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Is Routine Dental Clearance or Antibiotic Prophylaxis Before Dental Procedures Necessary in Total Joint Arthroplasty? A Randomized Controlled Noninferiority Trial

29 oktober 2026 bijgewerkt door: Jennifer Larsen, Creighton University

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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

  1. 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?
  2. 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?

Studietype

Ingrijpend

Inschrijving (Geschat)

3048

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

19 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ander
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Geen tussenkomst: 1. Obtains dental clearance and undergoes routine antibiotic prophylaxis
  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
Experimenteel: 2. Omits dental clearance and undergoes routine antibiotic prophylaxis
  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.
Ander: Dental Clearance and Routine Antibiotic Prophylaxis

Dental Clearance Group Participants will undergo standardized preoperative dental evaluation. Any dental treatment recommended by the treating dental provider must be completed prior to surgery, with written clearance documented before proceeding.

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.
Experimenteel: 3. Obtains dental clearance and omits routine antibiotic prophylaxis
  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.
Ander: Dental Clearance and Routine Antibiotic Prophylaxis

Dental Clearance Group Participants will undergo standardized preoperative dental evaluation. Any dental treatment recommended by the treating dental provider must be completed prior to surgery, with written clearance documented before proceeding.

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.
Experimenteel: 4. Omits dental clearance and routine antibiotic prophylaxis
  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.
Ander: Dental Clearance and Routine Antibiotic Prophylaxis

Dental Clearance Group Participants will undergo standardized preoperative dental evaluation. Any dental treatment recommended by the treating dental provider must be completed prior to surgery, with written clearance documented before proceeding.

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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Periprosthetic joint infection (PJI) within 12 months, defined using Musculoskeletal Infection Society criteria (Parvizi, et al).
Tijdsspanne: 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.
12 Months

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
• Periprosthetic joint infection at 24, 36, 48, 60 and 120 months, defined using Musculoskeletal Infection Society criteria (Parvizi, et al).
Tijdsspanne: 120 months

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).
120 months
• Time from scheduling to surgery (i.e. delay caused by dental clearance)
Tijdsspanne: 3-5 years

1. To compare time from surgical scheduling to operative date.
3-5 years
• Rate of patients requiring dental procedure before getting dental clearance
Tijdsspanne: 3-5 years

2. To determine the rate of dental intervention in patients requiring clearance.
3-5 years
• Number of reoperations and which procedure is performed for PJI.
Tijdsspanne: 3-5 years

3. To compare reoperation and revision arthroplasty rates for infection.
3-5 years
• Causative organisms of PJI
Tijdsspanne: 3-5 years

4. To characterize microbiologic profiles of PJIs.
3-5 years

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Creighton University

Medewerkers

CommonSpirit Health

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

15 december 2026

Primaire voltooiing (Geschat)

1 januari 2031

Studie voltooiing (Geschat)

1 juli 2032

Studieregistratiedata

Eerst ingediend

29 oktober 2026

Eerst ingediend dat voldeed aan de QC-criteria

29 oktober 2026

Eerst geplaatst (Werkelijk)

4 november 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

4 november 2026

Laatste update ingediend die voldeed aan QC-criteria

29 oktober 2026

Laatst geverifieerd

1 oktober 2026

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • CommonSpirit IRB 2447281-1

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

Results will otherwise be disseminated through academic journals as well as poster or podium presentations at academic meetings.

IPD delen Ondersteunend informatietype

  • SAP

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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