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

NCT06458478 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2024-06-13

No results posted yet for this study

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).

Conditions

  • Molar, Fourth
  • Extracting Own Teeth
  • Edema Face
  • Pain
  • Trismus

Interventions

OTHER

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.

OTHER

glycerin based gel

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

Sponsors & Collaborators

  • Azienda Ospedaliera di Perugia

    lead OTHER

Principal Investigators

  • Massimiliano Gilli, Dr · Azienda Ospedaliera Perugia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-01
Primary Completion
2024-10-01
Completion
2025-02-01

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06458478 on ClinicalTrials.gov