Seal or Varnish? A comparison of the cost and effectiveness of sealants and varnish in preventing dental decay

• Register: ISRCTN
• Last refreshed on: 26 August 2019
• Main ID: ISRCTN17029222
• Date of registration: 21/10/2010
• Prospective Registration: Yes
• Primary sponsor: Cardiff University (UK)
• Public title: Seal or Varnish? A comparison of the cost and effectiveness of sealants and varnish in preventing dental decay
• Scientific title: A randomised trial to determine the relative cost and effectiveness of pit and fissure sealants and fluoride varnish in preventing dental decay
• Date of first enrolment: 01/06/2011
• Target sample size: 920
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN17029222
• Study type: Interventional
• Study design: Prospective two-arm randomised controlled trial (Treatment)
• Phase: Not Applicable

Countries of recruitment

United Kingdom

Contacts

• Name: Ivor Chestnutt

Key inclusion & exclusion 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:
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


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Dental caries
Oral Health
Dental caries

Intervention(s)

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.

1. Pit and Fissure Sealant (PFS):
Eligible study participants randomised to receive PFS will have PFS on all erupted and sound first permanent molars (FPM) at baseline. These will be applied by a dental hygienist according to conventional clinical protocol. These participants will be re-examined by the hygienist at six-monthly intervals and sealant retention checked and reapplied/topped up if deficient.

2. Fluoride Varnish (FV):
Eligible study participants randomised to receive FV (22,600 ppm F) will have FV applied to all partially erupted, erupted and sound FPMs at baseline. These will be applied by a dental hygienist according to a conventional clinical protocol. These participants will be re-examined by the hygienist at six-monthly intervals and FV reapplied to all FPMs.

The proposed duration for both PFS and FV treatment is three years. The proposed frequency and duration of follow up is 3 years post-baseline assessment. Sealant check and varnish application will take place at six-monthly intervals and clinical examinations (recording of caries status) will take place yearly (month 12, 24 and 36) post-treatment.

Primary Outcome(s)

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 Outcome(s)

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

Secondary ID(s)

2010-023476-23

HTA 08/104/04; SPON766-09

Source(s) of Monetary Support

Health Technology Assessment Programme

Ethics review

Status:
Approval date:
Contact:

Pending at time of registration

Results

• Results available: Yes
• Date Completed: 21/12/2015