Chewing Pattern Changes Before and After Space Maintainer Placement in Children

NCT07828158 | Not Yet Recruiting

• 1 other identifier: chewing.p
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Premature Loss of Primary Molars

Keywords

Space Maintainer; Chewing Pattern; Two-Color Chewing Gum Test; Pediatric Dentistry

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline and 4 weeks after space maintainer placement

Study Arms (1)

Children Receiving a Unilateral 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.

Device: Band-and-Loop Space Maintainer

Interventions

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.

Children Receiving a Unilateral Band-and-Loop Space Maintainer

Eligibility Criteria

• Age: 6 Years - 10 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University

Istanbul, Maltepe, Turkey (Türkiye)

Location

Central Study Contacts

afra savas

CONTACT

90 5343279274; aafranursavas@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2026
• First Posted: September 18, 2026
• Study Start: September 20, 2026
• Primary Completion (Estimated): December 20, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: September 21, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)