SMART filling for caries in primary teeth - Stage 2
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
253369
Contact name
Paul F Ashley
Contact email
ISRCTN Number
ISRCTN14233369
Duration of Study in the UK
2 years, 0 months, 3 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 now banned 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 this study is to assess percentage restoration failure following 12 months placement of SMART composite on minimally prepared cavities in children’s teeth. Children taking part in the clinical trial will have decayed primary molar teeth restored with the new composite. Restoration success will be clinically evaluated at standard 6 and 12 month check-ups.Lay summary of study results:
Because the lead researcher became unwell, the study had to stop early. By the time the study ended, 50 patients had reached visit 5. The other 15 patients had already dropped out or their fillings had already failed.At the 12‑month point (visit 5), 28 patients (56%) still had fillings that were fully intact. The remaining 22 patients (44%) had fillings that were no longer intact.
Because almost half of the fillings had failed by 12 months, the material did not perform well enough to support the original idea that it would work as intended.
Adverse events:
No serious problems were reported during the study.
Five teeth developed fractures in the outer walls of the tooth (either the cheek side or the palate side). These fractures were judged not to be caused by the filling material.Laboratory assessments:
None of the baby teeth that naturally fell out were returned to the research team, so the planned laboratory tests could not be done.REC name
London - Bloomsbury Research Ethics Committee
REC reference
22/LO/0089
Date of REC Opinion
4 Mar 2022
REC opinion
Further Information Favourable Opinion