This trial is active, not recruiting.

Condition dental caries
Treatments pit and fissure sealant of permanent molars, no sealant of permanent molars
Sponsor University of Birmingham
Collaborator Birmingham Dental Hospital
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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
All 'sealable' permanent molars will be sealed: Occlusal fissures and where appropriate, buccal pits (on lower molars) and palatal pits (on upper molars) will be sealed. If patient compliance is adequate, a resin based sealant will be used as the first choice material. The tooth is thoroughly cleaned, prepared with a special solution, and dried. The liquid sealant is then applied and allowed to set hard.
pit and fissure sealant of permanent molars
The tooth is thoroughly cleaned, prepared with a special solution, and dried. The liquid sealant is then applied and allowed to set hard
(Sham Comparator)
No molars will be sealed.
no sealant of permanent molars
No sealant applied to permanent molars.

Primary Outcomes

Caries incidence
time frame: 12 months

Eligibility Criteria

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)

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by University of Birmingham.