RecruitingNot ApplicableNCT06458478

Effects of the Application of a Hyper-oxygenated Gel After Oral Surgery

Effects of the Application of a Hyper-oxygenated Gel After Extraction of Impacted Lower Third Molars: Randomized Controlled Study


Sponsor

Azienda Ospedaliera di Perugia

Enrollment

72 participants

Start Date

Jul 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to evaluate whether the topical application of Novox® Drop on surgical wounds after the extraction of lower third molars can have a clinical advantage. The primary objective of the study is to evaluate the possible reduction of masseteric trismus (masticatory muscle spasm - primary outcome) and of post-operative pain and facial edema (swelling - secondary outcomes) after the extraction of impacted third molars compared to those who do not use it (placebo=glycerin-based gel).


Eligibility

Min Age: 18 YearsMax Age: 35 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Hyper-oxygenated gel and glycerin based gel for people with edema face, extracting own teeth, and other related conditions. The study is currently recruiting participants at 1 location.

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

OTHERHyper-oxygenated gel

Novox drop is a medical device (CE certified, class II b, non-invasive) based on oxygen-enriched olive oil (Excipients: Mint essential oil (2%), Stevia extract (1%)). Mechanism of action: facilitate the healing process by creating, thanks to the release of reactive oxygen species (ROS), a microenvironment favorable to the activation of the microcirculation and at the same time unfavorable to the proliferation of pathogens. Furthermore, it has a film-forming, protective, barrier and soothing action thanks to its oily nature.

OTHERglycerin based gel

The placebo consists of a viscous, colorless and transparent gel, based on glycerin (Conformity:FUI).


Locations(1)

Ospedale Santa Maria della Misericordia

Perugia, Italy

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NCT06458478


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