Clinical trial NCT06458478: Effects of the Application of a Hyper-oxygenated Gel After Oral Surgery
Official title: Effects of the Application of a Hyper-oxygenated Gel After Extraction of Impacted Lower Third Molars: Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Molar, Fourth
Extracting Own Teeth
Edema Face
Pain
Trismus
Keywords: dysodontiasis
third molar
oral surgery
edema
trismus
pain
Lead sponsor: Azienda Ospedaliera di Perugia
Sponsor class: OTHER
First posted: 2024-06-13
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Detailed description: 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.

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

The company producing Novox Drop will package both gels in opaque disposable syringes, identical from each other and distinguishable only by the presence of an "A" or "B" code. During the phases of the study, only the company will be aware which of the two codes will be associated with the medical device and which will be associated with the placebo. The patients to be subjected to the study will be obtained from those arriving at the maxillofacial surgery clinics for the surgical extraction of complex lower third molars, starting from July 2024 until the necessary sample size of 72 participants is reached. Each of them, who will be assigned a sequential numerical code, will be placed randomly (randomized) in one of the two arms of the study itself, group A or group B, using the Excel Microsoft 2015 system.

Patients in group A, in addition to the standard antibiotic therapy (amoxicillin + clavulanic acid 1 g x 3 times a day x 7 days) and painkiller (paracetamol 1000 mg x 2 times a day x 7 days) will be prescribed the home use of syringe A. Patients in group B, in addition to the aforementioned traditional therapy, the syringe B. The gel prescribed in both groups must be applied to the post-extraction site 3 times a day for 7 days. Furthermore, after each application of the gels, the patient cannot consume drinks and solid foods for 30 minutes.

The duration of the study will be one week, and will be divided into three visits:

the first at time 0 as soon as the surgery is finished where all the hygiene recommendations will be made, the basic therapy drugs (antibiotic and anti-inflammatory) will be prescribed, and the gels will be prescribed in the A or B syringes; the second visit at time 1 three days after the operation and the third visit at time 2 after a week in which the patient's health status will be assessed, the study data will be collected, the blisters of the therapy performed will be collected and the hygiene advice will be reiterated .

For the administration method just described, the study will be a triple blind study, where neither the patient, nor the prescribing doctor nor the observer of the results of the surgical wounds will be aware of the type of gel used. Only the doctor responsible for cataloging and processing complete with the results you will be aware of which gel was contained in syringe A and which in syringe B.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Masseteric trismus.
timeFrame: seven days
Secondary outcomes:
measure: Post-operative pain
timeFrame: seven days
measure: Facial swelling
timeFrame: seven days
Other outcomes:
Locations:
city: Perugia
country: Italy
facility: Ospedale Santa Maria della Misericordia
Study officials:
affiliation: Azienda Ospedaliera Perugia
name: Massimiliano Gilli, Dr
role: PRINCIPAL_INVESTIGATOR
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