RecruitingPhase 3ACTRN12619001167156

Topical Modification of Dental Pain and Movement

Use of Transient Receptor Potential (TRP) modulating topical cream in pain management following wisdom tooth extraction


Sponsor

Professor Peter Smith

Enrollment

60 participants

Start Date

Oct 1, 2021

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 14 Yearss

Plain Language Summary

Simplified for easier understanding

Wisdom tooth extraction is a very common procedure, but it often causes significant pain, swelling, and difficulty opening the mouth for several days afterwards. The nerves involved in dental pain express specific receptors (TRPV1, TRPA1, TRPM3) that can be targeted with topical treatments. This study tests two topical products — a spray and a cream — that target these receptors, to see whether they can reduce pain and improve jaw mobility after wisdom tooth surgery compared to a placebo. Participants undergoing the removal of wisdom teeth on both sides of the mouth receive the topical products and are assessed for pain levels and how wide they can open their jaw in the days following surgery. The bilateral extraction design means the same person experiences the surgery on both sides, providing a useful comparison. You may be eligible if you are 14 or older and are scheduled to have both your left and right wisdom teeth removed. People with a known intolerance or allergy to the product ingredients, or who have intellectual disabilities or do not speak English, are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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 require

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.


Locations(1)

Tweed Day Surgery - Tweed Heads

QLD, Australia

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ACTRN12619001167156


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