Maxillofacial SurgeryPhase 3NCT02764710
Randomized Controlled Trial Comparing Long and Short Duration of Antibiotic Prophylaxis for Patients Undergoing Sinus Lift Surgery
A Phase 3 study testing Amoxicillin-Potassium Clavulanate Combination in people with Maxillofacial Surgery, run by Tel-Aviv Sourasky Medical Center.
Trial summary
The optimal use of prophylactic antibiotic therapy to prevent infection after sinus lift and augmentation surgery is unknown. This is a comparative open label interventional trial comparing a standard 7-day course of postoperative treatment with amoxicillin-clavulanate with short antibiotic treatment for up to 24… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Maxillofacial Surgery
- What is being tested?
- Amoxicillin-Potassium Clavulanate Combination
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- May 2016to May 2018
- Phase
- Phase 3
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patient (18 years of age or older) that requires a unilateral or bilateral sinus augmentation surgery.
- Weight <150 kg.
Who cannot join
- Need for prophylactic antibiotics for infective endocarditis.
- Chronic antibiotics therapy.
- Special populations: pregnant women, minors and legally incompetent patients.
- Patients receiving anticoagulants.
- Non-balanced diabetes mellitus.
- Immune-suppression: corticosteroids treatment equivalent to 15mg prednisone for at least 14 days in the past month; chemotherapy, TNF inhibitor or drugs that suppress T-cell activity during the past 90 days; HIV infection.
Show all 11Show fewer
- Pathology of the maxillary sinus.
- History of chronic sinusitis.
- Patients that underwent a Caldwell-Luc procedure.
- Patients with residual teeth roots at the planned surgical site.
- A known state of carriage of Methicillin resistant Staphylococcus aureus or Clostridium difficile in the past year.
About this study
The optimal use of prophylactic antibiotic therapy to prevent infection after sinus lift and augmentation surgery is unknown. This is a comparative open label interventional trial comparing a standard 7-day course of postoperative treatment with amoxicillin-clavulanate with short antibiotic treatment for up to 24 hours postoperatively. The primary study outcome is the postoperative surgical site infection in the standard versus the short treatment arms. Secondary outcomes are drug-related adverse events and Clostridium difficile infection.
Read the detailed description
Research rational
The use of antibiotics as prophylaxis for surgical site infection (SSI) is well based in most fields of surgery. The use of prophylactic antibiotics can reduce the rate of post-surgical infections substantially. Nonetheless, overuse of these drugs is likely to expose patients to adverse effects, increase the rate of microbial drug resistance and lead to unnecessary expenses.
In the field of dentistry there are recommendations for prevention of infective endocarditis. The use of antibiotics for SSI in the field of oral and maxillofacial surgery is not well established, with inconsistent and even contradictory recommendations.
Sinus floor lift and augmentation is a common surgical procedure in modern dentistry. It aims to increase the amount of bone in the posterior maxilla, in the area of the premolar and molar teeth, prior to placement of dental implants. The procedure is performed in a per-oral approach; a mucoperiosteal flap is elevated, the lateral boney wall of the sinus is exposed and a window is cut with a surgical bur. The Schneiderian membrane (sinus periost) is separated and lifted from the bone and a bone graft material is placed into the newly created space. The graft material used can be an autograft, an allograft, a xenograft, an alloplast or a combination of these materials.
The rate of post-operative infection after a sinus lift procedure reaches 7%. An evidence based approach for antibiotic prophylaxis for this procedure does not exist. The standard of care is based on clinical experience and protocols for placing dental implants in the jaws bone.
The current protocols include broad spectrum antibiotics aimed at oral bacteria and main pathogens in acute bacterial sinusitis (Streptoccocus pneumoniae, Moraxella catarrhalis, Haemophilus influenzae): amoxicillin+clavulanic acid or clindamycin / clarithromycin+metronidazole for patients with penicillin allergy. According to the common protocol, the antibiotics are given one day prior to surgery or at the day of surgery (one hour before the first cut) and are continued for seven days post-operatively. This practice contradicts the current recommendation for a shortened postoperative course of antimicrobials for less than 24 hours (10). No evidence suggests that prescribing antibiotics beyond 24 hours lowers the rate of SSI. On the other hand, a prolonged prophylactic regimen elevates the risk of Clostridium difficile infection and contributes to antibiotic resistance.
