SMART filling for caries in primary teeth

Phase 2

• Conditions: Dental caries; Oral Health

• Registration Number: ISRCTN14233369
• Lead Sponsor: niversity College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-07-26
• Last Update Posted: 12 December 2023
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 98

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Current primary outcome measure as of 26/08/2021:<br> 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)<br> 2. Restoration failure assessed through examination at 12 months<br><br><br> Previous primary outcome measure:<br> 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)<br> 2. Restoration failure assessed through examination at 6 months<br>

Secondary Outcome Measures

Name	Time	Method
<br> Current secondary outcome measures as of 26/08/2021:<br> Acceptability will be measured using a simple questionnaire at the end of stage 2 (12 months)<br><br> Previous secondary outcome measures:<br> Acceptability will be measured using a simple questionnaire at the end of stage 2 (6 months)<br>