University, Faculty of Dentistry, Department of Orthodontics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: February 23, 2026
• First Posted: May 20, 2026
• Study Start: August 7, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)