Lindenboom and Van den Akker have demonstrated in 2003 that not administrating prophylactic antibiotics at all prior to bone augmentation elevates the rate of SSI significantly in comparison with a patient who receives antibiotics. On the other hand, our clinical experience shows that short term prophylactic antibiotics (up to 3 days post-operatively) in sinus augmentation surgery and other bone augmentations in the oral cavity do not elevate the risk of SSI. The need to prescribe antibiotics for more than 24 hours post-operatively was never evaluated in a clinical trial.
In the current trial we will test the hypothesis that a short prophylactic regimen does not differ from a prolonged one. On the contrary, we hypothesize that the adverse effects rate will be lower in patients that will receive antibiotics for a short period.
Aim of the study
This is a prospective randomized non-blinded trial which compares a short prophylactic regimen (till on day post-operatively) with a long prophylactic regimen (till seven days post-operatively as acceptable currently) in patients that undergo sinus augmentation surgery.
Study hypothesis: both groups will display similar rates of SSIs.
Materials and methods
The participants will be recruited from patients in Tel-Aviv Medical Center dental clinic that are in need for a unilateral or bilateral sinus augmentation surgery.
The recruited patients will meet the chief investigator for a thorough explanation on the trial, emphasizing the fact that the surgery itself is not the essence of this trial. After signing an informed consent for participating in the trial, the patients will be randomly split into two groups. The recruited patients will receive a prescription for antibiotics and how to take them: amoxicillin-clavulanate 875mg twice a day starting at the morning of surgery. Patient with penicillin allergy will receive a loading dose of clindamycin 300mg, followed by 150mg every 6 hours. The duration of treatment (one day or seven days post-operatively) will be determined according to the group attribution.
The sinus augmentation surgeries will be performed by the attending surgeons at the Oral and Maxillofacial department, according to a unified protocol: a pre-op chlorhexidine 2% rinse, local anesthesia with Lidocaine 2% with adrenalin 1:100000, elevation of a mucoperiosteal flap to expose the lateral wall of the sinus, performing an access window in the bony wall and lifting the sinus membrane, augmentation of the cavity using a xenogeneic and /or allogeneic bone graft substitute and a collagen membrane, placement of dental implants if feasible and suturing of the flap.
Augmenting the cavity with different materials reflects the common practice and based on the fact that these differences do not alter the rate of post-operative complications or dental implants failure in sinus augmentation sites.
Further treatment with dexamethasone, decongestants and pain medications will be administered according to current protocols and are subject to the surgeon's judgment in order to reflect the common practice.
The patients will be evaluated at the following appointed times until the placement/exposure of the dental implants: one week, two weeks, one month, two months, six months. These dates are part of the standard of care as a follow-up after sinus augmentation surgery.
Patients will be withdrawn from the study if they will not attend the follow-up appointments.
- Conditions
- Maxillofacial Surgery
- Being tested
- Amoxicillin-Potassium Clavulanate Combination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amoxicillin-Potassium Clavulanate CombinationDrug
Short course of postoperative treatment: amoxicillin-clavulanate 875mg, one tab twice daily for a total of 2 doses.
Long course of postoperative treatment: amoxicillin-clavulanate 875mg, one tab twice daily up until and including postoperative day 7.
| Study group | Role | What they receive |
|---|---|---|
| Short treatment | Experimental | Short course of postoperative treatment: amoxicillin-clavulanate 875mg, one tab twice daily for a total of 2 doses. Receives: Drug: Amoxicillin-Potassium Clavulanate Combination |
| Long treatment | Active comparator | Long course of postoperative treatment: amoxicillin-clavulanate 875mg, one tab twice daily up until and including postoperative day 7. Receives: Drug: Amoxicillin-Potassium Clavulanate Combination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical site infection rate
Deep or superficial SSI according to CDC/NHSN criteria
Measured: 30 days
Secondary outcomes (3)
Diarrhea
Diarrheal illness reported by patient.
