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

Pain Trismus Edema Face Molar, Fourth Extracting Own Teeth

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

Inclusion Criteria5

good systemic and local health conditions of the patient;
age between 18 and 35 years;
understanding of the Italian language,
indications for the extraction of impacted bilateral lower third molars (38 and 48) according to the criteria reported in the classifications of Winter and that of Pell and Gregory;
the root of the impacted third molars is completely formed.

Exclusion Criteria11

diabetes mellitus;
systemic arterial hypertension;
hyperthyroidism;
osteoporosis;
immunosuppressed;
osteonecrosis of the jaws;
pregnancy;
patients with mandibular third molars in position C according to "the Pell \& Gregory Classification" on the radiological measurements (angles and positions) for which third molar extraction surgery is required.;
local alterations such as pericoronitis, odontogenic cysts and tumors in relation to the third molars;
allergies;
ordinary use of analgesics or antibiotics by the patient.

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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).