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Tooth-Borne (TBA) Versus Hybrid Expanders (HA) in Surgically Assisted Rapid Maxillary Expansion (SARME)
Sponsor: Aalborg University Hospital
Summary
This randomized clinical trial will compare two types of expansion appliances used with surgically assisted rapid maxillary expansion (SARME) in adults with a narrow upper jaw. SARME is a surgical and orthodontic treatment used to widen the upper jaw when orthodontic expansion alone is not sufficient. The study will investigate whether a tooth-borne appliance, which is supported by the teeth, and a hybrid appliance, which is supported by both the teeth and two small screws placed in the palate, produce different treatment outcomes. A total of 32 adults scheduled for SARME at Aalborg University Hospital in Denmark and Lund University Hospital in Sweden will be randomly assigned to treatment with either the tooth-borne appliance or the hybrid appliance. Participants will be examined before surgery, after completion of the expansion phase, and six months after completion of expansion. Assessments will include cone-beam computed tomography (CBCT), digital dental scans, facial imaging, periodontal examinations, recording of complications, and questionnaires about pain, recovery, oral health-related quality of life, general quality of life, and treatment experience. The main outcome of the study is skeletal relapse, meaning how much of the widening of the upper jaw is lost between the end of expansion and the six-month follow-up. Other outcomes include the amount of skeletal and dental expansion, tooth tipping, changes in the supporting bone and gums around the teeth, facial soft-tissue changes, complications, recovery, and patient-reported quality of life. The study aims to determine whether one appliance provides better stability or fewer unwanted effects and thereby improve future treatment recommendations for adults undergoing SARME.
Official title: Surgically Assisted Rapid Maxillary Expansion (SARME) With Tooth-Borne Appliance Compared With Hybrid Appliance: A Randomised Controlled Trial Assessing Clinical, Radiographic, and Patient-Reported Outcome Measures
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
32
Start Date
2027-01
Completion Date
2031-12
Last Updated
2026-09-30
Healthy Volunteers
No
Conditions
Interventions
Tooth-Borne Maxillary Expansion Appliance
A CAD/CAM-fabricated tooth-borne maxillary expansion appliance used during surgically assisted rapid maxillary expansion (SARME). The appliance consists of four printed metal bands cemented to the maxillary first premolars and first molars and connected to a palatal expansion mechanism. Anchorage is provided exclusively by the teeth, with no palatal mini-implants. The appliance is cemented before surgery. Following a postoperative latency period of 5-7 days, the appliance is activated at approximately 0.5 mm per day until the planned expansion or clinical overcorrection is achieved. The appliance is subsequently maintained passively during the six-month consolidation period.
Hybrid Tooth-Bone-Borne Maxillary Expansion Appliance
A CAD/CAM-fabricated hybrid tooth-bone-borne maxillary expansion appliance used during surgically assisted rapid maxillary expansion (SARME). The appliance consists of four printed metal bands on the maxillary first premolars and first molars connected to a palatal expansion mechanism. In addition to dental anchorage, skeletal anchorage is provided by two palatal mini-implants (BENEfit® DIRECT screws, 2.0 mm diameter and 9 mm length) inserted immediately before surgery and connected to the expander. Following a postoperative latency period of 5-7 days, the appliance is activated at approximately 0.5 mm per day until the planned expansion or clinical overcorrection is achieved, followed by a six-month passive consolidation period.
Locations (2)
Department of Oral and Maxillofacial Surgery, Aalborg University Hospital
Aalborg, Denmark
Skåne University Hospital
Lund, Skåne County, Sweden