Children's Dental FearQCCNCT07896551
QCC Intervention for Dental Fear in Preschool Children: A Non-Randomized Controlled Trial
A study testing Usual dental care in people with Children's Dental Fear, run by Army Medical University, China at 1 site in China.
Trial summary
Management of children's dental fear (CDF) typically relies on conventional one-on-one isolated behavioral interventions delivered by individual clinicians at the chairside. However, these traditional approaches often fail to address fundamental organizational and systemic issues, such as the lack of standardized… Read more about this study
- Who is it for?
- Ages 3 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Children's Dental Fear
- What is being tested?
- Usual dental care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 8 Jan 2024to 20 Apr 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 3 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 3 to 6 years requiring dental treatment;
- Children with normal vision and hearing, free from systemic diseases or mental disorders, whose guardians provided informed consent;
- Children's Fear Survey Schedule-Dental Subscale (CFSS-DS) score ≥ 38.
Who cannot join
- Children unable to cooperate with questionnaire assessment;
- Children whose guardians declined participation;
- Children lost to follow-up during the study period.
Trial locations and contacts
1 site in 1 country.
China1 site
Daping Hospital, Army Medical University.
Chongqing, Chongqing Municipality, 400042
About this study
Official title: Effect of Quality Control Circle Intervention on Alleviating Dental Fear in Preschool Children: A Non-Randomized Controlled Trial
Management of children's dental fear (CDF) typically relies on conventional one-on-one isolated behavioral interventions delivered by individual clinicians at the chairside. However, these traditional approaches often fail to address fundamental organizational and systemic issues, such as the lack of standardized pre-treatment assessment tools, inadequate systematic training for clinical staff, and insufficient sustained family engagement. To tackle these challenges, our team initiated a quality control circle (QCC) project aimed at reducing the prevalence of CDF among preschool children.
- Conditions
- Children's Dental Fear
- Being tested
- Quality Control Circle Intervention, Usual dental care
- Keywords
- Quality Control Circles, Children's Dental Fear, Oral Health, Behavioral Guidance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality Control Circle InterventionBehavioural
Children receive quality control circle (QCC) intervention for alleviating dental fear before dental treatment, in addition to routine dental care.
Usual dental careBehavioural
Children receive usual routine dental care (conventional one-on-one chairside behavioral guidance), without QCC intervention.
| Study group | Role | What they receive |
|---|---|---|
| Quality Control Circle Intervention | Experimental | Children receive quality control circle (QCC) intervention for alleviating dental fear before dental treatment, in addition to routine dental care. Receives: Behavioral: Quality Control Circle Intervention |
| Usual dental care | Active comparator | Children receive usual routine dental care (conventional one-on-one chairside behavioral guidance), without QCC intervention. Receives: Behavioral: Usual dental care |
What is being measured
The primary outcome is the main question the study is designed to answer.
The prevalence of children's dental fear.
The prevalence of children's dental fear was assessed as the primary outcome using the Children's Fear Survey Schedule-Dental Subscale (CFSS-DS).
Measured: Immediately before dental treatment.
Secondary outcomes (3)
Houpt Scale for children's treatment cooperation scores.
Measured: Immediately before dental treatment.
Parental satisfaction assessment scores.
Measured: Immediately before dental treatment.
Parental Mastery of Basic Oral Health Knowledge scores
Measured: Immediately before dental treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start8 Jan 2024
- Primary completion10 Jan 2025
- Study completion20 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Children's Dental FearStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Army Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mingling Yi, Army Medical University, China
- Investigators
- Mingling Yi, Bachelor of Science in Nursing, Study director, Army Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07896551
- Sponsor's protocol ID
- QCC2024388
- Acronym
- QCC
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized individual participant data (including baseline characteristics, CFSS-DS scores, and outcome data) will be available upon reasonable request after publication of the primary study manuscript. Data will be shared following approval of a formal data access request.
Publications
Zhang D, Yan Y, Liu TF. Key factors influencing the effectiveness of hospital quality management tools: using the quality control circle as an example-a cross-sectional study. BMJ Open. 2022 Feb 22;12(2):e049577. doi: 10.1136/bmjopen-2021-049577.
PubMed 35193899Zhang D, Liao M, Liu T. Implementation and Promotion of Quality Control Circle: A Starter for Quality Improvement in Chinese Hospitals. Risk Manag Healthc Policy. 2020 Aug 18;13:1215-1224. doi: 10.2147/RMHP.S261998. eCollection 2020.
