SMART filling for caries in primary teeth
Research type
Research Study
Full title
SMART composite (Self-bonding Material for Atraumatic Restorative Treatment) restoration of children’s primary molar teeth after minimal caries removal: Class IIa device in a single site, single arm study.
IRAS ID
228909
Contact name
Paul F Ashley
Contact email
Sponsor organisation
UCL, Joint Research Office
Duration of Study in the UK
1 years, 3 months, 1 days
Research summary
Tooth decay affects 60 -90% of children worldwide. Treatment usually involves drilling to remove bacteria and underlying softened tooth before placement of a filling. For children, amalgam fillings are banned from next year in the EU due to global mercury toxicity concerns. Furthermore, in the UK, alternative white composite fillings are rarely applied in local dental practice due to the lengthy and complex placement procedures. Instead hospital admittance is required to enable general anaesthesia. Resultant treatment delays can lead to significant pain, larger holes with poorer chance of successful repair and ultimately no option except complete tooth removal.
Our solution, developed over the past decade, is a new composite that can be placed directly onto the child’s softened tooth structure without drilling, anaesthetic or current complex bonding procedures. The aim of the study is in the first stage to undertake a proof of concept and in the second stage assess percentage restoration failure following 6 months placement of SMART composite on minimally prepared cavities in children’s teeth.
Children taking part in stage one of the clinical trial will have primary teeth decayed beyond repair that require extraction. The new filling material will be placed in the affected tooth for the typical 4 week period between hospital appointment for consent and tooth extraction. Follow up will confirm the material remains in place to reduce pain and disease progression without any unforeseen side effects. In stage 2 of the trial, children between the ages of 6 and 12 will have decayed primary molar teeth restored with the new composite. Restoration success will be clinically evaluated at standard 6 month check-ups.
Clinical trial success would support application for CE marking, commercialisation, longer term trials and then placement by local dentists.REC name
East of England - Cambridge East Research Ethics Committee
REC reference
18/EE/0191
Date of REC Opinion
30 Jul 2018
REC opinion
Further Information Favourable Opinion