Tooth-Borne (TBA) Versus Hybrid Expanders (HA) in Surgically Assisted Rapid Maxillary Expansion (SARME)
NCT: NCT07849855 · NOT_YET_RECRUITING
Brief 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.
Frequently Asked Questions
What is Tooth-Borne (TBA) Versus Hybrid Expanders (HA) in Surgically Assisted Rapid Maxillary Expansion (SARME)?
Tooth-Borne (TBA) Versus Hybrid Expanders (HA) in Surgically Assisted Rapid Maxillary Expansion (SARME) is a clinical trial registered under NCT07849855. Current status: NOT_YET_RECRUITING.
What is the status of NCT07849855?
The current status of NCT07849855 (Tooth-Borne (TBA) Versus Hybrid Expanders (HA) in Surgically Assisted Rapid Maxillary Expansion (SARME)) is: NOT_YET_RECRUITING.
When did Tooth-Borne (TBA) Versus Hybrid Expanders (HA) in Surgically Assisted Rapid Maxillary Expansion (SARME) start?
Tooth-Borne (TBA) Versus Hybrid Expanders (HA) in Surgically Assisted Rapid Maxillary Expansion (SARME) started on 2027-01.
Official Source
View on ClinicalTrials.gov →Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.