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

Pain Clinical Trial

Official title:

Effects of the Application of a Hyper-oxygenated Gel After Extraction of Impacted Lower Third Molars: Randomized Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06458478
• Other study ID #: CMF2
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: February 1, 2025

Study information

• Verified date: June 2024
• Source: Azienda Ospedaliera di Perugia
• Contact: valeria mitro, Dr
• Phone: +393494509722
• Email: valeria.mitro[@]ospedale.perugia.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: February 1, 2025
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Edema Face
• Pain
• Trismus

Intervention

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

Locations

Country	Name	City	State
Italy	Ospedale Santa Maria della Misericordia	Perugia

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera di Perugia

Country where clinical trial is conducted

Italy, 

References & Publications (11)

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. — View Citation

Bocci V. Biological and clinical effects of ozone. Has ozone therapy a future in medicine? Br J Biomed Sci. 1999;56(4):270-9. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	seven days
Secondary	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.	seven days
Secondary	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.	seven days