Measured: 30 days
Clostridium difficile infection
Laboratory confirmed C. diff. infection
Measured: 30 days
Adverse event rate
Any reported adverse event
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2016 (estimated)
- Study startMay 2016
- Primary completionMay 2018 (estimated)
- Study completionMay 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Maxillofacial SurgeryStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, michal roll, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02764710
- Sponsor's protocol ID
- TASMC-15-RB-0059-CTIL
- Status last verified
- May 2016
- First submitted
- 4 May 2016
- Last updated
- 10 May 2016
- Results posted
- No
Publications
Young PY, Khadaroo RG. Surgical site infections. Surg Clin North Am. 2014 Dec;94(6):1245-64. doi: 10.1016/j.suc.2014.08.008. Epub 2014 Oct 3.
PubMed 25440122Wilson W, Taubert KA, Gewitz M, Lockhart PB, Baddour LM, Levison M, Bolger A, Cabell CH, Takahashi M, Baltimore RS, Newburger JW, Strom BL, Tani LY, Gerber M, Bonow RO, Pallasch T, Shulman ST, Rowley AH, Burns JC, Ferrieri P, Gardner T, Goff D, Durack DT; American Heart Association Rheumatic Fever, Endocarditis, and Kawasaki Disease Committee; American Heart Association Council on Cardiovascular Disease in the Young; American Heart Association Council on Clinical Cardiology; American Heart Association Council on Cardiovascular Surgery and Anesthesia; Quality of Care and Outcomes Research Interdisciplinary Working Group. Prevention of infective endocarditis: guidelines from the American Heart Association: a guideline from the American Heart Association Rheumatic Fever, Endocarditis, and Kawasaki Disease Committee, Council on Cardiovascular Disease in the Young, and the Council on Clinical Cardiology, Council on Cardiovascular Surgery and Anesthesia, and the Quality of Care and Outcomes Research Interdisciplinary Working Group. Circulation. 2007 Oct 9;116(15):1736-54. doi: 10.1161/CIRCULATIONAHA.106.183095. Epub 2007 Apr 19.
PubMed 17446442Anitua E, Aguirre JJ, Gorosabel A, Barrio P, Errazquin JM, Roman P, Pla R, Carrete J, de Petro J, Orive G. A multicentre placebo-controlled randomised clinical trial of antibiotic prophylaxis for placement of single dental implants. Eur J Oral Implantol. 2009 Winter;2(4):283-92.
PubMed 20467604Mazzocchi A, Passi L, Moretti R. Retrospective analysis of 736 implants inserted without antibiotic therapy. J Oral Maxillofac Surg. 2007 Nov;65(11):2321-3. doi: 10.1016/j.joms.2007.06.620.
PubMed 17954332Laskin DM, Dent CD, Morris HF, Ochi S, Olson JW. The influence of preoperative antibiotics on success of endosseous implants at 36 months. Ann Periodontol. 2000 Dec;5(1):166-74. doi: 10.1902/annals.2000.5.1.166.
PubMed 11885177Choukroun J, Simonpieri A, Del Corso M, Mazor Z, Sammartino G, Dohan Ehrenfest DM. Controlling systematic perioperative anaerobic contamination during sinus-lift procedures by using metronidazole: an innovative approach. Implant Dent. 2008 Sep;17(3):257-70. doi: 10.1097/ID.0b013e318181349a.
PubMed 18784526Testori T, Drago L, Wallace SS, Capelli M, Galli F, Zuffetti F, Parenti A, Deflorian M, Fumagalli L, Weinstein RL, Maiorana C, Di Stefano D, Valentini P, Gianni AB, Chiapasco M, Vinci R, Pignataro L, Mantovani M, Torretta S, Pipolo C, Felisati G, Padoan G, Castelnuovo P, Mattina R, Del Fabbro M. Prevention and treatment of postoperative infections after sinus elevation surgery: clinical consensus and recommendations. Int J Dent. 2012;2012:365809. doi: 10.1155/2012/365809. Epub 2012 Aug 9.
