Clinical trial NCT06802354: Efficacy of Ozone Therapy in Reducing Complications Following Impacted Mandibular Third-molar Surgery
Official title: Application of Gaseous Ozone in the Surgical Extraction of Impacted Mandibular Third Molars: Impact on the Incidence of Postoperative Complications and Healing Processes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Impacted Mandibular Third Molar Extraction
Lead sponsor: University of East Sarajevo
Sponsor class: OTHER
First posted: 2025-01-31
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: The study is a 'split-mouth' randomized clinical controlled trial.
Primary purpose: TREATMENT

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.

Detailed description: The aims of this study were: (i) to determine the effects of gaseous ozone on pain, swelling, and trismus and healing process measured by cytokine levels, and (ii) to measure patient quality of life after impacted mandibular third molar surgery.

All participants included in the study will be informed about the aims and expected outcomes of the research, the sample collection procedure, and will sign an informed consent form. All participants will be treated according to the principles of good clinical practice and in accordance with the Helsinki Declaration. The Ethics Committee of the Faculty of Medicine provide study approval.

The surgical procedure for each patient will be performed using a standardized surgical technique in two clinical visits (one side per visit).

The surgical area will be disinfected. To ensure pain relief during the procedure, local anesthesia will be applied using blocks of the inferior alveolar and buccal nerves. After elevating the flap, osteotomy will be performed with a carbide drill using an air drill and continuous irrigation with saline solution. Depending on the morphology of the tooth, the third molar will either be extracted or the crown will be separated from the roots (separation). The wound will be primarily closed with individual sutures, and the sutures will be removed on the seventh postoperative day. After the surgical extraction of the third molar belonging the ozone therapy group, gaseous ozone will be applied to the extraction wound. Ozone will be reapplied 3 days after the intervention. After the surgical extraction of the third molar assigned to the sham ozone therapy, ozone will be applied by placing an inactive AV probe at the extraction site. The sham ozone therapy will also be applied 3 days after the surgical intervention. Postoperative instructions will be given to participants regarding oral hygiene maintenance, the use of cold compresses, and dietary recommendations. All participants will be invited for follow-up examinations on the 1st, 3rd and 7th day after the intervention.

Statistical data analysis will be conducted using SPSS version 20.0 (IBM SPSS Statistics for Windows, Version 20.0. Armonk, NY: IBM Corp, USA). Normality testing will be performed, and depending on the results, parametric and/or non-parametric tests will be applied. To compare differences between groups, chi-square tests, independent t-tests, and/or Mann-Whitney tests will be used. To determine differences within groups, paired t-tests and/or Wilcoxon tests will be applied. The correlation between variables will be determined using Pearson or Spearman correlation. A p-value of \<0.05 will be considered statistically significant in all analyses.

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* Contraindications for ozone application (pregnancy, hyperthyroidism, favism, anemia, myasthenia, bleeding disorders, alcohol intoxication, myocardial infarction, pacemaker, allergy to ozone)
* Patients who have used corticosteroid and antibiotic therapy in the last three months prior to inclusion in the study
* Patients with signs of local inflammation in the oral cavity
* Female patients during pregnancy and breastfeeding.

Primary outcomes:
measure: Postoperative complication: pain
timeFrame: 1st, 3rd, and 7th days after the intervention
measure: Postoperative complication: trismus
timeFrame: 1st, 3rd, and 7th days after the intervention
measure: Postoperative complication: swelling
timeFrame: 1st, 3rd, and 7th days after the intervention
measure: Cytokine levels- wound healing
timeFrame: After surgical intervention, 3rd and 7th days after the intervention
Secondary outcomes:
measure: Quality of life
timeFrame: Before and on the 7th day after the intervention
Other outcomes:
Locations:
city: Foca
country: Bosnia and Herzegovina
facility: University of East Sarajevo, Faculty of Medicine
state: Republic Of Srpska
Study officials:
References:
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citation: 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.
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citation: 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.