Treatment preferences for irreversible pulpitis
| ISRCTN | ISRCTN75488545 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN75488545 |
| Integrated Research Application System (IRAS) | 343640 |
| Protocol number | 2-062-25 |
| Sponsor | University of Dundee |
| Funder | Royal College of Physicians and Surgeons of Glasgow |
- Submission date
- 13/04/2026
- Registration date
- 14/04/2026
- Last edited
- 13/04/2026
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
This study aims to help adults understand a dental problem called irreversible pulpitis and decide on their preferred treatment. Irreversible pulpitis is a painful condition where the inside of a tooth gets inflamed and can't heal on its own. Two different tools, called Patient Decision Aids, have been created to make it easier for patients to learn about this condition and make informed choices. One Patient Decision Aid includes health educational comics, while the other does not. These comics are designed to make the information more engaging and easier to understand.
Who can participate?
Adult patients attending routine appointments to the Dundee dental hospital.
What does the study involve?
Participants will be randomly assigned to use one of the two Patient Decision Aids. After using the Patient Decision Aid, they will fill out a questionnaire to see how well they understand the disease and if the information helps them decide on a treatment.
What are the possible benefits and risks of participating?
The results from the two groups will be compared to find out if the comics make a difference in helping patients understand irreversible pulpitis and make better treatment decisions.
There are no known risks of harm associated with participation in this study. Participants will be asked to review information and complete a small number of questionnaires. Participation is voluntary, and individuals may withdraw at any time without providing a reason by informing a member of the research team. Withdrawal will not affect current or future dental care or any future appointments at the Dental Hospital.
Where is the study run from?
Dundee Dental Hospital and Research School, University of Dundee, Scotland, UK.
When is the study starting and how long is it expected to run for?
May 2026 to January 2028.
Who is funding the study?
Royal College of Physicians and Surgeons of Glasgow, Scotland, UK.
Who is the main contact?
Dr Thibault Colloc, tcolloc001@dundee.ac.uk
Contact information
Principal investigator, Public, Scientific
Dundee dental hospital and Research school, University of Dundee
Dundee
DD1 4HR
United Kingdom
 ORCID ID |
0000-0001-9894-1666 |
|---|---|
| Phone | +441382385645 |
| tcolloc001@dundee.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Randomized controlled trial |
| Masking | Open (masking not used) |
| Control | Active |
| Assignment | Parallel |
| Purpose | Health services research |
| Participant information sheet | 49359_PIS_V2.0_07Jan2026.pdf |
| Scientific title | Treatment preferences for the management of irreversible Pulpitis (TIP): comparing two prototypes of a patient decision aid for shared decision making: a pilot randomised control study |
| Study acronym | TIP STUDY |
| Study objectives | To evaluate, in an adult population without the disease (Participants), the effectiveness of a PDA with health educational comics (Intervention) compared to a PDA without such comics (Control Comparator) in informing patients about irreversible pulpitis disease and its management and helping them prepare to make informed decisions for treatment (Outcomes). To achieve this, the patients consenting to take part will be randomised to one PDA or the other and will complete a validated questionnaire exploring the acceptability of the PDA, their understanding of the disease and whether the information provided would help them make a decision for treatment (Statistical Design). |
| Ethics approval(s) |
Approved 16/01/2026, London - Bromley Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 0207 104 8000; bromley.rec@hra.nhs.uk), ref: 25/PR/1635 |
| Health condition(s) or problem(s) studied | Management of severe or irreversible pulpitis |
| Intervention | Two patient decision aids (PDA) were co-designed to help patients with decision-making about the management of irreversible pulpitis in permanent teeth. Both PDAs include the same information, except one of the PDA includes a health education comics, whereas the other one does not. The method of randomisation uses an external randomisation software platform called “Sealed envelopes” (https://www.sealedenvelope.com/). Participants will be allocated to one PDA or the other with 1:1 randomisation allocation. Once the participants have had the opportunity to read the allocated PDA, they will be asked to complete a questionnaire including a preparation for decision-making scale section (primary outcome) and a knowledge and acceptability section (secondary outcomes). |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) |
|
| Completion date | 07/01/2028 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 120 Years |
| Sex | All |
| Target sample size at registration | 120 |
| Key inclusion criteria | 1. Adult patients (18 years and older) 2. Able to consent 3. Attending for routine or new patient appointments at the Dundee Dental Hospital and Research School |
| Key exclusion criteria | 1. Patients attending with emergency treatment needs (e.g. pulpitis, pain, infection) 2. Unable to read and/or understand written English |
| Date of first enrolment | 05/05/2026 |
| Date of final enrolment | 05/05/2027 |
Locations
Countries of recruitment
- United Kingdom
- Scotland
Study participating centre
Dundee
DD1 4HR
Scotland
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 2.0 | 07/01/2026 | 13/04/2026 | No | Yes |
| Protocol file | version 2.0 | 07/01/2026 | 13/04/2026 | No | No |
Additional files
- 49359_PIS_V2.0_07Jan2026.pdf
- Participant information sheet
- 49359_Protocol_v2.0_07Jan2026.pdf
- Protocol file
Editorial Notes
13/04/2026: Study's existence confirmed by Health Research Authority (HRA) (UK).
