Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001167156
Ethics application status
Approved
Date submitted
15/04/2019
Date registered
20/08/2019
Date last updated
22/03/2022
Date data sharing statement initially provided
20/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Topical Modification of Dental Pain and Movement
Scientific title
Use of Transient Receptor Potential (TRP) modulating topical cream in pain management following wisdom tooth extraction
Secondary ID [1] 297980 0
Nil known
Universal Trial Number (UTN)
Trial acronym
TRP - transient receptor potential
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain 312392 0
Widsom tooth removal 312417 0
Condition category
Condition code
Anaesthesiology 310950 310950 0 0
Pain management
Oral and Gastrointestinal 310978 310978 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
Topical application of 2.5g (half a teaspoon) of TRP modulating cream and 1mL of spray following wisdom tooth extraction to the jawline and external cheek at site of wisdom tooth extraction as required for up to five days.
Active ingredients are as follows:
a. Mentha Arvensis (Peppermint Oil)0.1%
b. Chamonilla Recutia (Matricaria) Flower oil 0.05%
c. Panax Ginseng Extract 5%
d. Aloe Vera powder 0.5%
e. Taurine 0.35%
f. Glycyrrhiza blabra (Liquorice extract)1%
g. Norhydroguiaretic acid 3%
h. Epigallocatechin3gallate
(EGCG) (Green Tea)0.05%
These are compounded with 25% glycerol.
Intervention code [1] 314198 0
Treatment: Drugs
Comparator / control treatment
Glyerol cream.
Control group
Placebo

Outcomes
Primary outcome [1] 319760 0
Pain will be assessed using a 10 point Likert scale, where patients grade their pain from 0 (no pain) to 10 (worst possible pain).
Timepoint [1] 319760 0
Day 1, 2, 3, 4 and 5 (primary timepoint).
Primary outcome [2] 319823 0
Maximal mouth opening.

This will be measured by the patient opening their mouth to its maximal capacity and using a cardboard ruler (provided to the patient) to measure the maximal width.
Timepoint [2] 319823 0
Day 1, 2, 3, 4, 5 (primary timepoint).
Secondary outcome [1] 369439 0
Medication use for analgesia following wisdom tooth extraction. This will be assessed using a study-specific questionnaire requiring a list of additional pain relief used following wisdom tooth surgery and any regular analgesia e.g. that required for other medical conditions.
Timepoint [1] 369439 0
Day 1, 2, 3, 4 and 5.

Eligibility
Key inclusion criteria
Patients undergoing bilateral wisdom tooth extraction, 14 years and over.
Minimum age
14 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with an intolerance to the spray, allergic reaction to spray/placebo ingredients, intellectually disabled participants and persons that speak languages other than English.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/10/2021
Actual
1/10/2021
Date of last participant enrolment
Anticipated
30/06/2022
Actual
Date of last data collection
Anticipated
7/07/2022
Actual
Sample size
Target
60
Accrual to date
60
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 22001 0
Tweed Day Surgery - Tweed Heads
Recruitment postcode(s) [1] 37104 0
2485 - Tweed Heads

Funding & Sponsors
Funding source category [1] 302503 0
Self funded/Unfunded
Name [1] 302503 0
Professor Peter Smith
Country [1] 302503 0
Australia
Primary sponsor type
Individual
Name
Professor Peter Smith
Address
Queensland Allergy Specialists
123 Nerang St, Southport, Queensland 4215
Country
Australia
Secondary sponsor category [1] 302411 0
None
Name [1] 302411 0
Address [1] 302411 0
Country [1] 302411 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303159 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 303159 0
Parklands Dr, Southport QLD 4215
Ethics committee country [1] 303159 0
Australia
Date submitted for ethics approval [1] 303159 0
05/07/2019
Approval date [1] 303159 0
26/03/2021
Ethics approval number [1] 303159 0

Summary
Brief summary
Wisdom tooth extraction often causes significant local tissue injury in a highly innervated area. This results in significant pain and loss of function. Reduced ability to open the jaw often also accompanies pain and lasts for several days. Dental nerves can express TRPV1, TRPA1 and TRPM3 and are known in allergy work to cause pain when stimulated by inflammatory mediators.
Two products, a spray and cream, have been developed that target these receptors via a topical approach. This study will assess pain and mobility after a reproducible "injury" following wisdom teeth surgery, compared to placebo.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 92686 0
Prof Peter Smith
Address 92686 0
Queensland Allergy Specialists
123 Nerang St, Southport, Queensland 4215
Country 92686 0
Australia
Phone 92686 0
+61 0755915744
Fax 92686 0
Email 92686 0
pksm@mac.com
Contact person for public queries
Name 92687 0
Prof Peter Smith
Address 92687 0
Queensland Allergy Specialists
123 Nerang St, Southport, Queensland 4215
Country 92687 0
Australia
Phone 92687 0
+61 07 5591 5744
Fax 92687 0
Email 92687 0
pksm@mac.com
Contact person for scientific queries
Name 92688 0
Prof Peter Smith
Address 92688 0
Queensland Allergy Specialists
123 Nerang St, Southport, Queensland 4215
Country 92688 0
Australia
Phone 92688 0
+61 07 5591 5744
Fax 92688 0
Email 92688 0
pksm@mac.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying published results only
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
Anyone who wishes to access it and has access to the publication journal
Available for what types of analyses?
For any purpose
How or where can data be obtained?
Access subject to approvals by Principal Investigator (email will be provided; pksm@mac.com)


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.