Pulpitis - IrreversibleNCT03956199
Pulpotomy vs.Root Canal Treatment in Managing Irreversible Pulpitis
A study testing pulpotomy and Root canal treatment in people with Pulpitis - Irreversible, run by King's College London at 3 sites in United Kingdom.
Trial summary
The study aims to compare two methods of repairing and saving a badly damaged or infected tooth. One method is called root canal treatment (RoCT) and the other (new method) is called pulpotomy. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulpitis - Irreversible
- What is being tested?
- pulpotomy and Root canal treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 1 Sep 2019to 1 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- • Dental patients from an acute (secondary care) setting from at least three UK centres (including King's College London Dental Institute, Denmark Hill and Liverpool).
- Male or female (aged >16) able to provide informed consent in otherwise good general health with at least one molar tooth with clinical symptoms of irreversible pulpitis caused by caries, requiring RoCT (endodontic treatment).
- Patients enrolled will have clinical symptoms of irreversible pulpitis who need treatment.
Who cannot join
- The presence of fistulas or swelling
- Anterior teeth or premolars
- External or internal root resorption
- Multiple teeth with carious lesions in the same quadrant,
- Pregnant women, in view of requirements for radiographs.
- Patients younger than 16.
Show all 10Show fewer
- Patients unable to give consent.
- Patients who have been administered antibiotics in the previous month.
- Immunocompromised patients
- Teeth with hopeless prognosis with caries extended into root dentine and with tooth margin at crestal bone level
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites, 2 recruiting
- Active, not recruiting
Royal Liverpool University Hospital
Liverpool, L78XP
- Recruiting
Guy's Hospital
London, SE19RT
Francesco Mannocci, Prof, 02011881573, francesco.mannocci@kcl.ac.uk
Tiago Pimentel
- Recruiting
King's College Hospital
London, SE5 9RS
Francesco Mannocci, 02011881573, francesco.mannocci@kcl.ac.uk
Tiago Pimentel
About this study
Official title: Managing Irreversible Pulpitis - The Effectiveness of Pulpotomy Compared to Root Canal Treatment as a Replacement for Conventional Root Canal Treatment: A Multicentre Randomized Controlled Trial
The study aims to compare two methods of repairing and saving a badly damaged or infected tooth. One method is called root canal treatment (RoCT) and the other (new method) is called pulpotomy. RoCT involves removing the damaged area of the tooth including the tooth nerve (called the pulp), cleaning, disinfecting and sealing it. Pulpotomy however attempts to preserve as much of the tooth nerve as possible (keeping the tooth alive). RoCT is more expensive and painful. Therefore, some patients delay or avoid getting treated, resulting in later complications treated in an emergency setting. This research will aim to show that pulpotomy is less painful, less involved (i.e. less invasive), less time consuming and consequently more cost effective. Long term costs of dental treatment as well as the improved quality of life will therefore offer benefits for patients, public and the NHS who use dental services. Caries (tooth decay) is the most common diseases in the world. The NHS spends at least £3.4 billion per year on dental visits or at dental hospitals. This does not include private (societal) costs to individuals who do not qualify for NHS dental treatment. Consequently, those who end up avoiding or delaying treatment result in complications often treated through the NHS. We have therefore chosen a randomized controlled trial design, a gold standard method to compare the effectiveness of the two treatment options. The participants will be 168 dental patients (male or female) from different parts (London and Liverpool) of the UK so that results can be generalized. This design was considered in consultation with a member of the public (a co-applicant) who will be involved in the trial from the start to completion. The results will be published and discussed at conferences as well as through our patient and public network.
- Conditions
- Pulpitis - Irreversible
- Being tested
- pulpotomy, Root canal treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pulpotomyProcedure or surgery
removal of the pulp from pulp chamber
Root canal treatmentProcedure or surgery
Removal of at the entire content of the root canal system and root canal obturation
| Study group | Role | What they receive |
|---|---|---|
| experimental pulpotomy | Experimental | Not described Receives: Procedure: pulpotomy |
| Root canal treatment | Active comparator | Not described Receives: Procedure: Root canal treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short term pain following pulpotomy versus root canal treatment
Pain, tenderness or swelling assessment at baseline and over the first 7 days post completion of treatment using a daily diary of pain (based on a 10 point visual analogue (VAS Scale), measured using the area under the curve (AUC) approach).
Measured: 7 days
Secondary outcomes (4)
Cost-effectiveness of pulpotomy
- Health care resource use between randomization and 12 months post randomization for assessing the cost-effectiveness of pulpotomy in comparison to RCT as measured by the incremental cost-effectiveness ratio (ICER) in terms of the INMB
Measured: 2 years
sensitivity and specificity of CBCT versus periodical radiographs to detect periapical radiolucencies
the sensitivity and specificity of periapical radiograph (clinical standard) to CBCT (experimental) in terms of detection of periapical disease.
Measured: 2 years
success rates of pulpotomy compared to root canal treatment
The vitality or absence of apical pathology of the tooth at 24 months: that is, an absence of either pain, swelling or tenderness to biting of the tooth and no evi-dence of inflammation in the tissues around the tip of the root detected by con-ventional radiographs and CBCT (independent assessors) after 24 months from randomisation. Both assessors must agree to conclude an overall absence of apical pathology. Treatment outcome will be assessed objectively using scans taken pre-treatment and and follow-up (6,12,24 months) appointments.
