Effect of ozone therapy on post-operative pain following mandibular third molar surgical extraction: a split-mouth randomized clinical trial

Objectives: To evaluate the efficacy of ozone therapy on pain reduction, trisma and number of analgesic tablets taken following surgical removal of impacted mandibular third molar. Methods: A split-mouth randomized clinical trial was conducted in 54 patients in need of bilateral impacted mandibular third molars (Pell-Gregory class II-B) extraction. Test sites were treated with adjunctive ozone therapy to the surgical extraction, while controls underwent surgical intervention only (time between surgeries: 3 weeks). Study primary outcome measure was the difference in perceived pain recorded using a Numerical Rating Scale (NRS) at 7 days after surgery. In addition, functional limitation in mouth opening (mm), number of analgesic tablets taken within one week after surgery as well as the patient’s perceived quality of life (Oral Health Impact Profile (OHIP-14) were evaluated. Results: Fifty patients (20 males and 30 females; median age: 21 years; all non-smokers) completed the study. Mean reported perceived pain decrease from 5.06 to 0.58 (test group) and from 5.62 to 1.08 (control group) between day 1 and 7. No statistically significant differences were detected between the two groups at any time points (p > 0.05). At day 7, mean mouth opening value was 40.8 vs. 36.6 mm in test and control group respectively (mean difference: 4.24 mm; p < 0.001; 95% CI: 6.55–1.93). The same trend was detected for the of number of analgesic tablets taken (median: 4 vs. 7; p = 0.01). Finally, OHIP-14 values did not differ between groups (p > 0.05). Conclusion: Ozone therapy had a beneficial clinical effect in terms of mouth opening and in the number of analgesic tablets intake at 7 days after surgical removal of impacted mandibular third molar, despite the lack of adjunctive benefit on patients perceived pain reduction. Clinical relevance: The clinical use of ozone therapy as adjunct to surgical removal of impacted mandibular third molar might be considered in light of the promising positive reported results in terms of mouth opening reduction and analgesic intake. Clinical trial registration number: NCT05949476