Dental CariesNCT07271901
Masticatory Performance in Mixed Dentition Children Before and After Dental Treatment
A study testing Dental Treatment in people with Dental Caries, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 9 years
- Conditions the study is for
- Dental Caries
- What is being tested?
- Dental Treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jan 2025to 30 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Dental Caries
- Being tested
- Dental Treatment
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental TreatmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Dental Treatment | Experimental | Not described Receives: Other: Dental Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Variance of Hue (VOH) Values Before and After Dental Treatment
Measured: Baseline and 3 months after dental treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start30 Jan 2025
- Primary completion30 Jan 2025
- Study completion30 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ezgi Turkyilmaz, TC Erciyes University
- Investigators
- Ezgi Turkyilmaz, Principal investigator, Erciyes University Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07271901
- Sponsor's protocol ID
- ERU-PEDO-2025-MP01
- Status last verified
- Nov 2025
- First submitted
- 26 Nov 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Masticatory Performance in Mixed Dentition Children Before and After Dental Treatment: an in Vivo Assessment Using a Two-coloured Chewing Gum Mixing Test
- ClinicalTrials.gov ID
- NCT07271901
- Acronym / sponsor ID
- ERU-PEDO-2025-MP01
- Conditions
- Dental Caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 30 Jan 2025 (actual)
- Primary completion
- 30 Jan 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 9 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dental Treatment | Experimental | Other: Dental Treatment |
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dental TreatmentComprehensive 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. | Other | Dental Treatment |
Primary outcome
Change in Variance of Hue (VOH) Values Before and After Dental Treatment
Time frame: Baseline and 3 months after dental treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ezgi Turkyilmaz principal investigator
Erciyes University Faculty of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dental Treatment in people with Dental Caries, run by TC Erciyes University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Variance of Hue (VOH) Values Before and After Dental Treatment (time frame: Baseline and 3 months after dental treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2025.