Elective Primary THA or TKANCT07917533
Is Routine Dental Clearance or Antibiotic Prophylaxis Before Dental Procedures Necessary in Total Joint Arthroplasty?
A study testing No Dental Clearance Group, Routine Antibiotic Prophylaxis Group and No Antibiotic Prophylaxis Group in people with Elective Primary THA or TKA, run by Creighton University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Elective Primary THA or TKA
- What is being tested?
- No Dental Clearance Group, Routine Antibiotic Prophylaxis Group and No Antibiotic Prophylaxis Group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,048 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2026to 1 Jul 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥19 years (19 is age of majority in Nebraska)
- Scheduled for elective primary THA or TKA (i.e. no revision or conversion procedures)
- Ability to provide informed consent
Who cannot join
- Revision arthroplasty
- Arthroplasty for fracture or performed urgently (i.e. incomplete work up)
- Active or previous infection of the operative joint
- Active systemic infection
- On chronic antibiotic therapy
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Is Routine Dental Clearance or Antibiotic Prophylaxis Before Dental Procedures Necessary in Total Joint Arthroplasty? A Randomized Controlled Noninferiority Trial
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.
Read the detailed description
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
- Is omission of routine preoperative dental clearance non-inferior to mandatory dental clearance with respect to prosthetic joint infection risk following elective primary hip or knee arthroplasty?
- Is omission of routine postoperative antibiotic prophylaxis non-inferior to prescription of routine antibiotic prophylaxis with respect to prosthetic joint infection risk following elective primary hip or knee arthroplasty?
- Conditions
- Elective Primary THA or TKA
- Being tested
- No Dental Clearance Group, Routine Antibiotic Prophylaxis Group, No Antibiotic Prophylaxis Group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Dental Clearance GroupOther
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 GroupOther
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 GroupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 1. Obtains dental clearance and undergoes routine antibiotic prophylaxis | No intervention | 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 |
| 2. Omits dental clearance and undergoes routine antibiotic prophylaxis | Experimental | 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. Receives: Other: No Dental Clearance Group |
| 3. Obtains dental clearance and omits routine antibiotic prophylaxis | Experimental | 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. Receives: Other: Routine Antibiotic Prophylaxis Group |
| 4. Omits dental clearance and routine antibiotic prophylaxis | Experimental | 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. Receives: Other: No Antibiotic Prophylaxis Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Periprosthetic joint infection (PJI) within 12 months, defined using Musculoskeletal Infection Society (MSIS) criteria.
- 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.
Measured: 12 Months
Secondary outcomes (5)
• Periprosthetic joint infection at 24, 36, 48, 60 and 120 months, defined using Musculoskeletal Infection Society (MSIS) criteria.
- 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.
Measured: 120 months
• Time from scheduling to surgery (i.e. delay caused by dental clearance)
- To compare time from surgical scheduling to operative date.
Measured: 3-5 years
• Rate of patients requiring dental procedure before getting dental clearance
- To determine the rate of dental intervention in patients requiring clearance.
Measured: 3-5 years
• Number of reoperations and which procedure is performed for PJI.
- To compare reoperation and revision arthroplasty rates for infection.
Measured: 3-5 years
• Causative organisms of PJI
- To characterize microbiologic profiles of PJIs.
Measured: 3-5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start15 Dec 2026 (estimated)
- Primary completion1 Jan 2031 (estimated)
- Study completion1 Jul 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elective Primary THA or TKAStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 3,048 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Creighton University
- Sponsor type
- University, hospital or other
- Collaborators
- CommonSpirit Health
- Responsible party
- Principal investigator, Jennifer Larsen, Creighton University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07917533
- Sponsor's protocol ID
- CommonSpirit IRB 2447281-1
- Status last verified
- Nov 2026
- First submitted
- 29 Oct 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Results will otherwise be disseminated through academic journals as well as poster or podium presentations at academic meetings.
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Routine Dental Clearance or Antibiotic Prophylaxis Before Dental Procedures Necessary in Total Joint Arthroplasty? A Randomized Controlled Noninferiority Trial
- ClinicalTrials.gov ID
- NCT07917533
- Acronym / sponsor ID
- CommonSpirit IRB 2447281-1
- Conditions
- Elective Primary THA or TKA
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 3,048 participants (estimated)
- Lead sponsor
- Creighton UniversityUniversity, hospital or other
- Collaborators
- CommonSpirit Health
- Study start
- 15 Dec 2026 (estimated)
- Primary completion
- 1 Jan 2031 (estimated)
- Study completion
- 1 Jul 2032 (estimated)
- First posted
- 4 Nov 2026 (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.
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.
Detailed description
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
- Is omission of routine preoperative dental clearance non-inferior to mandatory dental clearance with respect to prosthetic joint infection risk following elective primary hip or knee arthroplasty?
- Is omission of routine postoperative antibiotic prophylaxis non-inferior to prescription of routine antibiotic prophylaxis with respect to prosthetic joint infection risk following elective primary hip or knee arthroplasty?
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1. Obtains dental clearance and undergoes routine antibiotic prophylaxis | No intervention | –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 |
| 2. Omits dental clearance and undergoes routine antibiotic prophylaxis | Experimental | Other: No Dental Clearance Group1. 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. |
| 3. Obtains dental clearance and omits routine antibiotic prophylaxis | Experimental | Other: Routine Antibiotic Prophylaxis Group1. 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. |
| 4. Omits dental clearance and routine antibiotic prophylaxis | Experimental | Other: No Antibiotic Prophylaxis Group1. 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥19 years (19 is age of majority in Nebraska)
- Scheduled for elective primary THA or TKA (i.e. no revision or conversion procedures)
- Ability to provide informed consent
Key exclusion criteria (6 listed)
- Revision arthroplasty
- Arthroplasty for fracture or performed urgently (i.e. incomplete work up)
- Active or previous infection of the operative joint
- Active systemic infection
- On chronic antibiotic therapy
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 |
|---|---|---|
| No Dental Clearance GroupNo 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. | Other | 2. Omits dental clearance and undergoes routine antibiotic prophylaxis |
| Routine Antibiotic Prophylaxis GroupRoutine 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 | Other | 3. Obtains dental clearance and omits routine antibiotic prophylaxis |
| No Antibiotic Prophylaxis GroupNo 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. | Other | 4. Omits dental clearance and routine antibiotic prophylaxis |
Primary outcome
Periprosthetic joint infection (PJI) within 12 months, defined using Musculoskeletal Infection Society (MSIS) criteria.
Time frame: 12 Months
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.
5 secondary outcomes
• Periprosthetic joint infection at 24, 36, 48, 60 and 120 months, defined using Musculoskeletal Infection Society (MSIS) criteria.
Time frame: 120 months
• Time from scheduling to surgery (i.e. delay caused by dental clearance)
Time frame: 3-5 years
• Rate of patients requiring dental procedure before getting dental clearance
Time frame: 3-5 years
• Number of reoperations and which procedure is performed for PJI.
Time frame: 3-5 years
• Causative organisms of PJI
Time frame: 3-5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: Yes. Results will otherwise be disseminated through academic journals as well as poster or podium presentations at academic meetings.
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.
Questions about this trial
What is this clinical trial studying?
A study testing No Dental Clearance Group, Routine Antibiotic Prophylaxis Group and No Antibiotic Prophylaxis Group in people with Elective Primary THA or TKA, run by Creighton University.
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 3 inclusion and 6 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: opening soon, as of the sponsor's last update on 6 Nov 2026. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact John Green, MD (402-717-0820, JohnGreen1@creighton.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Periprosthetic joint infection (PJI) within 12 months, defined using Musculoskeletal Infection Society (MSIS) criteria. (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Nov 2026.