A study of the feasibility of testing pulpotomy treatment for toothache in primary dental care
| ISRCTN | ISRCTN17973604 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17973604 |
| IRAS number | 289464 |
| Secondary identifying numbers | HTA - NIHR129230, IRAS 289464 |
- Submission date
- 15/01/2021
- Registration date
- 28/01/2021
- Last edited
- 09/10/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English Summary
Background and study aims
Severe toothache and pain can be caused by tooth decay. Tooth decay is very common. Where the tooth decay has spread deep into the nerve, this is usually treated by taking out the tooth or by root canal treatment. Root canal treatment removes all of the nerve from the tooth.
An alternative treatment for this kind of toothache is called a pulpotomy. A pulpotomy removes only the damaged part of the nerve, which can be a quicker and less invasive treatment. Pulpotomy is already used on children’s teeth and on adult teeth when they are being treated in dental hospitals. However, it is not yet routinely used on adult teeth in NHS dental practices.
The researchers are planning a large-scale study to compare pulpotomy treatment with root canal treatment in NHS dental practices. However, before they embark on a larger more expensive study, they will conduct a 12-month feasibility study. A feasibility study is a piece of research done before the main study to assess if the study can be done and to collect information, such as patients' and dentists' experiences of the pulpotomy treatment, that can be taken into account in planning the larger study.
The aim is to find out more about: how many patients might be eligible for pulpotomy treatment, how many patients might be interested in this treatment, how best to train dentists to deliver the pulpotomy treatment and the practicalities of running this kind of study in NHS dental practices.
Who can participate?
Patients from participating dental practices with toothache that needs treatment which would normally be done by root canal treatment or by taking the tooth out. Anyone over 16 who the dentist believes would be suitable for this treatment.
What does the study involve?
Dentists from 10 dental practices will be trained to deliver the pulpotomy treatment. Each participating dental practice will be asked to recruit four eligible patients to receive pulpotomy treatment on their tooth. The participant will be contacted by their preferred means around 7 days after their treatment to collect information about their satisfaction with the pulpotomy treatment. Participants who have opted to take part in a telephone interview will be asked to talk about their experience of dental treatment in the study and their thoughts about the planned larger study. Participating dentists will also be asked to take part in telephone interviews to explore the appropriateness of the training, the feasibility of delivering the interventions and recruitment of participants to the trial.
What are the possible benefits and risks of participating?
Pulpotomy is a routine treatment carried out in dental hospitals for children and adults with toothache. There are very few risks to patients taking part. The pulpotomy treatment may be quicker and less invasive than other treatments such as root canal treatment and is an alternative to having an extraction. As with all treatments, there is a small risk that the treatment may not work, and the patient may require further treatment. This is also the case if they were to opt for a root canal treatment.
Where is the study run from?
Dundee Dental School (UK)
When is the study starting and how long is it expected to run for?
June 2020 to September 2022
Who is funding the study?
National Institute for Health Research Health Technology Assessment (NIHR HTA) Programme (UK)
Who is the main contact?
