Exploration into families’ experience following a traumatic dental injury
| ISRCTN | ISRCTN14078645 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14078645 |
| IRAS number | 285158 |
| Secondary identifying numbers | IRAS 285158; UoL001608 |
- Submission date
- 15/06/2021
- Registration date
- 06/07/2021
- Last edited
- 28/05/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
The term 'traumatic dental injuries' (TDI) encompasses any injury to a tooth including fractures of the crown and/or root of the tooth, luxation injuries (a tooth that has moved position and been pushed sideways, into the gum or down), and avulsions (a knocked-out tooth).
TDIs are a common occurrence in children. The initial emergency care and advice provided are vital for the long-term survival of the tooth. The worse the tooth injury, the more important it is to receive appropriate management. Traumatised teeth also require careful follow-up, if the injury is not identified, diagnosed and managed in a timely manner, it decreases the prognosis of the tooth and can lead to tooth loss. Tooth loss not only has an effect on the child’s dentition and need for long-term replacement options but also has a huge effect on the child’s mental wellbeing. It is therefore imperative that families follow a clear pathway and receives the appropriate management in the appropriate place at the appropriate time. Unfortunately, despite professional guidelines on how to manage TDIs, there is evidence to suggest that there is a lack of both public and professional awareness of the optimal care pathway in the emergency management of such injuries.
The study aims to explore how the tooth injury happened, what happened after the injury, where did they decide to sought advice and management, and what urgent management was undertaken. Additionally, the study will explore what families felt went well, what did not go well, and what families would have liked to have happened following the tooth injury The study also aims to investigate what follow up management the child has received for the tooth injury and how COVID-19 has impacted the families’ experience of dental trauma management
Who can participate?
Children/young people aged 7-15 years who experienced dental trauma to a permanent (adult) tooth from January 2019 onwards, and their parent/guardian
What does the study involve?
Qualitative interviews with a family dyad including a child who has experience of dental trauma and an adult family member (parent/legal guardian), about their journey and experience following a traumatic dental injury (TDI). The interview will be held either face to face if restrictions allow, or virtually via a video platform. The child and their family member will be interviewed together by one researcher and there will be another researcher present as a chaperone for the interview who will remain silent. The interview is likely to take between 30-60 minutes. The interview will be audio-recorded and then transcribed. Both the child and their family member should be present throughout the interview and be able to hear all questions.
What are the possible benefits and risks of participating?
There is no direct benefit for taking part in the study. However, it could be an opportunity to share their experience and expertise in a way that can benefit others.
There are no perceived disadvantages or risks involved. The information that is given will be kept confidential, but the research team may have to pass on information in accordance with the local safeguarding policy if there is a concern for anyone’s safety and welfare.
Where is the study run from?
University of Liverpool (UK)
When is the study starting and how long is it expected to run for?
November 2020 to March 2022
Who is funding the study?
University of Liverpool (UK)
Who is the main contact?
Dr Nathalie Gallichan, ngalli@liverpool.ac.uk
Dr Laura Gartshore, lauramg@liverpool.ac.uk
Contact information
Public
Liverpool University Dental Hospital
Pembroke Place
Liverpool
L3 5PS
United Kingdom
 ORCID ID |
0000-0001-8722-889X |
|---|---|
| Phone | +44 (0)151 7065203 |
| ngalli@liverpool.ac.uk |
Scientific
Liverpool Dental Hospital
Pembroke Place
United Kingdom
L3 5PS
United Kingdom
| ORCID ID |
0000-0002-4272-5179 |
|---|---|
| Phone | +44 (0)151 7065203 |
| lauramg@liverpool.ac.uk |
Study information
| Study design | Qualitative interview study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Qualitative study |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact email ngalli@liverpool.ac.uk to request a participant information sheet |
| Scientific title | Qualitative semi-structured interviews to explore families’ experience following a traumatic dental injury |
| Study objectives | To explore families’ experience and their management pathway following a dental trauma injury |
| Ethics approval(s) | Approved 30/04/2021, HRA and Health and Care Research Wales (Health and Care Research Wales Support and Delivery Centre, Castlebridge 4, 15-19 Cowbridge Road East, Cardiff, CF11 9AB; no telephone number provided; HCRW.approvals@wales.nhs.uk), ref: 21/PR/0416 |
