Pulpotomy vs.Root Canal Treatment in Managing Irreversible Pulpitis

NCT03956199 | Unknown

• 1 other identifier: PB-PG-0817-20040
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 3

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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).

  7 days

Secondary Outcomes (4)

• Cost-effectiveness of pulpotomy

  2 years

• sensitivity and specificity of CBCT versus periodical radiographs to detect periapical radiolucencies

  2 years

• success rates of pulpotomy compared to root canal treatment

  2 years

• Quality of life difference between patients that receive pulpotomy versus root canal treatment

  12 months

Study Arms (2)

experimental pulpotomy

EXPERIMENTAL

Procedure: pulpotomy

Root canal treatment

ACTIVE COMPARATOR

Procedure: Root canal treatment

Interventions

pulpotomy PROCEDURE

removal of the pulp from pulp chamber

experimental pulpotomy

Root canal treatment PROCEDURE

Removal of at the entire content of the root canal system and root canal obturation

Root canal treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• King's College London: lead

Study Sites (3)

Royal Liverpool University Hospital

Liverpool, L78XP, United Kingdom

ACTIVE NOT RECRUITING

Guy's Hospital

London, SE19RT, United Kingdom

RECRUITING

King's College Hospital

London, SE5 9RS, United Kingdom

RECRUITING

Related Publications (1)

• 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.

  PMID: 39325552 DERIVED

MeSH Terms

Interventions

Pulpotomy

Intervention Hierarchy (Ancestors)

Endodontics; Dentistry

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2019
• First Posted: May 20, 2019
• Study Start: September 1, 2019
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2023
• Last Updated: November 12, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3)