PubMed 22927851Esposito M, Cannizzaro G, Bozzoli P, Checchi L, Ferri V, Landriani S, Leone M, Todisco M, Torchio C, Testori T, Galli F, Felice P. Effectiveness of prophylactic antibiotics at placement of dental implants: a pragmatic multicentre placebo-controlled randomised clinical trial. Eur J Oral Implantol. 2010 Summer;3(2):135-43.
PubMed 20623038Esposito M, Grusovin MG, Loli V, Coulthard P, Worthington HV. Does antibiotic prophylaxis at implant placement decrease early implant failures? A Cochrane systematic review. Eur J Oral Implantol. 2010 Summer;3(2):101-10.
PubMed 20623035Bratzler DW, Dellinger EP, Olsen KM, Perl TM, Auwaerter PG, Bolon MK, Fish DN, Napolitano LM, Sawyer RG, Slain D, Steinberg JP, Weinstein RA; American Society of Health-System Pharmacists; Infectious Disease Society of America; Surgical Infection Society; Society for Healthcare Epidemiology of America. Clinical practice guidelines for antimicrobial prophylaxis in surgery. Am J Health Syst Pharm. 2013 Feb 1;70(3):195-283. doi: 10.2146/ajhp120568. No abstract available.
PubMed 23327981Cohen SH, Gerding DN, Johnson S, Kelly CP, Loo VG, McDonald LC, Pepin J, Wilcox MH; Society for Healthcare Epidemiology of America; Infectious Diseases Society of America. Clinical practice guidelines for Clostridium difficile infection in adults: 2010 update by the society for healthcare epidemiology of America (SHEA) and the infectious diseases society of America (IDSA). Infect Control Hosp Epidemiol. 2010 May;31(5):431-55. doi: 10.1086/651706.
PubMed 20307191Lindeboom JA, van den Akker HP. A prospective placebo-controlled double-blind trial of antibiotic prophylaxis in intraoral bone grafting procedures: a pilot study. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2003 Dec;96(6):669-72. doi: 10.1016/j.tripleo.2003.08.026.
PubMed 14676756Herzberg R, Dolev E, Schwartz-Arad D. Implant marginal bone loss in maxillary sinus grafts. Int J Oral Maxillofac Implants. 2006 Jan-Feb;21(1):103-10.
PubMed 16519188Horan TC, Andrus M, Dudeck MA. CDC/NHSN surveillance definition of health care-associated infection and criteria for specific types of infections in the acute care setting. Am J Infect Control. 2008 Jun;36(5):309-32. doi: 10.1016/j.ajic.2008.03.002. No abstract available.
PubMed 18538699
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Comparing Long and Short Duration of Antibiotic Prophylaxis for Patients Undergoing Sinus Lift Surgery
- ClinicalTrials.gov ID
- NCT02764710
- Acronym / sponsor ID
- TASMC-15-RB-0059-CTIL
- Conditions
- Maxillofacial Surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- May 2016
- Primary completion
- May 2018 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 6 May 2016 (estimated)
- 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.
The optimal use of prophylactic antibiotic therapy to prevent infection after sinus lift and augmentation surgery is unknown. This is a comparative open label interventional trial comparing a standard 7-day course of postoperative treatment with amoxicillin-clavulanate with short antibiotic treatment for up to 24 hours postoperatively. The primary study outcome is the postoperative surgical site infection in the standard versus the short treatment arms. Secondary outcomes are drug-related adverse events and Clostridium difficile infection.
Detailed description
Research rational
The use of antibiotics as prophylaxis for surgical site infection (SSI) is well based in most fields of surgery. The use of prophylactic antibiotics can reduce the rate of post-surgical infections substantially. Nonetheless, overuse of these drugs is likely to expose patients to adverse effects, increase the rate of microbial drug resistance and lead to unnecessary expenses.
