About this trial
This prospective observational study aims to evaluate changes in chewing patterns and chewing performance in children before and after placement of a unilateral fixed band-and-loop space maintainer. Children aged 6-10 years who require a space maintainer as part of routine clinical care will be evaluated before appliance placement and again four weeks after placement. Chewing pattern will be assessed by observing the preferred chewing side during standardized chewing trials, and chewing performance will be evaluated using a two-color chewing gum test scored with the Orophys Subjective Assessment Scale. No additional invasive procedure will be performed for research purposes; the space maintainer treatment will be provided as part of routine clinical care.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Children aged 6-10 years
Premature loss or extraction of a primary molar in the maxilla or mandible with a clinical indication for a unilateral fixed band-and-loop space maintainer
The abutment tooth for the space maintainer is vital and either sound or appropriately restored
Complete dentition on the contralateral side of the arch to allow reliable assessment of chewing function
Disqualifiers
Severe developmental delay, severe behavioral problems, or neuromuscular disorders that may directly affect chewing function, muscle activity, or treatment cooperation
Temporomandibular joint disorder
Current orthodontic treatment
Anterior or posterior crossbite, open bite, or other skeletal or dental malocclusions that may affect chewing function
Trial population
Children aged 6-10 years attending the Department of Pediatric Dentistry at Marmara University Faculty of Dentistry who have premature loss of a primary molar and a clinical indication for a unilateral fixed band-and-loop space maintainer. Eligible children will be recruited prospectively from patients scheduled to receive space maintainer treatment as part of routine clinical care.
Trial design
Cohort
Prospective
Treatments tested in this trial
Band-and-Loop Space Maintainer
DeviceA unilateral fixed band-and-loop space maintainer will be placed as part of routine clinical care following premature loss of a primary molar. The appliance will be cemented to the abutment tooth with glass ionomer cement, and occlusion will be checked after placement. The space maintainer is not assigned for research purposes; it is clinically indicated before study enrollment.
Treatment groups
Trial outcomes
Primary outcomes
Change in Masticatory Performance
Change in masticatory performance from before space maintainer placement to 4 weeks after placement, assessed using a two-color chewing gum test. After 20 chewing cycles, color mixing will be scored using the Orophys Subjective Assessment Scale from SA1 to SA5, with higher scores indicating more complete color mixing and better masticatory performance.
Change in Chewing Pattern
Change in chewing pattern from before space maintainer placement to 4 weeks after placement. The dominant chewing side (right/left) will be observed during seven standardized chewing trials. Children using the same side in at least four of seven trials will be classified as unilateral chewers; those showing side alternation will be classified as bilateral chewers.
Sponsors and contacts
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