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Timing, Trajectories and Prediction in Severe Dental Crowding: The Create SPACE (cSPACE)
Sponsor: Vastra Gotaland Region
Summary
Dental crowding is the most common malocclusion affecting up to 45% of the population and represents one of the leading reasons for seeking orthodontic treatment. Severe crowding may have a negatively impact on oral health related quality of life particularly psychosocial well-being and self-perceived dental appearance. In cases of severe crowding, extraction of four permanent teeth may be required to create sufficient space for proper alignment. Several treatment strategies are currently used, but there is a lack of scientific evidence regarding the optimal timing of tooth extraction and orthodontic treatment to achieve the best outcomes. The trial compare 1) late first premolar extraction with fixed orthodontic treatment, (2) early first premolar extraction with planned fixed orthodontic treatment, and (3) early first premolar extraction followed by observation, with fixed treatment provided only if indicated. The study will evaluate treatment need, occlusal outcomes, spontaneous dental development, patient-reported outcomes, adverse effects, treatment efficiency, and cost-effectiveness.
Official title: Timing, Trajectories and Prediction in Severe Dental Crowding: The Create SPACE (cSPACE) Multicenter Randomized Controlled Trial.
Key Details
Gender
All
Age Range
8 Years - 19 Years
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2027-03-01
Completion Date
2036-03-01
Last Updated
2026-11-02
Healthy Volunteers
No
Interventions
Early first premolar extraction with observation
Extraction of all first premolars during the mixed dentition stage, followed by observation without active orthodontic treatment. Comprehensive orthodontic treatment is offered at 18 years of age if orthodontic treatment need persists.
Early first premolar extraction with planned fixed orthodontic treatment
Extraction of all first premolars during the mixed dentition stage. No comprehensive orthodontic treatment is provided immediately after extraction. Orthodontic treatment with fixed appliance is initiated at the age of 14 years, when the permanent dentition is established.