Children’s dental anxiety Mental and Behavioural Disorders
Conditions
Interventions
Current interventions as of 15/05/2025:
This 5-year study is a multi-region, randomised controlled trial involving 600 children (aged 8-16 years), and where agreeable a parent/carer, in up to 40 pri
scores will be compared between groups using a covariance pattern linear mixed model, adjusting for baseline value, other pertinent baseline covariates, time and an interaction between treatment group
one dental professional will be randomly assigned to receive the tr
Sponsors
Sheffield Teaching Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
8 Years to 16 Years
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 25/07/2023: Child: 1. Patients aged 8-16 years, inclusive 2. Child self-reported dental anxiety 3. Not requiring urgent dental treatment 4. Attending for a dental assessment and found to require a course of treatment for their presenting dental condition (categorised as level one complexity by NHS England), involving at least two additional visits and within the scope of practice of the CALM dental professional 5. Child able to read and use written English, required to receive the intervention and complete questionnaires Parent/Carer: 1. Parent/carer able to complete consent forms (with the support of an interpreter if necessary) _____ Previous inclusion criteria as of 23/11/2022: Child: 1. Patients aged 9-16 years, inclusive 2. Child self-reported dental anxiety 3. Not requiring urgent dental treatment 4. Attending for a dental assessment and found to require a course of treatment for their presenting dental condition (categorised as level one complexity by NHS England), involving at least two additional visits and within the scope of practice of the CALM dental professional 5. Child able to read and use written English, required to receive the intervention and complete questionnaires Parent/Carer: 1. Parent/carer able to complete consent forms (with the support of an interpreter if necessary) _____ Previous inclusion criteria: Child: 1. Patients aged 9-16 years, inclusive 2. Attending for a dental assessment and found to require a course of treatment for their presenting dental condition (categorised as level one complexity by NHS England), involving at least two additional visits 3. Not requiring urgent dental treatment 4. Child able to read and use written English, required to receive the intervention and complete questionnaires 5. Child self-reported dental anxiety based on a screening question. Parent: 1. Parent/carer able to complete consent forms (with the support of an interpreter if necessary)
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 25/07/2023: Child: 1. Patients younger than 8 years or older than 16 years 2. A sibling of a child patient recruited to the trial 3. No self-reported dental anxiety 4. Seen for an assessment with an acute presentation and in need of immediate dental treatment 5. Have previously been seen for an assessment and part-way through a prescribed course of dental treatment 6. Seen for an assessment but not requiring more than one further visit to complete any necessary treatment 7. Requiring procedures during the course of treatment that fall outside of the scope of the practice of the dental professionals involved 8. Requiring referral to a specialist for more complex treatment needs (categorised as level two or three complexity by NHS England) 9. Child unable to read and use written English Parent/Carer: 1. Parent /carer unable to complete consent forms (even with support). _____ Previous exclusion criteria as of 23/11/2022: Child: 1. Patients younger than 9 years or older than 16 years 2. A sibling of a child patient recruited to the trial 3. No self-reported dental anxiety 4. Seen for an assessment with an acute presentation and in need of immediate dental treatment 5. Have previously been seen for an assessment and part-way through a prescribed course of dental treatment 6. Seen for an assessment but not requiring more than one further visit to complete any necessary treatment 7. Requiring procedures during the course of treatment that fall outside of the scope of the practice of the dental professionals involved 8. Requiring referral to a specialist for more complex treatment needs (categorised as level two or three complexity by NHS England) 9. Child unable to read and use written English Parent/Carer: 1. Parent /carer unable to complete consent forms (even with support). _____ Previous exclusion criteria: Child: 1. Patients younger than 9 years or older than 16 years 2. Have previously been seen for an assessment and part-way through a prescribed course of dental treatment 3. Seen for an assessment but not requiring more than one further visit to complete any necessary treatment 4. Seen for an assessment with an acute presentation and in need of immediate dental treatment 5. Requiring referral to a specialist for more complex treatment needs (categorised as level two or three complexity by NHS England) 6. Child unable to read and use written English Parent: 1. Parent/carer unable to complete consent forms (even with support)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dental anxiety measured using the Modified Child Dental Anxiety Scale (MCDAS) score at 12 months post-randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Dental anxiety (MCDAS) measured at the end of the course of treatment. 2. Child health-related quality of life and oral health-related quality of life (Child Health Utility-9D and CARIES-QC) at the end of the course of treatment and 12 months post-randomisation. 3. Dental anxiety of the parent/carer (Modified Dental Anxiety Scale) measured at the end of the course of treatment and 12 months post-randomisation. 4. Attended, cancelled, and missed appointments will be recorded during the course of treatment and for the 12 month follow up period. 5. The need for referral to secondary care and use of sedation or general anaesthesia (GA) will be recorded throughout for children in both groups along with treatment provided. | — |
Countries
England, United Kingdom, Wales
Contacts
Public ContactLiz Cross
Outcome results
None listed