Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06458478
Status:
RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-06-06
Brief Title:
Effects of the Application of a Hyper-oxygenated Gel After Oral Surgery
Sponsor:
Azienda Ospedaliera di Perugia
Organization:
Azienda Ospedaliera di Perugia
Study Overview
Official Title:
Effects of the Application of a Hyper-oxygenated Gel After Extraction of Impacted Lower Third Molars Randomized Controlled Study
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 placeboglycerin-based gel
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 placeboglycerin-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 ConformityFUI
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 patients 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
The placebo consists of a viscous colorless and transparent gel based on glycerin ConformityFUI
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 patients 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None