Complications After Lower Third Molar Surgery

NCT05027893 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 157

Last updated 2022-06-15

No results posted yet for this study

Summary

Surgical removal of impacted mandibular wisdom teeth is a frequent intervention, usually accompanied by unpleasant sequelae (pain, swelling and trismus) in the postoperative period, sometimes even with possibly serious complications (dry socket/alveolar osteitis and postoperative infection at the surgical site - SSI). It is therefore advisable to use various medications and procedures to prevent or alleviate the occurrence of these sequelae and complications. Accordingly, there is a debate in the literature on the expedience of perioperative (prophylactic) use of antibiotics. It is interesting that numerous articles recommending perioperative (prophylactic) antibiotic use to patients undergoing the impacted mandibular third molar surgery may be found, as well as those providing arguments for the disagreement with such an approach, considering that its benefits do not outweigh the risks of adverse side effects, especially due to growing resistance of microorganisms towards antibiotics, which is a possible serious threat to global health. Concerning the perioperative (prophylactic) use of antibiotics for this indication, consensus has not yet been reached, and neither of the views has been verified by convincing scientific evidence. Having the aforementioned dilemma in mind, the main endpoint of the study was to determine the validity of perioperative (prophylactic) use of antibiotics as to alleviate customary sequelae and possible complications after surgical removal of impacted mandibular third molars and, at the same time, the effectiveness of newer antibiotics (moxifloxacin and cefixime) when used for this purpose. Moreover, microbiological investigations of susceptibility of the isolated microorganisms to antibiotics used in this research were performed, which could verify the clinically obtained results. With this in mind, two major contributions, based on scientifically verified results, could be expected from the research: (1) confirmation or refuting the validity of perioperative (prophylactic) antibiotic use to control sequelae or complications that could follow the impacted mandibular third molar surgery; and (2) confirmation of the efficacy of fluoroquinolones (moxifloxacin) and cephalosporins (cefixime) in controlling odontogenic infections.

Conditions

  • Postoperative Complications
  • Antibiotic Reaction
  • Antibiotic Side Effect
  • Antibiotic Resistant Infection
  • Antibiotic Resistant Strain
  • Infection, Bacterial
  • Infection, Laboratory

Interventions

DRUG

Moxifloxacin 400 mg Oral Tablet

All used film-coated tablets (400 mg moxifloxacin) were administered for the first five days postoperatively, once a day, after the lower third molar surgery.

DRUG

Cefixime 400 mg Oral Tablet

All used film-coated tablets (400 mg cefixime) were administered for the first five days postoperatively, once a day, after the lower third molar surgery.

OTHER

Placebo

All used film-coated placebo-tablets were administered for the first five days postoperatively, once a day, after the lower third molar surgery.

Sponsors & Collaborators

  • University of Novi Sad

    lead OTHER

Principal Investigators

  • Branislav V Bajkin, MD, DMD, PhD · Dental Clinic of Vojvodina, Faculty of Medicine, University of Novi Sad

  • Branimir D Stošić, DMD, PhD · University of Novi Sad, Faculty of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-07
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • Serbia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05027893 on ClinicalTrials.gov