- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05027893
Complications After Lower Third Molar Surgery
Efficacy of the Application of Moxifloxacin and Cefixime in Reduction of Inflammatory Sequelae and Complications After Mandibular Third Molar Surgery
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Clinical research was conducted at the Oral Surgery Department of the Dental Clinic of Vojvodina, Novi Sad, Serbia, adopting the double-blind prospective clinical study design. Microbiological studies were performed at the Center for Microbiology of the Institute of Public Health of Vojvodina, Novi Sad, Serbia, on swab samples obtained from the surgical wounds of patients with postoperative infection or the exudate (pus) obtained from the peri-coronal space of patients with pericoronitis or history of pericoronitis. The susceptibility of isolated microorganisms to moxifloxacin, cefixime and other antibiotics commonly used in oral & maxillofacial surgery (penicillin and its derivatives, erythromycin, azithromycin, clindamycin and tetracycline) was tested microbiologically. Patients ≥18 years, indicated for surgical removal of the impacted mandibular third molars, with good systemic health - patients classified as American Society of Anesthesiologists (ASA) classification of Physical Health is a grading system for preoperative health of the surgical patients - ASA I and ASA II were included in the study. Evaluation of the effects of the applied medication was performed on the basis of postoperative sequelae or complications. Complications, including dry socket/alveolar osteitis (AO) and postoperative infection at the surgical site (SSI), and inflammatory sequelae - pain, swelling and trismus (limited mouth opening), were evaluated postoperatively.
In the case of pericoronitis or a history of pericoronitis, with the presence of exudate or pus, as well as in the case of postoperative infection, a swab was taken from the operative wound or pericoronary space, and the punctate of exudate or pus was sent for microbiological analysis. The main goal of this analysis was to establish the susceptibility of microorganisms not only to antibiotics used in this study, but also to antibiotics, which are the "gold standard" in the treatment of odontogenic infections, as well as other commonly used antibiotics in the treatment. Analyses were performed by standard bacteriological techniques (seeding the material on appropriate nutrient media and incubating them at 35-37 °C for 18-24 h) to isolate the bacteria. Identification of bacterial species was performed by classical bacteriological methods (morphological, cultural and physiological-biochemical), as well as by the automated system Matrix Assisted Laser Desorption Ionization - Time of Flight (MALDI-TOF), Germany. After identification, susceptibility testing of isolated bacterial species to antimicrobial drugs was performed by standard disk-diffusion method according to Kirby-Bauer, Mueller-Hinton agar and blood Mueller-Hinton agar (HiMedia, India), depending on which bacterial species was in question in line with European Committee on Antimicrobial Susceptibility Testing (EUCAST) or Clinical & Laboratory Standards Institute (CLSI) Guidelines. Discs from Bio-Rad, France, were used to perform the microbiological analyses.
All surgical interventions were performed under local anesthesia, using 2% lidocaine with adrenaline 1: 80,000 in a total 4 ml volume (2 ml solution for injection contained 40 mg lidocaine hydrochloride in the form of lidocaine hydrochloride monohydrate and 0.025 mg adrenaline in the form of adrenaline tartrate: Lidocaine 2% - adrenaline, 40 mg +0.025. In all patients, the surgery involved a triangular mucoperiosteal flap design, sutured using synthetic poly-filament non-resorptive suture material (3-0). Patients were advised to take an analgesic containing 200 mg ibuprofen and 325 mg acetaminophen.
In accordance with known ethical principles and in accordance with the principles of Good Clinical Practice (GCP), care for the well-being of the patients was maximally respected, in accordance with the latest revision of the Declaration of Helsinki and accepted principles that apply to clinical trials on humans. The holder of the protection of the patients in this clinical trial was the principal researcher, who cooperated with the Ethics Committee of the Dental Clinic of Vojvodina, University of Novi Sad. The patients written Informed Consent implied that the patient had received full information about the research, and was stressed that they had the right to decide independently to participate, without coercion and external influences, or any harmful consequences if they refused to participate.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Vojvodina
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Novi Sad, Vojvodina, Serbia, 21000
- Dental Clinic of Vojvodina, Faculty of Medicine, University of Novi Sad
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: Active Comparator: The first tested group
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.
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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.
Other Names:
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Active Comparator: Active Comparator: The second tested group
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.