In the field of dentistry there are recommendations for prevention of infective endocarditis. The use of antibiotics for SSI in the field of oral and maxillofacial surgery is not well established, with inconsistent and even contradictory recommendations.
Sinus floor lift and augmentation is a common surgical procedure in modern dentistry. It aims to increase the amount of bone in the posterior maxilla, in the area of the premolar and molar teeth, prior to placement of dental implants. The procedure is performed in a per-oral approach; a mucoperiosteal flap is elevated, the lateral boney wall of the sinus is exposed and a window is cut with a surgical bur. The Schneiderian membrane (sinus periost) is separated and lifted from the bone and a bone graft material is placed into the newly created space. The graft material used can be an autograft, an allograft, a xenograft, an alloplast or a combination of these materials.
The rate of post-operative infection after a sinus lift procedure reaches 7%. An evidence based approach for antibiotic prophylaxis for this procedure does not exist. The standard of care is based on clinical experience and protocols for placing dental implants in the jaws bone.
The current protocols include broad spectrum antibiotics aimed at oral bacteria and main pathogens in acute bacterial sinusitis (Streptoccocus pneumoniae, Moraxella catarrhalis, Haemophilus influenzae): amoxicillin+clavulanic acid or clindamycin / clarithromycin+metronidazole for patients with penicillin allergy. According to the common protocol, the antibiotics are given one day prior to surgery or at the day of surgery (one hour before the first cut) and are continued for seven days post-operatively. This practice contradicts the current recommendation for a shortened postoperative course of antimicrobials for less than 24 hours (10). No evidence suggests that prescribing antibiotics beyond 24 hours lowers the rate of SSI. On the other hand, a prolonged prophylactic regimen elevates the risk of Clostridium difficile infection and contributes to antibiotic resistance.
Lindenboom and Van den Akker have demonstrated in 2003 that not administrating prophylactic antibiotics at all prior to bone augmentation elevates the rate of SSI significantly in comparison with a patient who receives antibiotics. On the other hand, our clinical experience shows that short term prophylactic antibiotics (up to 3 days post-operatively) in sinus augmentation surgery and other bone augmentations in the oral cavity do not elevate the risk of SSI. The need to prescribe antibiotics for more than 24 hours post-operatively was never evaluated in a clinical trial.
In the current trial we will test the hypothesis that a short prophylactic regimen does not differ from a prolonged one. On the contrary, we hypothesize that the adverse effects rate will be lower in patients that will receive antibiotics for a short period.
Aim of the study
This is a prospective randomized non-blinded trial which compares a short prophylactic regimen (till on day post-operatively) with a long prophylactic regimen (till seven days post-operatively as acceptable currently) in patients that undergo sinus augmentation surgery.
Study hypothesis: both groups will display similar rates of SSIs.
Materials and methods
The participants will be recruited from patients in Tel-Aviv Medical Center dental clinic that are in need for a unilateral or bilateral sinus augmentation surgery.
The recruited patients will meet the chief investigator for a thorough explanation on the trial, emphasizing the fact that the surgery itself is not the essence of this trial. After signing an informed consent for participating in the trial, the patients will be randomly split into two groups. The recruited patients will receive a prescription for antibiotics and how to take them: amoxicillin-clavulanate 875mg twice a day starting at the morning of surgery. Patient with penicillin allergy will receive a loading dose of clindamycin 300mg, followed by 150mg every 6 hours. The duration of treatment (one day or seven days post-operatively) will be determined according to the group attribution.
The sinus augmentation surgeries will be performed by the attending surgeons at the Oral and Maxillofacial department, according to a unified protocol: a pre-op chlorhexidine 2% rinse, local anesthesia with Lidocaine 2% with adrenalin 1:100000, elevation of a mucoperiosteal flap to expose the lateral wall of the sinus, performing an access window in the bony wall and lifting the sinus membrane, augmentation of the cavity using a xenogeneic and /or allogeneic bone graft substitute and a collagen membrane, placement of dental implants if feasible and suturing of the flap.
