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

NCT06458478 | Recruiting

• 1 other identifier: CMF2
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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).

Conditions

Molar, Fourth; Extracting Own Teeth; Edema Face; Pain; Trismus

Keywords

dysodontiasis; third molar; oral surgery; edema; trismus; pain

Outcome Measures

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.

  seven days

Secondary Outcomes (2)

• Post-operative pain

  seven days

• Facial swelling

  seven days

Study Arms (2)

Hyper-oxygenated Gel

ACTIVE COMPARATOR

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).

Other: Hyper-oxygenated gel

Placebo

PLACEBO COMPARATOR

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).

Other: glycerin based gel

Interventions

Hyper-oxygenated gel OTHER

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.

Also known as: Novox drop

Hyper-oxygenated Gel

glycerin based gel OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azienda Ospedaliera di Perugia: lead

Study Sites (1)

Ospedale Santa Maria della Misericordia

Perugia, 06156, Italy

RECRUITING

Related Publications (11)

• 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.

  PMID: 19543419 BACKGROUND

• 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.

  PMID: 16307642 BACKGROUND

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

  PMID: 10795372 BACKGROUND

• 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.

  PMID: 16198334 BACKGROUND

• 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.

  PMID: 23912871 BACKGROUND

• 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.

  PMID: 25729220 BACKGROUND

• 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.

  PMID: 6575332 BACKGROUND

• 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.

  PMID: 34564685 BACKGROUND

• 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.

  PMID: 32790913 BACKGROUND

• 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.

  PMID: 29450738 BACKGROUND

• 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.

  PMID: 34656515 BACKGROUND

MeSH Terms

Conditions

Tooth, Supernumerary; Pain; Trismus; Edema

Condition Hierarchy (Ancestors)

Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spasm; Neuromuscular Manifestations; Nervous System Diseases

Study Officials

• Massimiliano Gilli, Dr

  Azienda Ospedaliera Perugia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

valeria mitro, Dr

CONTACT

+393494509722; valeria.mitro@ospedale.perugia.it

Massimiliano Gilli, Dr

CONTACT

+393200360473; massimiliano.gilli@ospedale.perugia.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 6, 2024
• First Posted: June 13, 2024
• Study Start: July 1, 2024
• Primary Completion: October 1, 2024
• Study Completion: February 1, 2025
• Last Updated: June 13, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)