The Use of Pit and Fissure Sealants in Children Requiring Caries Related Dental Extractions
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      The purpose of thus study is to assess the feasibility and inform the planning of a proposed
      definitive randomised controlled clinical trial to investigate the efficacy of sealing
      permanent molars in children requiring caries related extractions under a chair General
      Anaesthetic.
    

Detailed description: 
      Objective:

      To evaluate,

        1. The ability to recruit based on failure to meet exclusion criteria, declining to
           participate or other reasons and retention rates based on subsequent withdrawals.

        2. Feasibility and acceptability of placing sealants in this setting, based on compliance
           with the intervention.

        3. Sealant retention rates based on the proportion of sealants that were fully intact,
           partially intact or lost after 24 months.

        4. Two-year incidence of caries in permanent molars that were sound and suitable for
           sealants at the time of the pre-GA assessment, based on the proportion of children with:

             1. Experience of caries into dentine in at least one permanent molar

             2. Untreated caries into dentine in at least one permanent molar

        5. Oral health related Quality of Life (OHRQoL) two years following caries related
           extractions under GA, based on the Child-Oral Impacts on Daily Performances (Child-OIDP)
           scale and separate questions relating to specified oral symptoms.

        6. Oral health support provided by referring practitioners, within the 2 years following
           the dental GA, based on,

             1. Structured interview questionnaire to record parents' experience of preventive
                advice and treatment received, following the GA extractions

             2. Sealants identified at follow up that were not present at baseline or provided as
                part of the study

      Recruitment and randomisation:

      Recruitment was carried out over a total period of 8 months. However, during this time, the
      study investigator (AR) was only available to recruit participants on ad hoc dates.
      Therefore, to facilitate recruitment, referral letters were triaged to identify children that
      were likely to be eligible (based on age, postcode and reason for GA referral) so they could
      be scheduled on these dates.

      Study information (including separate leaflets for parents and children) was posted a few
      weeks before the GA assessment appointment.

      At this visit, clinicians responsible for completing the GA assessment, also screened
      children to identify those that had potentially sealable permanent molars, and they were then
      invited to see the investigator on the same day. Further to this, eligibility to take part in
      the study, based on the full list of inclusion criteria was confirmed following full verbal
      and written consent.

      Results:

      Although the recruitment period extended over 8 months, as explained earlier, the study
      investigator was only available to undertake enrolment on a limited number of ad hoc sessions
      throughout this time. Based on these, 132 children were assessed for eligibility.
    

Intervention name(s): Pit and Fissure Sealant of permanent molars; No sealant of permanent molars
Intervention type(s): Procedure; Procedure
Intervention description(s): The tooth is thoroughly cleaned, prepared with a special solution, and dried. The liquid sealant is then applied and allowed to set hard; No sealant applied to permanent molars.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment