- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07271901
Masticatory Performance in Mixed Dentition Children Before and After Dental Treatment
November 26, 2025 updated by: Ezgi Turkyilmaz, TC Erciyes University
Masticatory Performance in Mixed Dentition Children Before and After Dental Treatment: an in Vivo Assessment Using a Two-coloured Chewing Gum Mixing Test
This prospective clinical study aimed to evaluate the effects of dental treatment on masticatory performance and food preferences in children during the mixed dentition period.
A total of 100 children aged 6 to 9 years were included and categorized into three groups based on the Caries Assessment Spectrum and Treatment (CAST) index (CAST 5, 6, and 7).
Masticatory performance was objectively assessed using a two-coloured chewing gum mixing test (Vivident Fruit Swing) and analyzed with ViewGum© software by calculating the Variance of Hue (VOH) value.
Assessments were performed before and three months after dental treatment.
Additional variables such as posterior occlusal contacts, body mass index (BMI), and pain scores were also recorded.
The study aimed to determine the improvement in masticatory function and the potential association between oral rehabilitation and food preference changes in children during the mixed dentition period.
Study Overview
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Kayseri, Turkey (Türkiye)
- Erciyes University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Children aged 6 to 9 years in the mixed dentition period Presence of dental caries categorized as CAST codes 5, 6, or 7 Children with fully erupted permanent first molars Medically healthy children (ASA I) Cooperative or manageable with nonpharmacological behavior guidance techniques Written informed consent obtained from parents or legal guardians
Exclusion Criteria:
- Children with systemic or neurological disorders affecting mastication or swallowing History of orthodontic or prosthetic treatment Presence of temporomandibular joint dysfunction Use of medications influencing salivary flow or muscle activity Uncooperative children for whom the chewing test could not be standardized
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Dental Treatment
|
Comprehensive dental treatment including restorative procedures, pulp therapy, and extractions performed under local anesthesia as indicated.
The intervention aimed to eliminate dental caries and restore normal oral function.
Masticatory performance was evaluated before and three months after treatment using a two-coloured chewing gum mixing test and analyzed with ViewGum© software to assess improvement in chewing ability.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in Variance of Hue (VOH) Values Before and After Dental Treatment
Time Frame: Baseline and 3 months after dental treatment
|
Baseline and 3 months after dental treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ezgi Turkyilmaz, Erciyes University Faculty of Dentistry
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 30, 2025
Primary Completion (Actual)
January 30, 2025
Study Completion (Actual)
July 30, 2025
Study Registration Dates
First Submitted
November 26, 2025
First Submitted That Met QC Criteria
November 26, 2025
First Posted (Estimated)
December 9, 2025
Study Record Updates
Last Update Posted (Estimated)
December 9, 2025
Last Update Submitted That Met QC Criteria
November 26, 2025
Last Verified
November 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ERU-PEDO-2025-MP01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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