Dental caries Oral Health Dental caries
Conditions
Interventions
Participants will be randomly allocated to receive either of the following investigational medicinal products (IMPs). Participants will be treated within two weeks of being randomised.
Sponsors
Cardiff University (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Year 2 children (aged 6 - 7 years) attending the schools participating in the current Cardiff and Vale University Health Board Fissure Sealant Programme 2. Children with at least one-fully erupted caries-free first permanent molar
Exclusion criteria
Exclusion criteria: Applied at screening: 1. Children whose parents refuse consent 2. Children who at the time of the clinical examination or PFS/FV placement refuse assent 3. Children whose medical history precludes inclusion (i.e., those with a history of hospitalisation for asthma, or severe allergies, or allergy to Elastoplast) 4. Children with ulcerative gingivitis or stomatitis 5. Children with any facial or oral infections, e.g., cold sores 6. Children with known sensitivity to colophony (kolophonium), or any of the product ingredients (e.g. methylacrylate in PFS) 7. children with any abnormality of the lips, face or soft tissues of the mouth considered by the investigator to preclude acceptable application of either PFS or FV 8. Children who are showing obvious signs of systemic illness (e.g. colds, 'flu, chicken pox, etc.,) should also be excluded on that day Applied at baseline examination: 9. Children without at least one fully-erupted caries-free first permanent molar
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Development of dental caries on the occlusal surface of first permanent molars at 36 months 2. Cost-effectiveness outcome measure: costs will be determined for the health service following discussions with key relevant dental and finance staff where time taken for treatments, clinic and staff involvement, materials and equipment used will be logged and costed (using published unit costs) to determine costs of treatment for each technology. The costs for children and their families will be determined by an analysis of questionnaires completed during the treatment phase. The costs to participating schools will be derived via questions in the semi-structured interviews conducted with staff from participating schools. In terms of outcomes the indicators of effect for clinical effectiveness will be used along with costs to estimate the relative cost-effectiveness of the two approaches. In addition, utility values will be measured as Quality Adjusted Tooth Years (QATYs), which is the production of additional years of life (tooth-year) of each tooth adjusted for the quality of the tooth. An unrestored tooth has a QATY equal to 1 in the year that it was restoration-free, while a restored, crowned, or root canal treated tooth has a QATY less than perfect (i.e., less than 1) in the year that it was restored and subsequent years. The QATY for an extracted tooth is equal to 0 in that year and subsequent years. 3. Health related quality of life scores will be calculated at entry, 12 months, 24 months and 36 months. These scores will be mapped onto utility scores to generate QALYs. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Patient acceptability, measured using a modified version of the Delighted-Terrible Faces Scale. This will be triangulated via a series of semi-structured interviews with parents/school staff/clinical personnel on treatment acceptability 2. During the clinical placement of the technologies under investigation, we will record the following indicators of patient acceptability/adverse outcomes: 2.1. Vomiting 2.2. Crying 2.3. Gagging 2.4. Excessive arm/leg movements 2.5. Other signs of distress | — |
Countries
United Kingdom
Outcome results
None listed