Not Yet RecruitingPhase 3ACTRN12612000630819

Interappointment pain experience with a new endodontic medicament: a randomised controlled trial

Comparison of Odontocide with calcium hydroxide paste for interappointment pain in patients undergoing endodontic treatment


Sponsor

The University of Melbourne

Enrollment

24 participants

Start Date

Jul 1, 2012

Study Type

Interventional

Conditions

Summary

A randomised controlled trial will be conducted on patients undergoing endodontic treatment in the Royal Dental Hospital of Melbourne. Two medicaments, placed inside the root canals of teeth, will be compared: Calcipulpe (calcium hydroxide paste) and Odontocide (calcium hydroxide and ibuprofen paste). Following treatment, patients will be required to record pain scores on a Visual Analogue Scale corresponding to specified times prior to and following treatment. If the amount of pain following treatment is severe enough, requiring the patient to take oral analgesics (rescue analgesia), then details regarding further drug administration will be recorded by the patient.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria2

  • Restorable teeth suitable for root canal treatment over multiple visits.
  • A coherent understanding of English so that explanations and instructions can be followed.

Exclusion Criteria7

  • Patients who cannot communicate in English
  • Visually impaired patients who cannot complete the pain recording sheet
  • Allergy to any of the medicament contents, including ibuprofen and other drugs in the same class (non steroidal anti-inflammatory drugs)
  • Asthmatic patients
  • Patients taking warfarin
  • Pregnant women
  • An eligible tooth where at least one other tooth in the same quadrant requires root canal treatment or removal

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Interventions

Odontocide (calcium hydroxide and ibuprofen) paste. Dose of approximately 0.5mL (20% calcium hydroxide and 7% ibuprofen) will be placed once, by the treating clinician inside the root canal(s) of the

Odontocide (calcium hydroxide and ibuprofen) paste. Dose of approximately 0.5mL (20% calcium hydroxide and 7% ibuprofen) will be placed once, by the treating clinician inside the root canal(s) of the treated tooth at the end of the first treatment appointment. Overall duration will be between 4 and 14 days, when it will be removed from the root canal to finish the treatment.


Locations(1)

Australia

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ACTRN12612000630819