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Effects of the Application of a Hyper-oxygenated Gel After Oral Surgery
Sponsor: Azienda Ospedaliera di Perugia
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).
Official title: Effects of the Application of a Hyper-oxygenated Gel After Extraction of Impacted Lower Third Molars: Randomized Controlled Study
Key Details
Gender
All
Age Range
18 Years - 35 Years
Study Type
INTERVENTIONAL
Enrollment
72
Start Date
2024-07-01
Completion Date
2025-02-01
Last Updated
2024-06-13
Healthy Volunteers
No
Interventions
Hyper-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.
glycerin 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