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

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612000630819

Enrollment

Registered

2012-06-12

Start date

2012-07-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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 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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

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

Outcome results