Postoperative ComplicationsNCT05027893
Complications After Lower Third Molar Surgery
A study testing Moxifloxacin 400 mg Oral Tablet and Cefixime 400 mg Oral Tablet in people with Postoperative Complications and Antibiotic Reaction, run by University of Novi Sad at 1 site in Serbia.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Complications, Antibiotic Reaction, Antibiotic Side Effect
- What is being tested?
- Moxifloxacin 400 mg Oral Tablet and Cefixime 400 mg Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 157 participants
- Where
- 1 siteSerbia
- Study dates
- 7 Jun 2019to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Serbia1 site
Dental Clinic of Vojvodina, Faculty of Medicine, University of Novi Sad
Novi Sad, Vojvodina, 21000
About this study
Official title: Efficacy of the Application of Moxifloxacin and Cefixime in Reduction of Inflammatory Sequelae and Complications After Mandibular Third Molar Surgery
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.
Read the 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.
- Conditions
- Postoperative Complications, Antibiotic Reaction, Antibiotic Side Effect, Antibiotic Resistant Infection, Antibiotic Resistant Strain, Infection, Bacterial
- Being tested
- Moxifloxacin 400 mg Oral Tablet, Cefixime 400 mg Oral Tablet, Placebo
- Keywords
- Molar, Third; Moxifloxacin; Cefixime; Placebo, Postoperative Complications; Antibiotic Prophylaxis, Drug Resistance; Microbial Sensitivity Tests
- Medical subject headings
- Postoperative Complications, Bacterial Infections, Laboratory Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moxifloxacin 400 mg Oral TabletDrug
Also called perioperative/prophylaxis
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.
Cefixime 400 mg Oral TabletDrug
Also called perioperative/prophylaxis
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.
PlaceboOther
All used film-coated placebo-tablets were administered for the first five days postoperatively, once a day, after the lower third molar surgery.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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. ).
Measured: Up to 12 weeks (3 months) after surgery.
Secondary outcomes (6)
Dry socket (alveolar osteitis)
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.
Measured: Through 7 days.
Postoperative pain assessed by visual analogue scale (VAS)
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.
Measured: 1st, 2nd day and 7th day after surgery.
Postoperative swelling (oedema)
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.
Measured: 1st, 2nd day and 7th day after surgery.
Postoperative trismus (maximum inter-incisal opening of mouth)
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.
Measured: 1st, 2nd day and 7th day after surgery.
Postoperative pain assessed by verbal rating scale (VRS)
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.
Measured: 1st to 7th day after surgery.
Postoperative pain assessed by number of analgesics
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).
Measured: 1st to 7th day after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2021
- Study start7 Jun 2019
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (73)Papers the sponsor has linked to this study.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A RANDOMIZED CONTROLLED TRIAL
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Novi Sad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Branislav Bajkin, University of Novi Sad
- Investigators
- Branislav V Bajkin, MD, DMD, PhD, Study chair, Dental Clinic of Vojvodina, Faculty of Medicine, University of Novi SadBranimir D Stošić, DMD, PhD, Study director, University of Novi Sad, Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05027893
- Sponsor's protocol ID
- 01-33/8-2019
- Status last verified
- Jun 2022
- First submitted
- 27 Jul 2021
- Last updated
- 15 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Carter K, Worthington S. Predictors of Third Molar Impaction: A Systematic Review and Meta-analysis. J Dent Res. 2016 Mar;95(3):267-76. doi: 10.1177/0022034515615857. Epub 2015 Nov 11.
PubMed 26561441Bouloux GF, Steed MB, Perciaccante VJ. Complications of third molar surgery. Oral Maxillofac Surg Clin North Am. 2007 Feb;19(1):117-28, vii. doi: 10.1016/j.coms.2006.11.013.
PubMed 18088870Chuang SK, Perrott DH, Susarla SM, Dodson TB. Age as a risk factor for third molar surgery complications. J Oral Maxillofac Surg. 2007 Sep;65(9):1685-92. doi: 10.1016/j.joms.2007.04.019.
PubMed 17719384Azenha MR, Kato RB, Bueno RB, Neto PJ, Ribeiro MC. Accidents and complications associated to third molar surgeries performed by dentistry students. Oral Maxillofac Surg. 2014 Dec;18(4):459-64. doi: 10.1007/s10006-013-0439-9. Epub 2013 Dec 27.
PubMed 24370576Markovic AB, Todorovic L. Postoperative analgesia after lower third molar surgery: contribution of the use of long-acting local anesthetics, low-power laser, and diclofenac. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Nov;102(5):e4-8. doi: 10.1016/j.tripleo.2006.02.024. Epub 2006 Aug 10.
PubMed 17052624Schalch TO, Palmieri M, Longo PL, Braz-Silva PH, Tortamano IP, Michel-Crosato E, Mayer MPA, Jorge WA, Bussadori SK, Pavani C, Negreiros RM, Horliana ACRT. Evaluation of photodynamic therapy in pericoronitis: Protocol of randomized, controlled, double-blind study. Medicine (Baltimore). 2019 Apr;98(17):e15312. doi: 10.1097/MD.0000000000015312.
