Pulpotomy vs.Root Canal Treatment in Managing Irreversible Pulpitis

Last updated: November 9, 2020
Sponsor: King's College London
Overall Status: Active - Recruiting

Phase

N/A

Condition

Acute And Chronic Dental Pain

Treatment

N/A

Clinical Study ID

NCT03956199
PB-PG-0817-20040
  • Ages 18-75
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • • Dental patients from an acute (secondary care) setting from at least three UKcentres (including King's College London Dental Institute, Denmark Hill andLiverpool).
  • Male or female (aged >16) able to provide informed consent in otherwise goodgeneral health with at least one molar tooth with clinical symptoms ofirreversible pulpitis caused by caries, requiring RoCT (endodontic treatment).
  • Patients enrolled will have clinical symptoms of irreversible pulpitis who needtreatment.

Exclusion

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 toothmargin at crestal bone level

Study Design

Total Participants: 168
Study Start date:
September 01, 2019
Estimated Completion Date:
April 01, 2023

Connect with a study center

  • Royal Liverpool University Hospital

    Liverpool, L78XP
    United Kingdom

    Site Not Available

  • Guy's Hospital

    London, SE19RT
    United Kingdom

    Active - Recruiting

  • King's College Hospital

    London, SE5 9RS
    United Kingdom

    Active - Recruiting

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