Measured: 2 years
Quality of life difference between patients that receive pulpotomy versus root canal treatment
- The EQ-5D-3L and EQ-5D-5L measured at baseline, over the first 7 days, 6 and 12 months post randomisation. One major feature of the EQ-5D tool is that the health states obtained from the questionnaire may be con-verted into a single index value with country specific value sets. This will facilitate the calculation and comparison of quality-adjusted life years (QALYs) between pulpotomy vs. primary root canal treatment. The QALY is a measure of disease burden including the quality and quantity of life lived, with one QALY equating to one year in perfect health
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2019
- Study start1 Sep 2019
- Primary completion1 Apr 2023 (estimated)
- Study completion1 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulpitis - IrreversibleStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03956199
- Sponsor's protocol ID
- PB-PG-0817-20040
- Status last verified
- Nov 2020
- First submitted
- 14 May 2019
- Last updated
- 12 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Patel N, Khan I, Jarad F, Zavattini A, Koller G, Pimentel T, Mahmood K, Mannocci F. The short-term postoperative pain and impact upon quality of life of pulpotomy and root canal treatment, in teeth with symptoms of irreversible pulpitis: A randomized controlled clinical trial. Int Endod J. 2025 Jan;58(1):55-70. doi: 10.1111/iej.14144. Epub 2024 Sep 26.
PubMed 39325552
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Managing Irreversible Pulpitis - The Effectiveness of Pulpotomy Compared to Root Canal Treatment as a Replacement for Conventional Root Canal Treatment: A Multicentre Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03956199
- Acronym / sponsor ID
- PB-PG-0817-20040
- Conditions
- Pulpitis - Irreversible
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Apr 2023 (estimated)
- Study completion
- 1 Apr 2023 (estimated)
- First posted
- 20 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to compare two methods of repairing and saving a badly damaged or infected tooth. One method is called root canal treatment (RoCT) and the other (new method) is called pulpotomy. RoCT involves removing the damaged area of the tooth including the tooth nerve (called the pulp), cleaning, disinfecting and sealing it. Pulpotomy however attempts to preserve as much of the tooth nerve as possible (keeping the tooth alive). RoCT is more expensive and painful. Therefore, some patients delay or avoid getting treated, resulting in later complications treated in an emergency setting. This research will aim to show that pulpotomy is less painful, less involved (i.e. less invasive), less time consuming and consequently more cost effective. Long term costs of dental treatment as well as the improved quality of life will therefore offer benefits for patients, public and the NHS who use dental services. Caries (tooth decay) is the most common diseases in the world. The NHS spends at least £3.4 billion per year on dental visits or at dental hospitals. This does not include private (societal) costs to individuals who do not qualify for NHS dental treatment. Consequently, those who end up avoiding or delaying treatment result in complications often treated through the NHS. We have therefore chosen a randomized controlled trial design, a gold standard method to compare the effectiveness of the two treatment options. The participants will be 168 dental patients (male or female) from different parts (London and Liverpool) of the UK so that results can be generalized. This design was considered in consultation with a member of the public (a co-applicant) who will be involved in the trial from the start to completion. The results will be published and discussed at conferences as well as through our patient and public network.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental pulpotomy | Experimental | Procedure: pulpotomy |
| Root canal treatment | Active comparator | Procedure: Root canal treatment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- • Dental patients from an acute (secondary care) setting from at least three UK centres (including King's College London Dental Institute, Denmark Hill and Liverpool).
Key exclusion criteria (10 listed)
- The presence of fistulas or swelling
- Anterior teeth or premolars
- External or internal root resorption
- Multiple teeth with carious lesions in the same quadrant,
- Pregnant women, in view of requirements for radiographs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pulpotomyremoval of the pulp from pulp chamber | Procedure or surgery | experimental pulpotomy |
| Root canal treatmentRemoval of at the entire content of the root canal system and root canal obturation | Procedure or surgery | Root canal treatment |
Primary outcome
Short term pain following pulpotomy versus root canal treatment
Time frame: 7 days
Pain, tenderness or swelling assessment at baseline and over the first 7 days post completion of treatment using a daily diary of pain (based on a 10 point visual analogue (VAS Scale), measured using the area under the curve (AUC) approach).
4 secondary outcomes
Cost-effectiveness of pulpotomy
Time frame: 2 years
sensitivity and specificity of CBCT versus periodical radiographs to detect periapical radiolucencies
Time frame: 2 years
success rates of pulpotomy compared to root canal treatment
Time frame: 2 years
Quality of life difference between patients that receive pulpotomy versus root canal treatment
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2020.
- Derived from this study: PubMed 39325552Patel N, Khan I, Jarad F, Zavattini A, Koller G, Pimentel T, Mahmood K, Mannocci F. The short-term postoperative pain and impact upon quality of life of pulpotomy and root canal treatment, in teeth with symptoms of irreversible pulpitis: A randomized controlled clinical trial. Int Endod J. 2025 Jan;58(1):55-70. doi: 10.1111/iej.14144. Epub 2024 Sep 26.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pulpotomy and Root canal treatment in people with Pulpitis - Irreversible, run by King's College London at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short term pain following pulpotomy versus root canal treatment (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03956199, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2020.