SMART filling for caries in primary teeth
| ISRCTN | ISRCTN14233369 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14233369 |
| IRAS number | 253369 |
| Secondary identifying numbers | CPMS 38878, IRAS 253369 |
- Submission date
- 16/07/2018
- Registration date
- 26/07/2018
- Last edited
- 18/03/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Oral Health
Plain English Summary
Background and study aims
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 a poorer chance of successful repair and ultimately no option except complete tooth removal. A solution developed over the past decade is a new SMART 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 to assess restoration failure following 6 months placement of the SMART composite on minimally prepared cavities in children’s teeth.
Who can participate?
Children aged 6 to 12 with decayed primary teeth that require extraction (stage 1) or children aged 5 to 9 restoration (stage 2)
What does the study involve?
Children taking part in stage 1 have primary teeth decayed beyond repair that require extraction. The new filling material is placed in the affected tooth for the typical 4-week period between hospital appointments for consent and tooth extraction. Participants are followed up to confirm that the material remains in place to reduce pain and disease progression without any unforeseen side effects. In stage 2, children have their decayed primary molar teeth restored with the new composite. Restoration success is assessed at standard 12-month check-ups.
What are the possible benefits and risks of participating?
Children are set to benefit most if successful as at present thousands of children every year have general anaesthetics for dental treatment. Simplifying the procedure for filling decayed teeth and reducing failure rates will help decrease this number. This composite can be placed directly onto the child’s softened tooth without drilling, anaesthetic or current complex bonding procedures reducing time spent in the dental chair. This composite eliminates the need to place a mercury-containing restoration. The study will determine whether there are any side effects or reactions and prove the unique selling properties of the new material. While this specific composite is untested clinically, the main individual components are commonly used in dental composites that have been in clinical use for over 60 years. The two additional new components are added at low levels and used extensively at much higher levels in bone cements (MCPM) or as a preservative in food (polylysine). The filling material will only be placed in primary teeth which will ultimately fall out. The study has been designed to ensure all participants are exposed to minimum risk whilst confirming the safety and feasibility of the composite material.
Where is the study run from?
UCL Eastman Dental Institute (UK)
When is the study starting and how long is it expected to run for?
March 2018 to January 2026
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
Dr Paul Ashley, p.ashley@ucl.ac.uk
Contact information
Scientific
Paediatric Dentistry
UCL Eastman Dental Institute
256 Grays Inn Rd
London
WC1X 8LD
United Kingdom
Study information
| Study design | Non-randomized interventional study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific 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 |
| Study acronym | SMART |
| Study hypothesis | To ensure that the filling material does not compromise the clinical condition or safety of patients and users; that it achieves its intended purposes; that any risks associated are acceptable when weighed against the benefits to the patient and compatible with a high level of protection of health and safety. |
| Ethics approval(s) | 1. Approved 30/07/2018 Stage 1, London - Bloomsbury Research Ethics Committee (HRA RES Centre Manchester, 3rd Floor Barlow House, 4 Minshull Street, Manchester, M1 3DZ, UK; telephone unavailable; bloomsbury.rec@hra.nhs.uk), ref: 18/EE/0191 2. Approved 04/03/2022 Stage 2, London - Bloomsbury Research Ethics Committee (HRA RES Centre Manchester, 3rd Floor Barlow House, 4 Minshull Street, Manchester, M1 3DZ, UK; telephone unavailable; bloomsbury.rec@hra.nhs.uk), ref: 22/LO/0089 |
| Condition | Dental caries |
| Intervention | 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 or difficult placement of the new filling. After three months participants will be contacted by phone and asked about any adverse or unexpected events or reactions. After 12 months the fillings will be assessed to see if they are still in place. The children will be checked again for any unexpected or adverse events or reactions. Children who do not consent will have an ordinary filling placed in the normal way. Previous interventions: 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 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 place the new filling material placed in one tooth. Patients and carers will be asked to assess how easy or difficult placement of the new filling. After three months participants will be contacted by phone and asked about any adverse or unexpected events or reactions. After six months the fillings will be assessed to see if they are still in place. The children will be checked again for any unexpected or adverse events or reactions. Children who do not consent will have an ordinary filling placed in the normal way. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Renewal MI |
