Complications After Lower Third Molar Surgery

NCT05027893 | Unknown DMC

• 1 other identifier: 01-33/8-2019
• Study Type: interventional
• Target: 157
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Molar, Third; Moxifloxacin; Cefixime; Placebo; Postoperative Complications; Antibiotic Prophylaxis; Drug Resistance; Microbial Sensitivity Tests

Outcome Measures

Primary Outcomes (1)

• Rate of postoperative infection at the surgical site (SSI)

  Signs of postoperative infection were registered clinically, based on the presence of local signs of inflammation and general signs of intoxication (elevated body temperature, accelerated erythrocyte sedimentation, leucocytosis, the level of C-reactive protein, etc. ).

  Up to 12 weeks (3 months) after surgery.

Secondary Outcomes (6)

• Dry socket (alveolar osteitis)

  Through 7 days.

• Postoperative pain assessed by visual analogue scale (VAS)

  1st, 2nd day and 7th day after surgery.

• Postoperative swelling (oedema)

  1st, 2nd day and 7th day after surgery.

• Postoperative trismus (maximum inter-incisal opening of mouth)

  1st, 2nd day and 7th day after surgery.

• Postoperative pain assessed by verbal rating scale (VRS)

  1st to 7th day after surgery.

Other Outcomes (2)

• Rate of antibiotic susceptibility and resistance of isolated microorganisms in vitro (microbiological assessment).

  Up to 12 weeks (3 months) after surgery.

• Incidence of adverse drug events (ADEs) in the clinical trial

  Up to 24 days after surgery.

Study Arms (3)

Active Comparator: The first tested group

ACTIVE COMPARATOR

Patients orally received film-coated tablets with either 400 mg of moxifloxacin. Film-coated tablets were administered for the first five days postoperatively, once a day, in a double-blind manner. All patients were evaluated at the postoperative follow-ups on the first, second and seventh postoperative day.

Drug: Moxifloxacin 400 mg Oral Tablet

Active Comparator: The second tested group

ACTIVE COMPARATOR

Patients orally received film-coated tablets with either 400 mg of cefixime. Film-coated tablets were administered for the first five days postoperatively, once a day, in a double-blind manner. All patients were evaluated at the postoperative follow-ups on the first, second and seventh postoperative day.

Drug: Cefixime 400 mg Oral Tablet

Placebo Comparator: The control group

PLACEBO COMPARATOR

One third of patients received placebo-tablets containing indifferent substances with no antimicrobial action (99% microcrystalline cellulose, 0.5% silicon dioxide and 0.5% magnesium stearate, which were of the same colour and overall appearance as the used antibiotics. Film-coated tablets were administered for the first five days postoperatively, once a day, in a double-blind manner. All patients were evaluated at the postoperative follow-ups on the first, second and seventh postoperative day.

Other: Placebo

Interventions

Moxifloxacin 400 mg Oral Tablet DRUG

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.

Also known as: perioperative/prophylaxis

Active Comparator: The first tested group

Cefixime 400 mg Oral Tablet DRUG

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.

Also known as: perioperative/prophylaxis

Active Comparator: The second tested group

Placebo OTHER

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

Placebo Comparator: The control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients ≥18 years, indicated for surgical removal of the impacted mandibular third molars, with good systemic health (patients classified as ASA I and ASA II) were included in the study.

You may not qualify if:

• hypersensitivity to study drugs; history of systemic antibacterial therapy within 6 months prior to randomization; pregnancy or breastfeeding; fluoroquinolone-related tendon disorder; clinically relevant cardiac conditions or QT interval prolonging drugs; severe hepatic insufficiency (Child-Pugh C). Also, criteria for not including the patients in the study were cases where, in addition to removing the impacted mandibular third molar, some other oral surgical procedure was performed, as well as patients with currently present pericoronitis.

Sponsors & Collaborators

• University of Novi Sad: lead

Study Sites (1)

Dental Clinic of Vojvodina, Faculty of Medicine, University of Novi Sad

Novi Sad, Vojvodina, 21000, Serbia

Location

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Related Links

• A comparative analysis of the efficacy of moxifloxacin and cefixime in reduction postoperative inflammatory sequelae after mandibular third molar surgery

MeSH Terms

Conditions

Postoperative Complications; Bacterial Infections; Laboratory Infection

Interventions

Moxifloxacin; Tablets; Cefixime

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bacterial Infections and Mycoses; Infections; Occupational Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dosage Forms; Pharmaceutical Preparations; Cefotaxime; Cephacetrile; Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds

Study Officials

• Branislav V Bajkin, MD, DMD, PhD

  Dental Clinic of Vojvodina, Faculty of Medicine, University of Novi Sad

  STUDY CHAIR

• Branimir D Stošić, DMD, PhD

  University of Novi Sad, Faculty of Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patients were randomly and equally assigned to treatment groups. The study was planned as a double-blind. Thus, neither the patients nor the researchers knew whether the patients were prescribed antibiotics or placebo tablets, because the tablets were marked with a label that was in the formed codebook. All the film-coated tablets used were of the same appearance (both the antibiotics and the placebo). There was 157 participants, patients and the same oral surgeon.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, DMD, PhD, University Full Professor, Vice Dean for PhD studies

Model Details: A RANDOMIZED CONTROLLED TRIAL

Study Record Dates

• First Submitted: July 27, 2021
• First Posted: August 30, 2021
• Study Start: June 7, 2019
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: June 15, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)