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Trial registered on ANZCTR


Registration number
ACTRN12612000630819
Ethics application status
Approved
Date submitted
11/06/2012
Date registered
12/06/2012
Date last updated
12/06/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Interappointment pain experience with a new endodontic medicament: a randomised controlled trial
Scientific title
Comparison of Odontocide with calcium hydroxide paste for interappointment pain in patients undergoing endodontic treatment
Secondary ID [1] 280528 0
Nil
Universal Trial Number (UTN)
U1111-1130-9558
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Apical periodontitis 286526 0
Pulpal inflammation 286585 0
Condition category
Condition code
Inflammatory and Immune System 286861 286861 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 286978 286978 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 284972 0
Treatment: Drugs
Comparator / control treatment
Calcium hydroxide paste
Dose of approximately 0.5mL (20% calcium hydroxide) 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.
Control group
Active

Outcomes
Primary outcome [1] 287217 0
Interappointment pain.
A visual analogue scale (VAS) will be used for the patient to report the level of pain (if any) they are experiencing at the respective time point. The patient will make one mark along the 10cm line indicating the level of pain they feel.
Timepoint [1] 287217 0
6, 24, 48, 72 and 96 hours after treatment
Secondary outcome [1] 297650 0
Need for rescue analgesia.
If the patient takes any rescue analgesic drugs, they will record on their recording sheet the analgesic drug, dose and time point(s) it was taken.
Timepoint [1] 297650 0
6, 24, 48, 72 and 96 hours after treatment

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All patients who fit the inclusion criteria and give consent to participating in the study will be allocated one of the two modalities as determined by a randomisation list determined prior to the study by a person not involved in administering the treatment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation with a random number generator.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285417 0
University
Name [1] 285417 0
The University of Melbourne
Country [1] 285417 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
Melbourne Dental School
720 Swanston St
Carlton VIC 3010
Country
Australia
Secondary sponsor category [1] 284268 0
Charities/Societies/Foundations
Name [1] 284268 0
Australian Society of Endodontology
Address [1] 284268 0
L 2 / 195 North Tce
Adelaide, SA 5000
Country [1] 284268 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287429 0
The University of Melbourne
Ethics committee address [1] 287429 0
Ethics committee country [1] 287429 0
Australia
Date submitted for ethics approval [1] 287429 0
Approval date [1] 287429 0
21/05/2012
Ethics approval number [1] 287429 0
1136566

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34207 0
Address 34207 0
Country 34207 0
Phone 34207 0
Fax 34207 0
Email 34207 0
Contact person for public queries
Name 17454 0
Associate Professor Peter Parashos
Address 17454 0
5th floor, 720 Swanston St
Carlton VIC 3010
Country 17454 0
Australia
Phone 17454 0
+61393411472
Fax 17454 0
Email 17454 0
[email protected]
Contact person for scientific queries
Name 8382 0
Dr Kehn Yapp
Address 8382 0
Postgraduate room 2,
5th floor, 720 Swanston St
Carlton VIC 3010
Country 8382 0
Australia
Phone 8382 0
+61393411230
Fax 8382 0
Email 8382 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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