Prevention of Dry Socket with Ozone Oil-Based Gel after Inferior Third Molar Extraction: A Double-Blind Split-Mouth Randomized Placebo-Controlled Clinical Trial

Abstract

Tooth extraction is followed by a sequence of elaborate local changes affecting hard and soft tissues. Dry socket (DS) can occur as intense pain around and in the extraction site, with an incidence from 1-4% after generic tooth extraction to 45% for mandibular third molars. Ozone therapy has gained attention in the medical field because of its success in the treatment of various diseases, its biocompatible properties and its fewer side effects or discomfort than drugs. To investigate the preventive effect of the sunflower oil-based ozone gel Ozosan^® (Sanipan srl, Clivio (VA), Italy) on DS, a double-blind split-mouth randomized placebo-controlled clinical trial was conducted according to the CONSORT guidelines. Ozosan^® or the placebo gel were put in the socket, and the gels were washed off 2 min later. In total, 200 patients were included in our study. The patient population comprised 87 Caucasian males and 113 Caucasian females. The mean age of the included patients was 33.1 ± 12.4 years. Ozosan reduced the incidence of DS after inferior third molar extraction from 21.5% of the control to 2% (p < 0.001). Concerning the dry socket epidemiology, the incidence was not significantly correlated with gender, smoking or mesioangular, vertical or distoangular Winter's classification. Post hoc power calculation showed a power of 99.8% for this data, with alpha = 0.001.

Keywords: alveolar osteitis; alveolar periostitides; alveolar periostitis; alveolus; dental; mucositis; oral disease; third molar; wisdom tooth.

Figure 1

Design of experimental set-up according to CONSORT guidelines.

Figure 2

Percentage of Ozosan’s ozone release over time. According to the UNI EN ISO 3960:2017 standards, the total amount of peroxide in the gel was evaluated at 1322.4 meqO2/Kg (100%). The time-temperature-dependent release expressed in % indicates that after 10 min, about 97% of the initial peroxide had been released. Of note, at the same 2 min exposure time employed in our study, less than 20% of the peroxide had been released.