Efficacy of Ozone Therapy in Reducing Complications Following Impacted Mandibular Third-molar Surgery

NCT06802354 | Recruiting Phase 3 DMC

• 2 other identifiers: 01-2-919.032/961-110/23
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if use of ozone works to treat complications after impacted mandibular third molar surgery. It will also learn does ozone has positive effect on wound healing and quality of life. The main questions it aims to answer are:

• Does ozone reduce incidence of postoperative compliactions such as pain, swelling or reduced mouth opening after impacted mandibular third molar surgery?
• Does ozone improve wound healing after impacted mandibular third molar surgery?
• Does ozone have positive effect on quality of life after impacted mandibular third molar surgery? Participants will:
• Receive ozone after impacted mandibular third molar surgery.
• Visit the clinic 1st, 3rd, and 7th days after the intervention for checkups and tests.
• Keep a diary of their symptoms.

Conditions

Impacted Mandibular Third Molar Extraction

Outcome Measures

Primary Outcomes (4)

• Postoperative complication: pain

  For the assessment of postoperative pain, the Numeric Visual Analogue Scale (VAS) (Carlsson, 1983) and the Verbal Rating Scale (VRS) (Aitken et al., 1969) will be used, which patients will complete. VAS is a horizontally drawn line of 100 mm in length, where the left end represents the absence of pain (0 mm), and the right end (100 mm) represents the worst pain ever experienced. The pain intensity will be determined by measuring the distance from the marked point on the scale to the left side of the scale and expressed in millimeters. The VRS is a numerical assessment of pain intensity based on six levels: 1 - no pain, 2 - very mild pain, 3 - mild pain, 4 - moderate pain, 5 - severe pain, 6 - very severe pain.

  1st, 3rd, and 7th days after the intervention

• Postoperative complication: trismus

  The degree of postoperative trismus will be assessed by measuring the distance between the mesio-incisal angles of the upper and lower central incisors with the mouth fully open, using a caliper. The value will be expressed in millimeters (Marković and Todorović, 2007).

  1st, 3rd, and 7th days after the intervention

• Postoperative complication: swelling

  The assessment of postoperative swelling will be performed by calculating the postoperative edema coefficient (Ec) using the modified formula by Carrillo et al. (1990): Postoperative distance - Preoperative distance x 100 /Preoperative distance. The postoperative Ec will be obtained by measuring in millimeters the preoperative and postoperative distances between the following reference points (R): AC - the most posterior point on the tragus to the lateral point at the corner of the mouth, AD - the most posterior point on the tragus to the prominent soft tissue landmark and BE - the lateral canthus of the eye to the lowest point on the angle of the mandible. Measurement will be done with a flexible ruler just before the intervention (the baseline value used for evaluating subsequent values).

  1st, 3rd, and 7th days after the intervention

• Cytokine levels- wound healing

  To determine the expression of IL-1β, IL-6, IL-8, TNF-α, VEGF, and TGF-β in samples from extraction wounds, real-time polymerase chain reaction (qPCR) will be used. Gene expression will be determined using "housekeeping" genes as standards and appropriate primers, according to the manufacturer's instructions. Each sample will be analyzed in duplicate.

  After surgical intervention, 3rd and 7th days after the intervention

Secondary Outcomes (1)

• Quality of life

  Before and on the 7th day after the intervention

Study Arms (2)

Ozone therapy

EXPERIMENTAL

After the surgical extraction of the impacted mandibular third molar, gaseous ozone will be applied at the extraction site. Ozone will be reapplied 3 days after the intervention, according to the manufacturer's recommendation for wound treatment following tooth extraction.

Drug: Ozone

Sham Comparator

SHAM COMPARATOR

After the surgical extraction of the impacted mandibular third molar, a sham ozone therapy will be applied at the extraction site. The sham ozone therapy will also be reapplied 3 days after the surgical intervention.

Drug: Placebo

Interventions

Ozone DRUG

In Ozone group, ozone will be applied at the site of the extraction wound for 30 seconds after the surgical extraction of the third molar, according to the manufacturer's recommendation for wound treatment following tooth extraction.

Ozone therapy

Placebo DRUG

In the control group, a sham ozone therapy will be applied at the site of the extraction wound for 30 seconds after the surgical extraction of the third molar .

Sham Comparator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over 18 years
• Patients with bilaterally impacted mandibular third molars classified as impaction index II B
• Patients in good general health (based on the ASA classification as ASA I and ASA II).

You may not qualify if:

• Contraindications for ozone application (pregnancy, hyperthyroidism, favism, anemia, myasthenia, bleeding disorders, alcohol intoxication, myocardial infarction, pacemaker, allergy to ozone)
• Patients with signs of local inflammation in the oral cavity
• Female patients during pregnancy and breastfeeding.

Sponsors & Collaborators

• Jelena Krunic: lead

Study Sites (1)

University of East Sarajevo, Faculty of Medicine

Foča, Republika Srpska, 73300, Bosnia and Herzegovina

RECRUITING

Related Publications (5)

• Markovic A, Todorovic Lj. Effectiveness of dexamethasone and low-power laser in minimizing oedema after third molar surgery: a clinical trial. Int J Oral Maxillofac Surg. 2007 Mar;36(3):226-9. doi: 10.1016/j.ijom.2006.10.006. Epub 2006 Dec 8.

  PMID: 17157479 BACKGROUND

• Carrillo JS, Calatayud J, Manso FJ, Barberia E, Martinez JM, Donado M. A randomized double-blind clinical trial on the effectiveness of helium-neon laser in the prevention of pain, swelling and trismus after removal of impacted third molars. Int Dent J. 1990 Feb;40(1):31-6.

  PMID: 2407660 BACKGROUND

• Aitken RC. Measurement of feelings using visual analogue scales. Proc R Soc Med. 1969 Oct;62(10):989-93. doi: 10.1177/003591576906201005. No abstract available.

  PMID: 4899510 BACKGROUND

• Carlsson AM. Assessment of chronic pain. I. Aspects of the reliability and validity of the visual analogue scale. Pain. 1983 May;16(1):87-101. doi: 10.1016/0304-3959(83)90088-X.

  PMID: 6602967 BACKGROUND

• 34. Pell GJ, Gregory BT. Impacted mandibular third molars: Classification and Impacted mandibular third molars: Classification and modified technique for removal. Dent. Digest. 1933;39:330-8.

  BACKGROUND

MeSH Terms

Interventions

Ozone

Intervention Hierarchy (Ancestors)

Oxygen; Gases; Inorganic Chemicals

Central Study Contacts

Jelena Krunic, Professor

CONTACT

+38758210420; jelena.krunic@ues.rs.ba

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: The study is a 'split-mouth' randomized clinical controlled trial.

Study Record Dates

• First Submitted: December 16, 2024
• First Posted: January 31, 2025
• Study Start: December 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: January 31, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF
• Time Frame: IPD supporting information will be available from January 2025 to the May 2025.
• Access Criteria: Access to selected IPD (SAP, ICF) will have all researches from the principal investigator upon request.

Locations

BO (1)