Effects of the Application of a Hyper-oxygenated Gel After Oral Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-35
SponsorAzienda Ospedaliera di Perugia
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
diabetes mellitus;
systemic arterial hypertension;
hyperthyroidism;
osteoporosis;
Trial design
Design model
Parallel
Treatments tested in this trial
Hyper-oxygenated gel
Other interventionNovox 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
Other interventionThe placebo consists of a viscous, colorless and transparent gel, based on glycerin (Conformity:FUI).
Treatment groups
72 Participants
are divided into 2 treatment groupsGroup A: Hyper-oxygenated GelActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Masseteric trismus.
Masseteric trismus will be assessed by measuring the width of the mouth opening. Precisely, the distance in cm between the mesial corners of the incisal edges of the upper central incisors and the lower right incisors at maximum mouth opening, before surgery and on the seventh postoperative day, using a caliper. Measurements will be taken twice to determine the average score. The difference between the average of each postoperative measurement and the preoperative one will indicate the trismus for that day.
Time frame
seven daysSecondary outcomes
1
Post-operative pain
The intensity of postoperative pain will be assessed with a Visual Analog Scale (VAS). The patient will be able to express the degree of pain perceived at both time one and time two on a scale of ten intervals. Grade 1 on the scale indicates no pain, grade ten indicates very intense pain.
Time frame
seven days2
Facial swelling
The swelling of the face in cm will be determined by measuring the distance from the corner of the mouth to the attachment of the earlobe following the curvature of the cheek and the distance from the outer canthus of the eye to the corner of the jaw. The arithmetic mean of the two measurements will be considered as reference. The difference between each postoperative measurement and baseline will indicate facial swelling for that day.
Time frame
seven daysSponsors and contacts
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Source ClinicalTrials.gov