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NCT Number: NCT07828158

Chewing Pattern Changes Before and After Space Maintainer Placement in Children

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.

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Key information

Conditions

Premature Loss of Primary Molars

Age range

6 year–10 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in Masticatory Performance

    Time frame: Baseline and 4 weeks after space maintainer placement

    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.

  2. Change in Chewing Pattern

    Time frame: Baseline and 4 weeks after space maintainer placement

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

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CONTACT

[email protected]

90 5343279274

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study title

Evaluation of Changes in Chewing Pattern in Children Before and After Space Maintainer Placement

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Sep 18, 2026
Registry last updated
Sep 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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