PubMed 32884382Grisolia BM, Dos Santos APP, Dhyppolito IM, Buchanan H, Hill K, Oliveira BH. Prevalence of dental anxiety in children and adolescents globally: A systematic review with meta-analyses. Int J Paediatr Dent. 2021 Mar;31(2):168-183. doi: 10.1111/ipd.12712. Epub 2020 Sep 9.
PubMed 33245591
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Quality Control Circle Intervention on Alleviating Dental Fear in Preschool Children: A Non-Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07896551
- Acronym / sponsor ID
- QCC / QCC2024388
- Conditions
- Children's Dental Fear
- Keywords
- Quality Control Circles, Children's Dental Fear, Oral Health, Behavioral Guidance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Army Medical University, ChinaUniversity, hospital or other
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- 10 Jan 2025 (actual)
- Study completion
- 20 Apr 2025 (actual)
- First posted
- 27 Oct 2026 (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.
Management of children's dental fear (CDF) typically relies on conventional one-on-one isolated behavioral interventions delivered by individual clinicians at the chairside. However, these traditional approaches often fail to address fundamental organizational and systemic issues, such as the lack of standardized pre-treatment assessment tools, inadequate systematic training for clinical staff, and insufficient sustained family engagement. To tackle these challenges, our team initiated a quality control circle (QCC) project aimed at reducing the prevalence of CDF among preschool children.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quality Control Circle Intervention | Experimental | Behavioral: Quality Control Circle InterventionChildren receive quality control circle (QCC) intervention for alleviating dental fear before dental treatment, in addition to routine dental care. |
| Usual dental care | Active comparator | Behavioral: Usual dental careChildren receive usual routine dental care (conventional one-on-one chairside behavioral guidance), without QCC intervention. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children aged 3 to 6 years requiring dental treatment;
- Children with normal vision and hearing, free from systemic diseases or mental disorders, whose guardians provided informed consent;
- Children's Fear Survey Schedule-Dental Subscale (CFSS-DS) score ≥ 38.
Key exclusion criteria (3 listed)
- Children unable to cooperate with questionnaire assessment;
- Children whose guardians declined participation;
- Children lost to follow-up during the study period.
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 |
|---|---|---|
| Quality Control Circle InterventionChildren receive quality control circle (QCC) intervention for alleviating dental fear before dental treatment, in addition to routine dental care. | Behavioural | Quality Control Circle Intervention |
| Usual dental careChildren receive usual routine dental care (conventional one-on-one chairside behavioral guidance), without QCC intervention. | Behavioural | Usual dental care |
Primary outcome
The prevalence of children's dental fear.
Time frame: Immediately before dental treatment.
The prevalence of children's dental fear was assessed as the primary outcome using the Children's Fear Survey Schedule-Dental Subscale (CFSS-DS).
3 secondary outcomes
Houpt Scale for children's treatment cooperation scores.
Time frame: Immediately before dental treatment.
Parental satisfaction assessment scores.
Time frame: Immediately before dental treatment.
Parental Mastery of Basic Oral Health Knowledge scores
Time frame: Immediately before 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 27 Oct 2026.
- Background: PubMed 35193899Zhang D, Yan Y, Liu TF. Key factors influencing the effectiveness of hospital quality management tools: using the quality control circle as an example-a cross-sectional study. BMJ Open. 2022 Feb 22;12(2):e049577. doi: 10.1136/bmjopen-2021-049577.
- Background: PubMed 32884382Zhang D, Liao M, Liu T. Implementation and Promotion of Quality Control Circle: A Starter for Quality Improvement in Chinese Hospitals. Risk Manag Healthc Policy. 2020 Aug 18;13:1215-1224. doi: 10.2147/RMHP.S261998. eCollection 2020.
- Background: PubMed 33245591Grisolia BM, Dos Santos APP, Dhyppolito IM, Buchanan H, Hill K, Oliveira BH. Prevalence of dental anxiety in children and adolescents globally: A systematic review with meta-analyses. Int J Paediatr Dent. 2021 Mar;31(2):168-183. doi: 10.1111/ipd.12712. Epub 2020 Sep 9.
- Individual participant dataSharing planned: Yes. Anonymized individual participant data (including baseline characteristics, CFSS-DS scores, and outcome data) will be available upon reasonable request after publication of the primary study manuscript. Data will be shared following approval of a formal data access request.
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.
Mingling Yi, Bachelor of Science in Nursing study director
Army Medical University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Usual dental care in people with Children's Dental Fear, run by Army Medical University, China at 1 site in China.
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 3 inclusion and 3 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 27 Oct 2026. 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 China. 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?
The prevalence of children's dental fear. (time frame: Immediately before dental treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07896551, which also lists 3 linked publications.
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 27 Oct 2026.