Augmenting the cavity with different materials reflects the common practice and based on the fact that these differences do not alter the rate of post-operative complications or dental implants failure in sinus augmentation sites.
Further treatment with dexamethasone, decongestants and pain medications will be administered according to current protocols and are subject to the surgeon's judgment in order to reflect the common practice.
The patients will be evaluated at the following appointed times until the placement/exposure of the dental implants: one week, two weeks, one month, two months, six months. These dates are part of the standard of care as a follow-up after sinus augmentation surgery.
Patients will be withdrawn from the study if they will not attend the follow-up appointments.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short treatment | Experimental | Drug: Amoxicillin-Potassium Clavulanate CombinationShort course of postoperative treatment: amoxicillin-clavulanate 875mg, one tab twice daily for a total of 2 doses. |
| Long treatment | Active comparator | Drug: Amoxicillin-Potassium Clavulanate CombinationLong course of postoperative treatment: amoxicillin-clavulanate 875mg, one tab twice daily up until and including postoperative day 7. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patient (18 years of age or older) that requires a unilateral or bilateral sinus augmentation surgery.
- Weight <150 kg.
Key exclusion criteria (11 listed)
- Need for prophylactic antibiotics for infective endocarditis.
- Chronic antibiotics therapy.
- Special populations: pregnant women, minors and legally incompetent patients.
- Patients receiving anticoagulants.
- Non-balanced diabetes mellitus.
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 |
|---|---|---|
| Amoxicillin-Potassium Clavulanate CombinationShort course of postoperative treatment: amoxicillin-clavulanate 875mg, one tab twice daily for a total of 2 doses. Long course of postoperative treatment: amoxicillin-clavulanate 875mg, one tab twice daily up until and including postoperative day 7. | Drug | Long treatment, Short treatment |
Primary outcome
Surgical site infection rate
Time frame: 30 days
Deep or superficial SSI according to CDC/NHSN criteria
3 secondary outcomes
Diarrhea
Time frame: 30 days
Clostridium difficile infection
Time frame: 30 days
Adverse event rate
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2016.
- Background: PubMed 25440122Young PY, Khadaroo RG. Surgical site infections. Surg Clin North Am. 2014 Dec;94(6):1245-64. doi: 10.1016/j.suc.2014.08.008. Epub 2014 Oct 3.
- Background: PubMed 17446442Wilson W, Taubert KA, Gewitz M, Lockhart PB, Baddour LM, Levison M, Bolger A, Cabell CH, Takahashi M, Baltimore RS, Newburger JW, Strom BL, Tani LY, Gerber M, Bonow RO, Pallasch T, Shulman ST, Rowley AH, Burns JC, Ferrieri P, Gardner T, Goff D, Durack DT; American Heart Association Rheumatic Fever, Endocarditis, and Kawasaki Disease Committee; American Heart Association Council on Cardiovascular Disease in the Young; American Heart Association Council on Clinical Cardiology; American Heart Association Council on Cardiovascular Surgery and Anesthesia; Quality of Care and Outcomes Research Interdisciplinary Working Group. Prevention of infective endocarditis: guidelines from the American Heart Association: a guideline from the American Heart Association Rheumatic Fever, Endocarditis, and Kawasaki Disease Committee, Council on Cardiovascular Disease in the Young, and the Council on Clinical Cardiology, Council on Cardiovascular Surgery and Anesthesia, and the Quality of Care and Outcomes Research Interdisciplinary Working Group. Circulation. 2007 Oct 9;116(15):1736-54. doi: 10.1161/CIRCULATIONAHA.106.183095. Epub 2007 Apr 19.
- Background: PubMed 20467604Anitua E, Aguirre JJ, Gorosabel A, Barrio P, Errazquin JM, Roman P, Pla R, Carrete J, de Petro J, Orive G. A multicentre placebo-controlled randomised clinical trial of antibiotic prophylaxis for placement of single dental implants. Eur J Oral Implantol. 2009 Winter;2(4):283-92.
- Background: PubMed 17954332Mazzocchi A, Passi L, Moretti R. Retrospective analysis of 736 implants inserted without antibiotic therapy. J Oral Maxillofac Surg. 2007 Nov;65(11):2321-3. doi: 10.1016/j.joms.2007.06.620.
- Background: PubMed 11885177Laskin DM, Dent CD, Morris HF, Ochi S, Olson JW. The influence of preoperative antibiotics on success of endosseous implants at 36 months. Ann Periodontol. 2000 Dec;5(1):166-74. doi: 10.1902/annals.2000.5.1.166.
- Background: PubMed 18784526Choukroun J, Simonpieri A, Del Corso M, Mazor Z, Sammartino G, Dohan Ehrenfest DM. Controlling systematic perioperative anaerobic contamination during sinus-lift procedures by using metronidazole: an innovative approach. Implant Dent. 2008 Sep;17(3):257-70. doi: 10.1097/ID.0b013e318181349a.
- Background: PubMed 22927851Testori T, Drago L, Wallace SS, Capelli M, Galli F, Zuffetti F, Parenti A, Deflorian M, Fumagalli L, Weinstein RL, Maiorana C, Di Stefano D, Valentini P, Gianni AB, Chiapasco M, Vinci R, Pignataro L, Mantovani M, Torretta S, Pipolo C, Felisati G, Padoan G, Castelnuovo P, Mattina R, Del Fabbro M. Prevention and treatment of postoperative infections after sinus elevation surgery: clinical consensus and recommendations. Int J Dent. 2012;2012:365809. doi: 10.1155/2012/365809. Epub 2012 Aug 9.
- Background: PubMed 20623038Esposito M, Cannizzaro G, Bozzoli P, Checchi L, Ferri V, Landriani S, Leone M, Todisco M, Torchio C, Testori T, Galli F, Felice P. Effectiveness of prophylactic antibiotics at placement of dental implants: a pragmatic multicentre placebo-controlled randomised clinical trial. Eur J Oral Implantol. 2010 Summer;3(2):135-43.
- Background: PubMed 20623035Esposito M, Grusovin MG, Loli V, Coulthard P, Worthington HV. Does antibiotic prophylaxis at implant placement decrease early implant failures? A Cochrane systematic review. Eur J Oral Implantol. 2010 Summer;3(2):101-10.
- Background: PubMed 23327981Bratzler DW, Dellinger EP, Olsen KM, Perl TM, Auwaerter PG, Bolon MK, Fish DN, Napolitano LM, Sawyer RG, Slain D, Steinberg JP, Weinstein RA; American Society of Health-System Pharmacists; Infectious Disease Society of America; Surgical Infection Society; Society for Healthcare Epidemiology of America. Clinical practice guidelines for antimicrobial prophylaxis in surgery. Am J Health Syst Pharm. 2013 Feb 1;70(3):195-283. doi: 10.2146/ajhp120568. No abstract available.
- Background: PubMed 20307191Cohen SH, Gerding DN, Johnson S, Kelly CP, Loo VG, McDonald LC, Pepin J, Wilcox MH; Society for Healthcare Epidemiology of America; Infectious Diseases Society of America. Clinical practice guidelines for Clostridium difficile infection in adults: 2010 update by the society for healthcare epidemiology of America (SHEA) and the infectious diseases society of America (IDSA). Infect Control Hosp Epidemiol. 2010 May;31(5):431-55. doi: 10.1086/651706.
- Background: PubMed 14676756Lindeboom JA, van den Akker HP. A prospective placebo-controlled double-blind trial of antibiotic prophylaxis in intraoral bone grafting procedures: a pilot study. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2003 Dec;96(6):669-72. doi: 10.1016/j.tripleo.2003.08.026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Amoxicillin-Potassium Clavulanate Combination in people with Maxillofacial Surgery, run by Tel-Aviv Sourasky Medical Center.
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 2 inclusion and 11 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 10 May 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Surgical site infection rate (time frame: 30 days). 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 NCT02764710, which also lists 14 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 10 May 2016; AzTrials last refreshed its copy on 6 Nov 2026.