PubMed 31027098Kim JC, Choi SS, Wang SJ, Kim SG. Minor complications after mandibular third molar surgery: type, incidence, and possible prevention. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Aug;102(2):e4-11. doi: 10.1016/j.tripleo.2005.10.050. Epub 2006 Jun 27.
PubMed 16876044Monaco G, Staffolani C, Gatto MR, Checchi L. Antibiotic therapy in impacted third molar surgery. Eur J Oral Sci. 1999 Dec;107(6):437-41. doi: 10.1046/j.0909-8836.1999.eos107604.x.
PubMed 10625102Monaco G, Tavernese L, Agostini R, Marchetti C. Evaluation of antibiotic prophylaxis in reducing postoperative infection after mandibular third molar extraction in young patients. J Oral Maxillofac Surg. 2009 Jul;67(7):1467-72. doi: 10.1016/j.joms.2008.12.066.
PubMed 19531419Susarla SM, Dodson TB. Risk factors for third molar extraction difficulty. J Oral Maxillofac Surg. 2004 Nov;62(11):1363-71. doi: 10.1016/j.joms.2004.05.214.
PubMed 15510357Yuasa H, Kawai T, Sugiura M. Classification of surgical difficulty in extracting impacted third molars. Br J Oral Maxillofac Surg. 2002 Feb;40(1):26-31. doi: 10.1054/bjom.2001.0684.
PubMed 11883966Blum IR. Contemporary views on dry socket (alveolar osteitis): a clinical appraisal of standardization, aetiopathogenesis and management: a critical review. Int J Oral Maxillofac Surg. 2002 Jun;31(3):309-17. doi: 10.1054/ijom.2002.0263.
PubMed 12190139Bowe DC, Rogers S, Stassen LF. The management of dry socket/alveolar osteitis. J Ir Dent Assoc. 2011 Dec-2012 Jan;57(6):305-10.
PubMed 22338284Taberner-Vallverdu M, Nazir M, Sanchez-Garces MA, Gay-Escoda C. Efficacy of different methods used for dry socket management: A systematic review. Med Oral Patol Oral Cir Bucal. 2015 Sep 1;20(5):e633-9. doi: 10.4317/medoral.20589.
PubMed 26116842Taberner-Vallverdu M, Sanchez-Garces MA, Gay-Escoda C. Efficacy of different methods used for dry socket prevention and risk factor analysis: A systematic review. Med Oral Patol Oral Cir Bucal. 2017 Nov 1;22(6):e750-e758. doi: 10.4317/medoral.21705.
PubMed 29053647
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the Application of Moxifloxacin and Cefixime in Reduction of Inflammatory Sequelae and Complications After Mandibular Third Molar Surgery
- ClinicalTrials.gov ID
- NCT05027893
- Acronym / sponsor ID
- 01-33/8-2019
- Conditions
- Postoperative Complications, Antibiotic Reaction, Antibiotic Side Effect, Antibiotic Resistant Infection, Antibiotic Resistant Strain, Infection, Bacterial
- Keywords
- Molar, Third; Moxifloxacin; Cefixime; Placebo, Postoperative Complications; Antibiotic Prophylaxis, Drug Resistance; Microbial Sensitivity Tests
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 157 participants (actual)
- Lead sponsor
- University of Novi SadUniversity, hospital or other
- Study start
- 7 Jun 2019 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 30 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- A RANDOMIZED CONTROLLED TRIAL
| Arm | Type | Receives |
|---|---|---|
| Active Comparator: The first tested group | Active comparator | Drug: Moxifloxacin 400 mg Oral TabletPatients 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. |
| Active Comparator: The second tested group | Active comparator | Drug: Cefixime 400 mg Oral TabletPatients 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. |
| Placebo Comparator: The control group | Placebo comparator | Other: PlaceboOne 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moxifloxacin 400 mg Oral TabletAlso: perioperative/prophylaxisAll 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 | Active Comparator: The first tested group |
| Cefixime 400 mg Oral TabletAlso: perioperative/prophylaxisAll used film-coated tablets (400 mg cefixime) were administered for the first five days postoperatively, once a day, after the lower third molar surgery. | Drug | Active Comparator: The second tested group |
| PlaceboAll used film-coated placebo-tablets were administered for the first five days postoperatively, once a day, after the lower third molar surgery. | Other | Placebo Comparator: The control group |
Primary outcome
Rate of postoperative infection at the surgical site (SSI)
Time frame: Up to 12 weeks (3 months) after surgery.
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. ).
6 secondary outcomes
Dry socket (alveolar osteitis)
Time frame: Through 7 days.
Postoperative pain assessed by visual analogue scale (VAS)
Time frame: 1st, 2nd day and 7th day after surgery.
