The Use of Pit and Fissure Sealants in Children Requiring Caries Related Dental Extractions
This trial is active, not recruiting.
|Treatments||pit and fissure sealant of permanent molars, no sealant of permanent molars|
|Sponsor||University of Birmingham|
|Collaborator||Birmingham Community Healthcare NHS|
|Start date||April 2014|
|End date||April 2017|
|Trial size||100 participants|
|Trial identifier||NCT02443896, RG_14-089|
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.
|Intervention model||parallel assignment|
time frame: 12 months
Male or female participants from 5 years up to 15 years old.
Inclusion criteria - Children that are to have extraction of at least one carious tooth under a chair General Anaesthetic at Birmingham Dental Hospital - Birmingham residents (as indicated by post code of home address) - Be aged 5 to 15 years - Be co-operative to a clinical dental examination - Present with at least one permanent molar tooth that is 'sound and sealable' - Be accompanied by an adult that has legal capacity to give informed consent Exclusion criteria Patients who at the pre-General Anaesthetic assessment visit present with: - Signs of a systemic illness (e.g. coughs, 'colds', chicken pox) that might preclude placement of sealants - Oral symptoms (e.g. pain, swelling) that would preclude sealant placement - Parents unable to confirm (with a reasonable degree of certainty) that they would be contactable and able to attend for review during the 2 years duration of the study (e.g. because of plans to move)
|Official title||A Pilot Study to Investigate the Use of Pit and Fissure Sealants in Children Requiring Caries Related Dental Extractions Under a Chair General Anaesthetic|
|Principal investigator||Thomas Dietrich|
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