Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in Turkey / NCT07828158
Starting soon Observational

Chewing Pattern Changes Before and After Space Maintainer Placement in Children

NCT07828158 · tracked via the Priya Life Science Turkey tracker
Sponsor
Marmara University
Phase
Observational
Started
2026-09-20
Last updated
2026-09-21

Condition(s) studied

Premature Loss of Primary Molars

Investigational drug(s) / intervention(s)

Band-and-Loop Space Maintainer

Band-and-Loop Space Maintainer: 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.

Study 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.

Eligibility

Sex
ALL
Min age
6 Years
Max age
10 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Change in Masticatory Performance — 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.
  • Change in Chewing Pattern — 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.

Trial sites (1)

FacilityCityRegionStatus
Marmara University Istanbul Maltepe

More Marmara University trials in Turkey

Investigation of Medial Longitudinal Arch and Foot Function in Patients With Lipedema Recruiting
AI-Based Prediction of Root Coverage Outcome From Intraoral Photographs Recruiting
Comparison of Intrathecal Morphine and Rectus Sheath Block for Postoperative Pain Management After Lower Abdominal Surgery With Midline Incision Active, not recruiting
The Effect of Inspiratory Exercises on Diaphragm and Intercostal Muscle Thickness in Stroke Patients Starting soon
Physicians' Perception About Patient Pain in Flexible Cystoscopy With Local Anesthesia Enrolling by invitation
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07828158 on ClinicalTrials.gov ↗ ← All trials in Turkey