Material and Methods
swelling, incisors, Trismus, pain, trismus
SYSTEMIC DISEASE, IMPACTED MOLARS, POSTOPERATIVE COMPLICATIONS, TRISMUS, FACIAL SWELLING, DRY SOCKET, TRISMUS, COMPLICATIONS
- Study design and sampleThis randomized, prospective, three-arm clinical study consisted of patients who presented to the Department of Oral and Maxillofacial Surgery for surgical removal of a bilaterally impacted mandibular third molar from October 2021 to April 2022. Patients participated voluntarily and signed an informed consent form as well as understood and complied with the research scheme. The study protocol was reviewed and approved by the Ethics Committee of the Stomatological Hospital, Southern Medical University, Guangzhou. All procedures performed in studies involving human participants were in accordance with the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards. The objective of the procedure was explained during the first appointment. All the patients were informed of the potential complications and benefits. All patients were treated by the same surgeon (G.J.Y), a specialist with more than 10 years of experience in oral and maxillofacial surgery. The reporting of the methodology used in this study conforms with the CONSORT Statement (- Inclusion and exclusion criteriaThe Winter and Pell and Gregory classifications were used to evaluate the inclusion and exclusion criteria. The molars were horizontally/mesio-angularly impacted, and all teeth were partially or completely covered by mucosa. The region, size, and resistance distribution of the impacted molars were similar as seen on panoramic radiographs. Patients with any systemic disease, poor oral hygiene, age < 18, or who failed to attend follow-ups were excluded from this study. Smokers were not excluded from this study, but all the patients were informed not smoke at least two weeks after surgery. Patients with differences in operation time that exceeded 5 minutes were also excluded from the study.- Sample size calculationA priori power analysis was carried out during the planning stage of this experiment to determine the ideal sample size. The ideal sample size was calculated using G* power software version 3.1.9.7 to ensure adequate computing power for the study. To detect a difference between the groups with a two-sided 5% significance level and a power of 80%, a sample size of 84 patients was necessary, and this was increased to 90 patients to compensate for possible losses.- RandomizationA block permuted randomisation was used with variable block size (
CONSORT flow diagram of the patients in the trial.- Surgical procedureThe surgery was carried out with the patients under local anesthesia. The anesthetic used was Articaine in a 4% solution with additional epinephrine in a concentration of 1:100000 (Primacaine, France). All patients were cut with an electric knife (XO Odontosurge4, Denmark). The traditional triangular flap incision was implemented as described by Szmyd 
Incision line. (a) Incision line used in this study. (b) Traditional incision line.
Suture method in this study. (a) Airtight suture method. (b) Buccal drainage method. (c) No-suture method.- Postoperative MedicaltionsAll patients in the study routinely received amoxicillin (oral 500 mg every 8 hours) for 3 days after surgery. Chlorhexidine solution (0.12%) was administered 3 times a day for 7 days. Ibuprofen was taken only if required to control post-operative pain and edema.- Postoperative follow-up and measurementAll patient treatment times were recorded (from the first incision to the last suture);the operator and the dental assistant who performed the surgical interventions were not blinded due to the nature of the interventions. One author, who performed all the measurements and was responsible for the calculations and calibrations, was not involved in the selection and intervention of the participants. Postoperative measurements, that included details of pain, trismus, swelling, quality of life, dry socket, and other postoperative complications, were repeated twice and the mean values were recorded. The data collection methods are as follows:All patients were given a 10-cm standard visual analog scale (VAS) form—the scoring ranged from “0” meaning no pain on the left to “10” meaning the worst possible pain on the right. Patients were asked to indicate the point on the scale that best corresponds to their pain on postoperative days 1, 3, and 7. They were also asked to record analgesic requirements for the 7 days after surgery. Trismus was performed by measuring the distance between the mesial-incisal corners of the upper and lower right central incisors at a maximum opening of the jaws for pre-operative and post-operative (after 1, 3, and 7 days) conditions. Facial swelling was determined based on soft tape measurements between the tragus and the soft tissue pogonion, the tragus and the lateral corner of the mouth, the lateral corner of the eye, and the angle of the mandible. Percentages were calculated from the differences between the pre-operative and the 1, 3, and 7 days post-operative measurements. The results were then divided by the value obtained in the pre-operative period and multiplied by 100, as described in Amin Another important measurement was the modified questionnaire on postoperative patient quality of life (QOL) (- Statistical analysisStatistical analysis was performed using the SPSS for Windows version 23.0 (SPSS Inc., Chicago, IL). The Shapiro-Wilk test was performed, and the results were expressed as mean ± standard deviation in order to verify the normal distribution of the data. The statistical differences were performed using the Pearson's chi-squared test, one-way ANOVA, and the Kruskal-Wallis test with Bonferroni post-hoc correction, for data normally distributed and non-normally distributed,. The level of significance was set at 