Pulpotomy vs.Root Canal Treatment in Managing Irreversible Pulpitis

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.

Study Overview

• Status: Recruiting
• Conditions: Pulpitis - Irreversible
• Intervention / Treatment: Procedure: pulpotomy; Procedure: Root canal treatment

• Study Type: Interventional
• Enrollment (Anticipated): 168
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Liverpool, United Kingdom, L78XP
    • Active, not recruiting
    • Royal Liverpool University Hospital
  • London, United Kingdom, SE5 9RS
    • Recruiting
    • King's College Hospital
    • Contact: Francesco Mannocci; Phone Number: 02011881573; Email: francesco.mannocci@kcl.ac.uk
    • Sub-Investigator: Tiago Pimentel
  • London, United Kingdom, SE19RT
    • Recruiting
    • Guy's Hospital
    • Contact: Francesco Mannocci, Prof; Phone Number: 02011881573; Email: francesco.mannocci@kcl.ac.uk
    • Principal Investigator: Tiago Pimentel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• • 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.

Exclusion Criteria: Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: experimental pulpotomy	Procedure: pulpotomy; removal of the pulp from pulp chamber
Active Comparator: Root canal treatment	Procedure: Root canal treatment; Removal of at the entire content of the root canal system and root canal obturation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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.	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	12 months

Collaborators and Investigators

• Sponsor: King's College London

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Anticipated): April 1, 2023
• Study Completion (Anticipated): April 1, 2023

Study Registration Dates

• First Submitted: May 14, 2019
• First Submitted That Met QC Criteria: May 17, 2019
• First Posted (Actual): May 20, 2019

Study Record Updates

• Last Update Posted (Actual): November 12, 2020
• Last Update Submitted That Met QC Criteria: November 9, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Dental Pulp Diseases; Pulpitis
• Other Study ID Numbers: PB-PG-0817-20040

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No