CLINICAL EVALUATION OF THE USE OF ANTIBIOTICS IN SURGERY FOR DENTAL IMPLANT INSTALLATION: A RANDOMIZED, TRIPLE BLIND AND CONTROLLED CLINICAL TRIAL
Key words: clinical trial, dental implantation, antibiotic prophylaxis, infections
Objective: To clinically evaluate 3 antibiotic prophylaxis regimens in patients undergoing two-stage dental implant placement in a controlled, randomized, triple-blind clinical trial for pain, infection and loss of implants. Materials and methods: A total of 61 patients received 115 dental implants. Data collection was performed by a calibrated and blinded examiner in the following postoperative follow-up periods: T1 (7 days), T2 (14 days), T3 (30 days) and T4 (120 days). Randomization was performed using the random function of Microsoft Excel® (2013), which randomly divided the groups and patients were allocated according to the list generated by the program. The research subjects were divided into 3 groups: group 1 (G1) formed by patients 21 who did not use antibiotic prophylaxis, group 2 (G2) formed by 20 patients who used preoperative antibiotic prophylaxis with 1 g of amoxicillin. oral 1 hour before the procedure and group 3 (G3), with 20 patients who used preoperative antibiotic prophylaxis with amoxicillin 1g orally 1 hour before the procedure and antibiotic maintenance, with 500 mg of amoxicillin for 05 days every 08 hours. The variable pain was analyzed using a visual analogue scale - VAS and the number of analgesics ingested. Infection was considered when in the presence of pus and fistula. In addition, at time T4, the implant was reopened to assess the success of primary osseointegration, considering the absence of mobility and pain when changing the cover screw by the healers. Pain (VAS and number of analgesics) was analyzed with the Kruskall Wallis and the post-test (Post hoc by Dunn). Infection was analyzed using Fisher's exact test and failure descriptively. The level of significance was set at 5%, with a 95% confidence interval. Results: The analysis of postoperative pain showed better results in the groups that used antibiotics (G2 and G3) in the T1 follow-up (7 days), with patients feeling less pain (Kruskall-Wallis test p < 0.05). The evaluation between groups G2 and G3 also showed differences (Post hoc of Dunn-p < 0.05) with superiority for G3. In the other periods there were no significant differences. Infection was present in groups G1 (2 cases) and G3 (2 cases), but there was no statistical difference between the groups (Fisher's exact test - p > 0.05) with evolution to loss (failure) of two implants, one in the G1 group and another in the G3 group. Conclusions: This study showed better results regarding pain in patients who used prophylactic antibiotics, but failed to demonstrate superiority in terms of infection and implant loss when compared to the group without antibiotics. Thus, based on the results of the present study, considering a maximum number of 4 implants per procedure in an ungrafted area, in healthy patients, without additional procedures, the use of antibiotics, although improving pain in the immediate postoperative period, did not show any benefit in relationship to decrease the infection and failure rates of the implants.