Highly Ozonated Sunflower Oil Dose May Cause Oxidative Stress and Impact the Quality of Life After Palatal Graft Removal: Secondary Endpoints of a Randomized Controlled Clinical Trial

ABSTRACT

The aim of this study was to evaluate the effect of highly ozonated sunflower oil on postoperative pain and quality of life in patients undergoing removal of a free gingival graft (FGG) in the donor area of the palate. After graft removal, the palatal wound was treated with highly ozonated sunflower oil with a peroxide index between 510 and 625 meq/kg in the test group (n = 14) and with non-ozonated sunflower oil in the control group (n = 14). These are the secondary endpoints of a randomized clinical trial. Questionnaires assessing oral health impact on quality of life (OHIP-14) and postoperative pain (VAS scale) were applied to all participants at day 7. The results did not reveal a statistically significant difference in the postoperative pain between groups in all periods (P>0.05). There was a significant positive correlation in both groups for pain and amount of analgesic consumption (P<0.0001). It was found that participants in the test group showed a higher overall score for OHIP-14 than the control group (P < 0.05), with impact on unsatisfactory diet, meal interruptions and irritability (P < 0.05). MDA levels measured 7 days post-treatment were higher in the test group compared to those of the control group (P < 0.05). It can be concluded that high dose and overapplication of the ozonated sunflower oil had a negative impact on the quality of life of individuals after palatal graft removal, which might have been aggravated by oxidative stress.

Trial Registration number

NCT05620550/Date of registration: November 16, 2022

KEYWORDS:

• Health-related quality of life
• ozone
• pain
• periodontics
• wound healing

Disclosure statement

No potential conflict of interest was reported by the author(s).

Sources of support in the form of grants

We thank the company Philozon (Philozon Ind. e Trade Ozone Generators, Balneário Camburiú, SC, Brazil) for donating ozonated sunflower oils to the test group and non-ozonated oil to the control group.

Author’s contribution

EPZ, AAS, EMC, and RLR have been involved in conception, design, data analysis, and drafting of the paper. PJ, BBL, AAS, and EPZ have been involved in data collection in the clinical experimental phases. JCL and IFS were responsible for the laboratory analysis. All authors have revised the manuscript critically and have given final approval of the version to be published.

Correction Statement

This article has been corrected with minor changes. These changes do not impact the academic content of the article.

Notes

¹ *www.random.org (Random.org, Dublin, Ireland).