Evaluation of Changes in Chewing Pattern in Children Before and After Space Maintainer Placement
| Registry | NCT07828158 |
|---|---|
| Status | Not yet recruiting |
| Study type | Observational |
| Enrollment | 102 (Estimated) |
| Sponsor | Marmara University (Other) |
| Conditions | Premature Loss of Primary Molars |
| Interventions | Band-and-Loop Space Maintainer (Device) |
| Dates | start 2026-09-20 (estimated), primary completion 2026-12-20 (estimated), completion 2026-12-30 (estimated), first posted 2026-09-18, last updated 2026-09-21 |
| Locations | 1 site in Turkey (Türkiye) |
Related Papers Related Patents Related Grants Related Experts
All trials for Premature Loss of Primary Molars All trials of Band-and-Loop Space Maintainer
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Children Receiving a Unilateral Band-and-Loop Space Maintainer | Device: Band-and-Loop Space Maintainer | Children aged 6-10 years with premature loss of a primary molar and a clinical indication for a unilateral fixed band-and-loop space maintainer. Chewing pattern and chewing performance will be assessed before space maintainer placement and again four weeks after placement. |
Sex: All, ages: 6 Years to 10 Years
Inclusion Criteria: * 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 * No systemic condition affecting chewing function * Written informed consent provided by a parent or legal guardian; children aged 9 years and older also provide written assent Exclusion Criteria: * 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 * Additional missing teeth in the contralateral arch, including hypodontia * Craniofacial anomalies, including cleft lip and/or palate syndromes * Systemic conditions requiring special medical precautions or antibiotic prophylaxis during routine dental treatment
| Facility | City | Country | Status |
|---|---|---|---|
| Marmara University | Istanbul, Maltepe | Turkey (Türkiye) |