Dr Thibault Colloc, Clinical lecturer/Honorary specialty trainee in endodontology (Restorative Dentistry),
PIP-Study@dundee.ac.uk
Contact information
Public, Scientific
Clinical lecturer/Honorary specialty trainee in endodontology (Restorative Dentistry)
University of Dundee
Level 9
Dundee Dental School & Hospital
Park Place
Dundee
DD1 4HN
United Kingdom
 ORCID ID |
0000-0001-9894-1666 |
|---|---|
| Phone | +44 (0)1382 385645 |
| tcolloc001@dundee.ac.uk |
Study information
| Study design | Feasibility study for a multicentre randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Pulpotomy for the management of Irreversible Pulpitis in mature teeth - (PIP Trial) feasibility study |
| Study acronym | PIP Trial - Feasibility Study |
| Study hypothesis | The PIP feasibility study will assess the clinical and patient feasibility of conducting a pragmatic patient randomised controlled trial (PIP main trial). The main trial aims to evaluate the clinical and cost-effectiveness of a full pulpotomy (FP) procedure versus a root canal treatment (RCTx) for mature pre/molar teeth in adults with symptoms indicative of irreversible pulpitis. |
| Ethics approval(s) | Approved 09/03/2021, West of Scotland Research Ethics Committee 5 (West of Scotland Research Ethics Service, Ward 11, Dykebar Hospital, Grahamston Road, Paisley, PA2 7DE, UK; +44 (0)141 3140213; WoSREC5@ggc.scot.nhs.uk), ref: 21/WS/0023 |
| Condition | Tooth decay (irreversible pulpitis) in adult pre/molar teeth |
| Intervention | Dentists (GDPs) from 10 dental practices will be trained to deliver the pulpotomy treatment. Each participating dental practice will be asked to recruit 4 eligible patients to receive pulpotomy treatment on their tooth. The participant will be contacted by their preferred means around 7 days after their treatment to collect information about their satisfaction with the pulpotomy treatment. Participants who have opted to take part in a telephone interview will be asked to talk about their experience of dental treatment in the study and their thoughts about the planned larger study. Participating dentists will also be asked to take part in telephone interviews to explore the appropriateness of the training, the feasibility of delivering the interventions and recruitment of participants to the trial. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 1. Number of GDPs recruited to take part in the study by month 13 2. Proportion of GDPs recruited achieving success in pre-specified clinical criteria (access cavity preparation, adaption of the biodentine material, adequate final restoration) during their training 3. Proportion of radiographs that show compliance with intervention delivery using pre-specified clinical criteria by month 13 4. Proportion of patients satisfied with care measured using the Patient-Reported Experience Measures (PREMs) outlined in the NHS England Guide for Commissioning Dental Specialties (30) at up to 1-month post-intervention 5. Mean number of eligible patients per month by month 13 |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 01/06/2020 |
| Overall study end date | 30/09/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 16 Years |
| Sex | Both |
| Target number of participants | 40 |
| Total final enrolment | 25 |
| Participant inclusion criteria | Adults (16 years and older) with symptoms indicative of irreversible pulpitis [as defined by ESE (10)] in a pre/molar tooth with deep caries and or a deep restoration |
| Participant exclusion criteria | 1. Tooth with immature roots, clinical or radiographic signs of a necrotic pulp, or a poor prognosis (e.g. internal or external resorption) 2. Presence of a sinus, tenderness to percussion, buccal tenderness, pathological mobility or evidence of pathology on a periapical radiograph 3. Insufficient tooth tissue for a restoration 4. All treatment delivered under a private contract |
| Recruitment start date | 01/04/2021 |
| Recruitment end date | 30/09/2022 |
Locations
Countries of recruitment
- United Kingdom
Study participating centre
United Kingdom
Sponsor information
University/education
Tayside Medical Science Centre
Ninewells Hospital and Medical School
Dundee
DD1 4HN
Scotland
United Kingdom
| Phone | +44 (0)1382383297 |
|---|---|
| TASCgovernance@dundee.ac.uk | |
| Website | http://www.dundee.ac.uk/ |
"ROR" |
https://ror.org/03h2bxq36 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Health Technology Assessment Programme, HTA
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/09/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication of study protocol in a high-impact peer-reviewed journal |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 02/04/2022 | 04/04/2022 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
09/10/1024: The study contacts were changed.
13/09/2023: The intention to publish date has been changed from 30/09/2023 to 30/09/2024.
11/10/2022: The following changes have been made:
1. The recruitment end date has been changed from 08/10/2022 to 30/09/2022.
2. The intention to publish date has been changed from 08/10/2022 to 30/09/2023.
3. The overall trial end date has been changed from 30/06/2024 to 30/09/2022 and the plain English summary updated accordingly.
4. The final enrolment number has been added.
21/06/2022: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/06/2022 to 08/10/2022.
2. The intention to publish date was changed from 01/06/2022 to 08/10/2022.
3. The plain English summary was updated to reflect these changes.
04/04/2022: Publication reference added.
14/12/2021: The intention to publish date was changed from 01/06/2021 to 01/06/2022.
09/06/2021: The recruitment end date has been changed from 01/06/2021 to 01/06/2022.
13/04/2021: The ethics approval was added.
27/01/2021: Trial's existence confirmed by the NIHR.
