Effects of the Application of a Hyper-oxygenated Gel After Oral Surgery
NCT ID: NCT06458478
Last Updated: 2024-06-13
Study Results
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Basic Information
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RECRUITING
NA
72 participants
INTERVENTIONAL
2024-07-01
2025-02-01
Brief Summary
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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).
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Hyper-oxygenated Gel
Patients undergoing lower third molar extraction. Post-operatively, the antibiotic (amoxicillin + clavulanic acid) and the painkiller (paracetamol 1000mg x 2 times a day x 7 days) are prescribed.
Furthermore, patients will have to use the Novox drop at the post-extraction site 3 times a day for 7 days (without taking liquids for 30 minutes after use).
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.
Placebo
Patients undergoing lower third molar extraction. Post-operatively, the antibiotic (amoxicillin + clavulanic acid) and the painkiller (paracetamol 1000 mg x 2 times a day x 7 days) are prescribed.
Furthermore, patients will have to use the Placebo, glycerin based gel, at the post-extraction site 3 times a day for 7 days (without taking liquids for 30 minutes after use).
glycerin based gel
The placebo consists of a viscous, colorless and transparent gel, based on glycerin (Conformity:FUI).
Interventions
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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.
glycerin based gel
The placebo consists of a viscous, colorless and transparent gel, based on glycerin (Conformity:FUI).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
35 Years
ALL
No
Sponsors
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Azienda Ospedaliera di Perugia
OTHER
Responsible Party
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Mitro Valeria
Principal Investigator
Principal Investigators
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Massimiliano Gilli, Dr
Role: PRINCIPAL_INVESTIGATOR
Azienda Ospedaliera Perugia
Locations
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Ospedale Santa Maria della Misericordia
Perugia, , Italy
Countries
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Central Contacts
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Facility Contacts
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References
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Kim HS, Noh SU, Han YW, Kim KM, Kang H, Kim HO, Park YM. Therapeutic effects of topical application of ozone on acute cutaneous wound healing. J Korean Med Sci. 2009 Jun;24(3):368-74. doi: 10.3346/jkms.2009.24.3.368. Epub 2009 Jun 12.
Valacchi G, Fortino V, Bocci V. The dual action of ozone on the skin. Br J Dermatol. 2005 Dec;153(6):1096-100. doi: 10.1111/j.1365-2133.2005.06939.x.
Bocci V. Biological and clinical effects of ozone. Has ozone therapy a future in medicine? Br J Biomed Sci. 1999;56(4):270-9.
Martinez-Sanchez G, Al-Dalain SM, Menendez S, Re L, Giuliani A, Candelario-Jalil E, Alvarez H, Fernandez-Montequin JI, Leon OS. Therapeutic efficacy of ozone in patients with diabetic foot. Eur J Pharmacol. 2005 Oct 31;523(1-3):151-61. doi: 10.1016/j.ejphar.2005.08.020. Epub 2005 Sep 29.
Montevecchi M, Dorigo A, Cricca M, Checchi L. Comparison of the antibacterial activity of an ozonated oil with chlorhexidine digluconate and povidone-iodine. A disk diffusion test. New Microbiol. 2013 Jul;36(3):289-302. Epub 2013 Jun 30.
Osunde OD, Saheeb BD. Effect of age, sex and level of surgical difficulty on inflammatory complications after third molar surgery. J Maxillofac Oral Surg. 2015 Mar;14(1):7-12. doi: 10.1007/s12663-013-0586-4. Epub 2013 Oct 1.
Amin MM, Laskin DM. Prophylactic use of indomethacin for prevention of postsurgical complications after removal of impacted third molars. Oral Surg Oral Med Oral Pathol. 1983 May;55(5):448-51. doi: 10.1016/0030-4220(83)90227-x.
Marques RV, Branco-de-Almeida LS, Marques DM, Oliveira IC, Mendes SJ, Rodrigues VP, Lopes FF. Effect of the intra-alveolar administration of dexamethasone on swelling, trismus, and pain after impacted lower third molar extraction: a randomized, double-blind clinical trial. Med Oral Patol Oral Cir Bucal. 2022 Jan 1;27(1):e51-e58. doi: 10.4317/medoral.24894.
Cinquini C, Marchionni S, Derchi G, Miccoli M, Gabriele M, Barone A. Non-impacted tooth extractions and antibiotic treatment: A RCT study. Oral Dis. 2021 May;27(4):1042-1051. doi: 10.1111/odi.13607. Epub 2020 Sep 4.
Olmedo-Gaya MV, Manzano-Moreno FJ, Munoz-Lopez JL, Vallecillo-Capilla MF, Reyes-Botella C. Double-blind, randomized controlled clinical trial on analgesic efficacy of local anesthetics articaine and bupivacaine after impacted third molar extraction. Clin Oral Investig. 2018 Dec;22(9):2981-2988. doi: 10.1007/s00784-018-2386-1. Epub 2018 Feb 15.
Hadad H, Santos AFP, de Jesus LK, Poli PP, Mariano RC, Theodoro LH, Maiorana C, Souza FA. Photobiomodulation Therapy Improves Postoperative Pain and Edema in Third Molar Surgeries: A Randomized, Comparative, Double-Blind, and Prospective Clinical Trial. J Oral Maxillofac Surg. 2022 Jan;80(1):37.e1-37.e12. doi: 10.1016/j.joms.2021.08.267. Epub 2021 Sep 6.
Other Identifiers
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CMF2
Identifier Type: -
Identifier Source: org_study_id
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