| Primary outcome measure | 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 outcome measures | 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) |
| Overall study start date | 01/03/2018 |
| Overall study end date | 01/01/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 5 Years |
| Upper age limit | 12 Years |
| Sex | Both |
| Target number of participants | 98 |
| Participant 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 |
| Participant 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 |
| Recruitment start date | 01/11/2022 |
| Recruitment end date | 01/01/2026 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
London
WC1E 6DG
United Kingdom
Sponsor information
University/education
Joint Research Office, UCL
Gower Street
London
WC1E 6BT
England
United Kingdom
"ROR" |
https://ror.org/02jx3x895 |
|---|
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 01/07/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Publications in peer reviewed journals and at relevant conferences. Information will also be displayed at the recruitment center for patients. |
| IPD sharing plan | The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 25/07/2018 | 02/04/2019 | No | No | |
| Other unpublished results | Sponsor stage 1 summary report | 20/10/2021 | 20/10/2021 | No | No |
| HRA research summary | 28/06/2023 | No | No | ||
| HRA research summary | 28/06/2023 | No | No |
Additional files
- ISRCTN14233369_PROTOCOL_25Jul18.docx
- Uploaded 02/04/2019
- ISRCTN14233369_Other unpublished results_20Oct21.pdf
- Sponsor stage 1 summary report
Editorial Notes
18/03/2025: The recruitment end date was changed from 01/01/2025 to 01/01/2026.
27/11/2023: The following changes were made to the study record:
1. The recruitment end date was changed from 01/11/2023 to 01/01/2025.
2. The overall study end date was changed from 01/01/2025 to 01/01/2026.
3. The intention to publish date was changed from 01/07/2025 to 01/07/2026.
24/10/2022: Ethics approval added.
20/10/2022: The following changes have been made:
1. The overall trial end date has been changed from 01/01/2024 to 01/01/2025 and the plain English summary updated accordingly.
2. The intention to publish date has been changed from 04/03/2025 to 01/07/2025.
19/10/2022: The following changes have been made:
1. The IRAS number has been added.
2. The intention to publish date has been changed from 01/07/2021 to 04/03/2025.
17/10/2022: The following changes have been made:
1. The recruitment start date has been changed from 01/04/2018 to 01/11/2022.
2. The recruitment end date has been changed from 01/06/2020 to 01/11/2023.
3. The phase has been added.
20/10/2021: An unpublished results document has been uploaded as an additional file
20/09/2021: Internal review.
26/08/2021: The following changes have been made:
1. The overall end date has been changed from 01/12/2021 to 01/01/2024.
2. The interventions have been updated.
3. The primary outcome measure has been updated.
4. The secondary outcome measures have been updated.
5. The participant inclusion criteria have been updated.
6. The target number of participants and total target enrolment have been changed from 66 to 98.
7. The plain English summary has been updated to reflect the changes above.
28/07/2020: The following changes were made to the trial record:
1. The overall end date was changed from 01/07/2020 to 01/12/2021.
2. The plain English summary was updated to reflect these changes.
25/07/2019: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/06/2019 to 01/06/2020.
2. The overall end date was changed from 01/07/2019 to 01/07/2020.
3. The intention to publish date was changed from 01/04/2020 to 01/07/2021.
4. The plain English summary was updated to reflect these changes.
25/04/2019: The condition has been changed from "Specialty: Oral and Dental Health, Primary sub-specialty: Paediatric Dentistry; UKCRC code/ Disease: Oral and Gastrointestinal/ Diseases of oral cavity, salivary glands and jaws" to "Dental caries" following a request from the NIHR.
08/04/2019: The following changes were made:
1. The recruitment end date was changed from 01/03/2019 to 01/06/2019.
2. The overall trial end date was changed from 01/04/2019 to 01/07/2019.
02/04/2019: Uploaded protocol (not peer reviewed).
08/01/2019: The following changes have been made:
1. The recruitment end date has been updated from 01/12/2018 to 01/03/2019.
2. The overall trial end date has been updated from 01/03/2019 to 01/04/2019.
3. The intention to publish date has been updated from 01/12/2019 to 01/04/2020.
