Condition category
Oral Health
Date applied
16/07/2018
Date assigned
26/07/2018
Last edited
25/07/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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 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 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 6 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 July 2020 (updated 25/07/2019, previously: March 2019)

Who is funding the study?
National Institute for Health Research (NIHR) (UK)

Who is the main contact?
Dr Paul Ashley

Trial website

Contact information

Type

Scientific

Primary contact

Dr Paul Ashley

ORCID ID

Contact details

Paediatric Dentistry
UCL Eastman Dental Institute
256 Grays Inn Rd
London
WC1X 8LD
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

38878

Study information

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

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

rref: 18/EE/0191 - approval pending

Study design

Non-randomised; Interventional; Design type: Treatment, Device

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Dental caries

Intervention

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

Phase

Drug names

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

Acceptability will be measured using a simple questionnaire at the end of stage 2 (6 months)

Overall trial start date

01/03/2018

Overall trial end date

01/07/2020

Reason abandoned (if study stopped)

Eligibility

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 type

Patient

Age group

Child

Gender

Both

Target number of participants

Planned Sample Size: 66; UK Sample Size: 66

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

01/04/2018

Recruitment end date

01/06/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

UCL Eastman Dental Institute
256 Grays Inn Rd
London
WC1X 8LD
United Kingdom

Sponsor information

Organisation

University College London

Sponsor details

Joint Research Office
UCL
Gower Street
London
WC1E 6BT
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

NIHR Central Commissioning Facility (CCF); Grant Codes: II-LB-0214-20002

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

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 statement
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.

Intention to publish date

01/07/2021

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

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.