Chewing Pattern Changes Before and After Space Maintainer Placement in Children

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-10
SponsorMarmara University

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Band-and-Loop Space Maintainer

    Device

    A 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

102 Participants
are divided into 1 treatment group
Group A: Children Receiving a Unilateral Band-and-Loop Space Maintainer1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline and 4 weeks after space maintainer placement
2

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.

Time frame
Baseline and 4 weeks after space maintainer placement

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: