An interventional study of No Dental Clearance Group and Routine Antibiotic Prophylaxis Group in Elective Primary THA or TKA, sponsored by Creighton University. Not yet recruiting. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Creighton University · Not applicable, Interventional, and Other
This study is a prospective, randomized, controlled, noninferiority trial with parallel assignment that will afford simultaneous assessment of the omission of dental clearance and the omission of post-operative antibiotics for dental procedures.
A noninferiority design is chosen because elimination of a preoperative requirement may offer substantial benefits in cost, access, and timeliness of care; provided infection risk is not meaningfully increased.
Study Questions
Creighton University is the lead sponsor of 129 studies on the registry; 6 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
All patients who meet the above criteria will be offered inclusion in the study either at their pre-operative clinic visit or over the phone.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
1. This is the current standard of care. 2. Dental clearance involves a dental exam. If any abnormalities are noted, then additional procedures are performed at the dentist's discretion before proceeding with hip or knee arthroplasty. 3. Once dental clearance is obtained, then patient proceeds to surgery 4. Post-operatively, the patients receive antibiotic prophylaxis prior to any dental
1. Routine dental clearance will be omitted and the patient will proceed to surgery without dental clearance. 2. The joint arthroplasty will otherwise be performed according to the standard practice of the surgeon, already designed to minimize risk to the patient, including risk of PJI. 3. Post-operatively, the patients receive antibiotic prophylaxis prior to any dental procedures/cleanings for a duration of 2 years.
Other: No Dental Clearance Group
1. Dental clearance involves a dental exam. If any abnormalities are noted, then additional procedures are performed at the dentist's discretion before proceeding with hip or knee arthroplasty. 2. Once dental clearance is obtained, then patient proceeds to surgery 3. Post-operatively, the patient does not receive routine antibiotic prophylaxis before dental procedures.
Other: Routine Antibiotic Prophylaxis Group
1. Routine dental clearance will be omitted and the patient will proceed to surgery without dental clearance. 2. The joint arthroplasty will otherwise be performed according to the standard practice of the surgeon, already designed to minimize risk to the patient, including risk of PJI. 3. Post-operatively, the patient does not receive routine antibiotic prophylaxis before dental procedures.
Other: No Antibiotic Prophylaxis Group
No Dental Clearance Group Participants will proceed directly to arthroplasty without mandatory dental evaluation. Acute dental symptoms arising preoperatively will be managed according to standard clinical practice.
Routine Antibiotic Prophylaxis Group Participants will receive antibiotic prophylaxis before every dental procedure, including routine cleanings: * Amoxicillin 2 g orally 30-60 minutes prior * Clindamycin 600 mg orally for penicillin allergy
No Antibiotic Prophylaxis Group Participants will receive no routine antibiotic prophylaxis prior to any dental procedure, including cleanings. All other dental care will proceed per standard practice.
Periprosthetic joint infection (PJI) within 12 months, defined using Musculoskeletal Infection Society (MSIS) criteria.
1\. To determine whether omission of routine preoperative dental clearance is non-inferior to mandatory dental clearance in preventing periprosthetic joint infection within 12 months following primary TJA. MSIS Criteria: Major\*: Communicating sinus tract, or Isolated organism in two different tissue/fluid cultures. Minor\*\*: Elevated ESR/CRP, Elevated synovial leukocyte count, Elevated synovial PMN%, Purulent material, Isolated organism in one tissue/fluid culture, \> 5 neutrophils per hpf in 5 hpf histologic tissue analysis ✕400 magnification. \*1 criterion is needed to establish diagnosis of prosthetic joint infection \*\*4 out of 6 minor criteria are needed to establish diagnosis of prosthetic joint infection. CRP, C-reactive protein; ESR, erythrocyte sedimentation rate; hpf, high-power field; PMN%, polymorphonuclear neutrophil percentage.
Time frame: 12 Months
• Periprosthetic joint infection at 24, 36, 48, 60 and 120 months, defined using Musculoskeletal Infection Society (MSIS) criteria.
5\. To determine whether the omission of dental clearance or omission of routine dental clearance is non-inferior to routine use of these perioperatively at longer term follow up (2, 5 and 10 years). MSIS Criteria: Major\*: Communicating sinus tract, or Isolated organism in two different tissue/fluid cultures. Minor\*\*: Elevated ESR/CRP, Elevated synovial leukocyte count, Elevated synovial PMN%, Purulent material, Isolated organism in one tissue/fluid culture, \> 5 neutrophils per hpf in 5 hpf histologic tissue analysis ✕400 magnification. \*1 criterion is needed to establish diagnosis of prosthetic joint infection \*\*4 out of 6 minor criteria are needed to establish diagnosis of prosthetic joint infection. CRP, C-reactive protein; ESR, erythrocyte sedimentation rate; hpf, high-power field; PMN%, polymorphonuclear neutrophil percentage.
Time frame: 120 months
• Time from scheduling to surgery (i.e. delay caused by dental clearance)
1\. To compare time from surgical scheduling to operative date.
Time frame: 3-5 years
• Rate of patients requiring dental procedure before getting dental clearance
2\. To determine the rate of dental intervention in patients requiring clearance.
Time frame: 3-5 years
• Number of reoperations and which procedure is performed for PJI.
3\. To compare reoperation and revision arthroplasty rates for infection.
Time frame: 3-5 years
• Causative organisms of PJI
4\. To characterize microbiologic profiles of PJIs.
Time frame: 3-5 years
No study locations are listed for this record.
Plan to share: Yes — Results will otherwise be disseminated through academic journals as well as poster or podium presentations at academic meetings.
Supporting information: Statistical analysis plan
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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