Efficacy of Ozone Therapy in Reducing Complications Following Impacted Mandibular Third-molar Surgery
NCT ID: NCT06802354
Last Updated: 2025-01-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
20 participants
INTERVENTIONAL
2024-12-01
2025-05-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
QUADRUPLE
Study Groups
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Ozone therapy
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.
Ozone
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.
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.
Placebo
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 .
Interventions
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Ozone
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.
Placebo
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 .
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Jelena Krunic
OTHER
Responsible Party
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Jelena Krunic
Associate Professor
Locations
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University of East Sarajevo, Faculty of Medicine
Foča, Republika Srpska, Bosnia and Herzegovina
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
Other Identifiers
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19.032/961-110/23
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
01-2-9
Identifier Type: -
Identifier Source: org_study_id
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