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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 Names:
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Placebo Comparator: Placebo Comparator: The control group
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.
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All used film-coated placebo-tablets were administered for the first five days postoperatively, once a day, after the lower third molar surgery.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of postoperative infection at the surgical site (SSI)
Time Frame: Up to 12 weeks (3 months) after surgery.
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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. ).
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Up to 12 weeks (3 months) after surgery.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dry socket (alveolar osteitis)
Time Frame: Through 7 days.
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The dry socket (alveolar osteitis) was diagnosed based on reported severe pain in the wound area, accompanied by specific local clinical appearance of the operative wound and absence of pus.
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Through 7 days.
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Postoperative pain assessed by visual analogue scale (VAS)
Time Frame: 1st, 2nd day and 7th day after surgery.
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The postoperative pain was assessed using a visual analogue scale (VAS).
VAS represents a horizontally drawn length of 100 mm, the beginning of which indicates a pain-free state on the left side, and the end on the right side the state of the strongest pain imaginable.
All patients, by placing a dash on the scale, indicated the intensity of pain that, on the appropriate day in the postoperative period, they felt in its strongest intensity.
The intensity of pain was determined by measuring the distance of the marked place on the scale from the beginning of the scale on the left side and expressed in millimeters.
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1st, 2nd day and 7th day after surgery.
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Postoperative swelling (oedema)
Time Frame: 1st, 2nd day and 7th day after surgery.
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The postoperative swelling (oedema) coefficient was obtained by measuring the preoperative and postoperative distance between specific reference points in millimetres.
The reference points were: the outer corner of the eye and the angle of the lower jaw; lip corner and tragus; and chin tip and tragus.
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1st, 2nd day and 7th day after surgery.
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Postoperative trismus (maximum inter-incisal opening of mouth)
Time Frame: 1st, 2nd day and 7th day after surgery.
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The degree of postoperative trismus was assessed by measuring the distance between mesio-incisal angles of the upper and lower central incisors at the maximum mouth opening ability.
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1st, 2nd day and 7th day after surgery.
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Postoperative pain assessed by verbal rating scale (VRS)
Time Frame: 1st to 7th day after surgery.
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The postoperative pain was assessed using a verbal rating scale (VRS).
VRS involves a numerical assessment of pain intensity based on six degrees (1-6) - no pain, barely sensitive pain, mild pain, moderate pain, severe pain and very strong, almost unbearable pain.
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1st to 7th day after surgery.
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Postoperative pain assessed by number of analgesics
Time Frame: 1st to 7th day after surgery.
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In each patient, the moment of postoperative pain, its intensity at the indicated observation times was registered, and the need for additional analgesics was registered (patients recorded the number of analgesics consumed daily from the completed surgical intervention to suture removal in the postoperative pain monitoring protocol).
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1st to 7th day after surgery.
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of antibiotic susceptibility and resistance of isolated microorganisms in vitro (microbiological assessment).
Time Frame: Up to 12 weeks (3 months) after surgery.
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The sensitivity of isolated microorganisms to moxifloxacin, cefixime and other antibiotics commonly prescribed in oral and maxillofacial surgery was tested microbiologically.
Regarding the susceptibility to antimicrobial drugs, bacteria were classified according to the growth inhibition zone, into three categories: susceptible (S), intermediate (I) and resistant (R).
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Up to 12 weeks (3 months) after surgery.
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Incidence of adverse drug events (ADEs) in the clinical trial
Time Frame: Up to 24 days after surgery.
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During the study, any adverse event to drugs used in the clinical study will be recorded in accordance with the GCP.
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Up to 24 days after surgery.
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Branislav V Bajkin, MD, DMD, PhD, Dental Clinic of Vojvodina, Faculty of Medicine, University of Novi Sad
- Study Director: Branimir D Stošić, DMD, PhD, University of Novi Sad, Faculty of Medicine
Publications and helpful links
General Publications
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Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Disease Attributes
- Bacterial Infections and Mycoses
- Occupational Diseases
- Infections
- Communicable Diseases
- Postoperative Complications
- Bacterial Infections
- Laboratory Infection
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antineoplastic Agents
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Anti-Bacterial Agents
- Moxifloxacin
- Cefixime
Other Study ID Numbers
- 01-33/8-2019
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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