Postoperative swelling (oedema)
Time frame: 1st, 2nd day and 7th day after surgery.
Postoperative trismus (maximum inter-incisal opening of mouth)
Time frame: 1st, 2nd day and 7th day after surgery.
Postoperative pain assessed by verbal rating scale (VRS)
Time frame: 1st to 7th day after surgery.
Postoperative pain assessed by number of analgesics
Time frame: 1st to 7th day after surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2022.
- Results publication: PubMed 26561441Carter K, Worthington S. Predictors of Third Molar Impaction: A Systematic Review and Meta-analysis. J Dent Res. 2016 Mar;95(3):267-76. doi: 10.1177/0022034515615857. Epub 2015 Nov 11.
- Results publication: PubMed 18088870Bouloux GF, Steed MB, Perciaccante VJ. Complications of third molar surgery. Oral Maxillofac Surg Clin North Am. 2007 Feb;19(1):117-28, vii. doi: 10.1016/j.coms.2006.11.013.
- Results publication: PubMed 17719384Chuang SK, Perrott DH, Susarla SM, Dodson TB. Age as a risk factor for third molar surgery complications. J Oral Maxillofac Surg. 2007 Sep;65(9):1685-92. doi: 10.1016/j.joms.2007.04.019.
- Results publication: PubMed 24370576Azenha MR, Kato RB, Bueno RB, Neto PJ, Ribeiro MC. Accidents and complications associated to third molar surgeries performed by dentistry students. Oral Maxillofac Surg. 2014 Dec;18(4):459-64. doi: 10.1007/s10006-013-0439-9. Epub 2013 Dec 27.
- Results publication: PubMed 17052624Markovic AB, Todorovic L. Postoperative analgesia after lower third molar surgery: contribution of the use of long-acting local anesthetics, low-power laser, and diclofenac. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Nov;102(5):e4-8. doi: 10.1016/j.tripleo.2006.02.024. Epub 2006 Aug 10.
- Results publication: PubMed 31027098Schalch TO, Palmieri M, Longo PL, Braz-Silva PH, Tortamano IP, Michel-Crosato E, Mayer MPA, Jorge WA, Bussadori SK, Pavani C, Negreiros RM, Horliana ACRT. Evaluation of photodynamic therapy in pericoronitis: Protocol of randomized, controlled, double-blind study. Medicine (Baltimore). 2019 Apr;98(17):e15312. doi: 10.1097/MD.0000000000015312.
- Results publication: PubMed 16876044Kim JC, Choi SS, Wang SJ, Kim SG. Minor complications after mandibular third molar surgery: type, incidence, and possible prevention. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Aug;102(2):e4-11. doi: 10.1016/j.tripleo.2005.10.050. Epub 2006 Jun 27.
- Results publication: PubMed 10625102Monaco G, Staffolani C, Gatto MR, Checchi L. Antibiotic therapy in impacted third molar surgery. Eur J Oral Sci. 1999 Dec;107(6):437-41. doi: 10.1046/j.0909-8836.1999.eos107604.x.
- Results publication: PubMed 19531419Monaco G, Tavernese L, Agostini R, Marchetti C. Evaluation of antibiotic prophylaxis in reducing postoperative infection after mandibular third molar extraction in young patients. J Oral Maxillofac Surg. 2009 Jul;67(7):1467-72. doi: 10.1016/j.joms.2008.12.066.
- Results publication: PubMed 15510357Susarla SM, Dodson TB. Risk factors for third molar extraction difficulty. J Oral Maxillofac Surg. 2004 Nov;62(11):1363-71. doi: 10.1016/j.joms.2004.05.214.
- Results publication: PubMed 11883966Yuasa H, Kawai T, Sugiura M. Classification of surgical difficulty in extracting impacted third molars. Br J Oral Maxillofac Surg. 2002 Feb;40(1):26-31. doi: 10.1054/bjom.2001.0684.
- Results publication: PubMed 12190139Blum IR. Contemporary views on dry socket (alveolar osteitis): a clinical appraisal of standardization, aetiopathogenesis and management: a critical review. Int J Oral Maxillofac Surg. 2002 Jun;31(3):309-17. doi: 10.1054/ijom.2002.0263.
- A comparative analysis of the efficacy of moxifloxacin and cefixime in reduction postoperative inflammatory sequelae after mandibular third molar surgeryLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Branislav V Bajkin, MD, DMD, PhD study chair
Dental Clinic of Vojvodina, Faculty of Medicine, University of Novi Sad
Branimir D Stošić, DMD, PhD study director
University of Novi Sad, Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moxifloxacin 400 mg Oral Tablet and Cefixime 400 mg Oral Tablet in people with Postoperative Complications and Antibiotic Reaction, run by University of Novi Sad at 1 site in Serbia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of postoperative infection at the surgical site (SSI) (time frame: Up to 12 weeks (3 months) after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05027893, which also lists 73 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2022.