Chewing Pattern Changes Before and After Space Maintainer Placement in Children

N/ANot Yet RecruitingNCT07828158

Marmara University102 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

102

Conditions

Premature Loss of Primary Molars

Interventions

Band-and-Loop Space MaintainerDEVICE

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.

Eligibility

Sex: ALLMin age: 6 YearsMax age: 10 Years

Medical Language ↔ Plain English

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

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.

Time frame: Baseline and 4 weeks after space maintainer placement

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.