Birmingham Dental Hospital
Birmingham, United Kingdom
NCT Number: NCT02443896
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.
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Notify Me5 year–15 year
All sexes
Interventional
Not applicable
Birmingham, United Kingdom
Objective:
To evaluate,
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients who at the pre-General Anaesthetic assessment visit present with:
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.
Time frame: 12 months
The incidence of dental caries in permanent molars will be recorded.
University of Birmingham
Other
A Pilot Study to Investigate the Use of Pit and Fissure Sealants in Children Requiring Caries Related Dental Extractions Under a Chair General Anaesthetic
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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