| Health condition(s) or problem(s) studied | Acute management of paediatric traumatic dental injuries |
| Intervention | Qualitative interviews with a family dyad including a child who has experience of dental trauma and an adult family member (parent/legal guardian), about their journey and experience following a traumatic dental injury (TDI). A topic guide has been developed and piloted. All interviews will be recorded with a digital voice recorder and transcribed to enable thematic framework analysis to be undertaken. Thematic analysis will be conducted using NVivo software. Key themes will be identified surrounding their experience, their thoughts on how their experience could have been improved and whether the impact of COVID affected their journey and experience. |
| Intervention type | Other |
| Primary outcome measure | Children’s experience of acute dental trauma management using qualitative semi-structured interviews with family dyads (consisting of a child and a family member) and thematic analysis at a single timepoint |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 28/11/2020 |
| Completion date | 03/03/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 7 Years |
| Upper age limit | 15 Years |
| Sex | Both |
| Target number of participants | 6-12 family dyads |
| Total final enrolment | 16 |
| Key inclusion criteria | 1. Children/young people aged 7-15 years who experienced dental trauma to a permanent (adult) tooth from January 2019 onwards 2. The child/young person lives with a parent/guardian who can consent, this adult does not have to have been present at the time of injury 3. The participant is able to communicate in spoken English 4. Minimum of 6 months between injury and date of recruitment |
| Key exclusion criteria | 1. Unable to speak English 2. Children under the age of 7 years or aged 16 years and older at the time of the TDI 3. Children in care who do not live with someone who can consent for them |
| Date of first enrolment | 01/06/2021 |
| Date of final enrolment | 24/02/2022 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Liverpool
L14 5AB
United Kingdom
Liverpool
L3 5PS
United Kingdom
Sponsor information
University/education
Clinical Directorate 4th Floor, Thompson Yates Building
Faculty of Health and Life Sciences
Liverpool
L69 3GB
England
United Kingdom
| Phone | +44 (0)151 7948739 |
|---|---|
| sponsor@liv.ac.uk | |
| Website | http://www.liv.ac.uk/ |
"ROR" |
https://ror.org/04xs57h96 |
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- The University of Liverpool, 利物浦大学, Universidad de Liverpool, UoL
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/09/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from either the PI/CI (ngalli@liverpool.ac.uk or lauramg@liverpool.ac.uk). Thematic analysis will be conducted using NVivo (© QSR International 2020) software. Key themes will be identified surrounding their experience, their thoughts on how their experience could have been improved, and whether the impact of COVID affected their journey and experience. These will be interpreted according, with the involvement of experienced topic and qualitative researchers. An independent researcher will also be involved to check the themes and data analysis and ensure that the CI has not over-represented some aspects of the data. Recordings will be kept until the end of the postgraduate studies. Transcripts and written data will be held securely on the password protected hard drive of the lead investigator for up to 10 years. Each participants/family will be assigned a pseudonym name during the transcription process. The PI will share the pseudonym with the CI/primary supervisor only. The pseudonym will be used on any transcripts sent to supervisors to discuss analysis and would be used pseudonym in all coding, themes and quotes in the final thesis/papers. All information will be stored on a password protected University computer in a locked office. Only the principal investigator and supervising team will be able to access and view the data. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 08/07/2021 | No | No | ||
| HRA research summary | 28/06/2023 | No | No | ||
| Basic results | 28/05/2024 | 28/05/2024 | No | No |
Additional files
- ISRCTN14078645_PROTOCOL.pdf
- Uploaded 08/07/2021
- ISRCTN14078645_BasicResults_28May24.pdf
Editorial Notes
28/05/2024: Basic results and total final enrolment added.
13/09/2023: The intention to publish date has been changed from 01/09/2023 to 01/09/2024.
08/03/2022: The following changes were made to the trial record:
1. The overall end date was changed from 03/09/2022 to 03/03/2022.
2. The recruitment end date was changed from 02/09/2022 to 24/02/2022.
3. The plain English summary was updated to reflect these changes.
08/07/2021: Uploaded protocol (not peer reviewed).
18/06/2021: Trial’s existence confirmed by HRA and Health and Care Research Wales.
