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
Dental caries
Current interventions as of 26/08/2021: Stage 1 Potential participants will already be under treatment at the Eastman Dental Hospital for management of dental decay. These children will have decayed primary molar teeth that require extraction and will be aged between 6 and 12 years. During this appointment, parents/guardians and potential participants will have the study explained by a clinician, information pack will be given to both and they will be invited to take part. At the next visit after being invited to take part, children will be consented for entry into the study. Children who consent will have the new filling material placed in the tooth due for extraction. Additionally, patients will receive a telephone consultation following placement of the filling to ensure no adverse events or reactions had occurred. Parents/guardians and participants will also be supplied with contact information that will allow adverse events or reactions to be reported at any stage of the trial. Patients and carers will be asked to assess how easy or difficult placement of the new filling was. After 4 weeks participants will return for extraction of the tooth. They will be asked again about any adverse or unexpected events or reactions. Following extraction, participants will have no further involvement. Stage 2 Potential participants will already be under treatment at the Eastman Dental Hospital for management of dental decay. These children will have decayed primary molar teeth that require a filling and will be aged between 5 and 9 years. During this appointment, parents/guardians and potential participants will have the study explained by a clinician, information pack will be given to both and they will be invited to take part. At the next visit after being invited to take part children will be consented for entry into the study. Children who consent will have the place the new filling material placed in one tooth. Patients and carers will be asked to assess how easy o
Current participant inclusion criteria as of 26/08/2021: Stage 1: 1. Children 6 to 12 years of age 2. One primary molar with a carious cavity affecting one or more surfaces (International Caries Detection and Assessment System (ICDAS) score 4,5) that requires temporary dressing whilst awaiting extraction 3. Subject willing to sit in the dental chair and cooperate with clinicians on planned protocol treatment Stage 2: 1. Children 5 to 9 years of age 2. One primary molar with a two surface carious cavity (occlusal and proximal surface) ICDAS score 4,5 that requires restoration 3. Subject willing to sit in the dental chair and cooperate with clinicians on planned protocol treatment Previous participant inclusion criteria: Stage 1: 1. Children 6 to 12 years of age 2. One primary molar with a carious cavity affecting one or more surfaces (International Caries Detection and Assessment System (ICDAS) score 4,5) that requires temporary dressing whilst awaiting extraction 3. Subject willing to sit in the dental chair and cooperate with clinicians on planned protocol treatment Stage 2: 1. Children 6 to 12 years of age 2. One primary molar with a two surface carious cavity (occlusal and proximal surface) ICDAS score 4,5 that requires restoration 3. Subject willing to sit in the dental chair and cooperate with clinicians on planned protocol treatment
Stage 1: 1. Unable to give assent/consent 2. Non-carious anomaly of structure such as amelogenesis imperfecta 3. Patients with significant pain and/or infection who require an urgent management (assessed by standard clinical investigations) 4. Teeth with non-vital exposed pulps with draining pus (as per standard care) 5. Methacrylate allergy Stage 2: 1. Unable to give assent/consent 2. Non-carious anomaly of structure such as amelogenesis imperfecta 3. Subject NOT willing to sit in the dental chair and cooperate with clinicians on planned protocol treatment 4. Methacrylate allergy