Acceptability of Treatments in the “Seal or Varnish?” Trial

Objectives: Objectives: The “Seal or Varnish” RCT investigated the effectiveness of fissure sealants (FS) versus fluoride varnish (FV) in the prevention of dental caries over 36 months. This work reports the acceptability of these technologies to participants, initially aged 6-7 years.

Methods: Methods: A mixed methods approach was adopted. Participants completed a “Delighted/Terrible Faces score” at each treatment visit. The treating dental hygienist and dental nurse recorded observed signs of distress. For a sub-sample, acceptability interviews were conducted with children in pairs, at first and final treatments.

Results: Results: At baseline children’s feelings of “sadness” were greatest in the FS group (49.2 vs 27.1%) OR 0.38 (95%CI 0.29-0.50, p< 0.001). Over time the proportion of children opting for the “neutral or sad” options reversed, at the 30 month visit the data were FS (16.8%) vs FV (40.7%). The proportion of children showing obvious signs of distress at baseline was low (97/468 in the FS group and 40/464 in the FV group). In both groups the most frequently encountered sign was “gagging” (8.4% FS and 3.5% FV). By final examination these figures were 1.4% and 1.7% respectively. The qualitative results demonstrated that taste (for both technologies) was the aspect of treatment most commonly raised by children. However, aspects of the environment in which the treatments were provided (mobile dental clinic) featured as prominently in the children’s narratives as their perceptions of the treatments received. Overall withdrawal from the trial was low (12 of 1016 randomised) – a further 169 were lost due to moving away.

Conclusions: Conclusions: Both technologies were acceptable to children at all stage of the trial and whilst this varied over time did not result in significant loss to follow-up.
Funding: This trial was funded by the UK National Institute for Health Research Health Technology Assessment Programme Ref: 08/104/04.