Dental caries Oral Health
Conditions
Interventions
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
Sponsors
University College London
Eligibility
Sex/Gender
All
Age
5 Years to 12 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 26/08/2021: 1. Safety will be assessed through examination at month 1 in the stage 1 of the study. In stage 2 it will be assessed by a phone conversation in at 3 months in stage 2 and at the end by examination (12 months) 2. Restoration failure assessed through examination at 12 months Previous primary outcome measure: 1. Safety will be assessed through examination at month 1 in the stage 1 of the study. In stage 2 it will be assessed by a phone conversation in at 3 months in stage 2 and at the end by examination (6 months) 2. Restoration failure assessed through examination at 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 26/08/2021: Acceptability will be measured using a simple questionnaire at the end of stage 2 (12 months) Previous secondary outcome measures: Acceptability will be measured using a simple questionnaire at the end of stage 2 (6 months) | — |
Countries
England, United Kingdom
Outcome results
None listed