Pulpotomy for Irreversible Pulpitis (PIP Trial) – Feasibility Study
Research type
Research Study
Full title
Pulpotomy for the management of irreversible pulpitis in mature teeth
IRAS ID
289464
Contact name
J E Clarkson
Contact email
Sponsor organisation
University of Dundee
ISRCTN Number
ISRCTN17973604
Duration of Study in the UK
4 years, 0 months, 30 days
Research summary
The PIP feasibility study will assess the 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 premolar or molar teeth in adults with symptoms indicative of irreversible pulpitis.
The feasibility study has five main objectives:
1. To identify training needs of GDPs to undertake an FP. An assessment of current general practice and training will be undertaken to determine the level of additional training required for a practising GDP to deliver a FP (which is currently not routinely delivered in practice).
2. To develop a clinical training package for study GDPs. Once the training requirements have been established, a full training package will be developed to facilitate the necessary theoretical and hands-on training to all GDPs participating in the study.
3. To assess if the intervention can be optimally delivered in routine NHS practice. Once trained, the GDPs participating in the feasibility study will perform FPs in practice on NHS patients who meet the clinical inclusion criteria and consent to take part. The delivery of the FP will be assessed for clinical accuracy and pragmatic practice adoption.
4. To estimate the number of eligible patients per practice for the main trial. In the process of screening NHS patients who are eligible to receive the FP treatment, participating GDPs will assess and extrapolate whether the number of participants required for the main trial can be reasonably recruited within the proposed time and resource parameters.
5. To develop recruitment materials for the main trial accounting for patient and dentist views. These materials will be developed, reviewed, and tested throughout the course of the feasibility study to test their effectiveness for the main trial.REC name
West of Scotland REC 5
REC reference
21/WS/0023
Date of REC Opinion
23 Feb 2021
REC opinion
Favourable Opinion