NCT07271901

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 30, 2025

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 26, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 9, 2025

Completed
Last Updated

December 9, 2025

Status Verified

November 1, 2025

Enrollment Period

Same day

First QC Date

November 26, 2025

Last Update Submit

November 26, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in Variance of Hue (VOH) Values Before and After Dental Treatment

    Baseline and 3 months after dental treatment

Study Arms (1)

Dental Treatment

EXPERIMENTAL
Other: Dental Treatment

Interventions

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.

Dental Treatment

Eligibility Criteria

Age6 Years - 9 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erciyes University

Kayseri, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dental Caries

Interventions

Dental Care

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

DentistryDental Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Ezgi Turkyilmaz

    Erciyes University Faculty of Dentistry

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant, Department of Pediatric Dentistry

Study Record Dates

First Submitted

November 26, 2025

First Posted

December 9, 2025

Study Start

January 30, 2025

Primary Completion

January 30, 2025

Study Completion

July 30, 2025

Last Updated

December 9, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations