Is Routine Dental Clearance or Antibiotic Prophylaxis Before Dental Procedures Necessary in Total Joint Arthroplasty?
NCT07917533, Not applicable, Not yet recruiting, Creighton University
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Is Routine Dental Clearance or Antibiotic Prophylaxis Before Dental Procedures Necessary in Total Joint Arthroplasty? | ClinicalTrials.gov |
| NCT number | NCT07917533 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 3,048 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Creighton University | ClinicalTrials.gov |
| Conditions | Elective Primary THA or TKA | ClinicalTrials.gov |
| Interventions | No Dental Clearance Group, Routine Antibiotic Prophylaxis Group, No Antibiotic Prophylaxis Group | ClinicalTrials.gov |
| First posted | 2026-11-04 | ClinicalTrials.gov |
| Last updated | 2026-11-06 | ClinicalTrials.gov |
Registered outcomes 6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Periprosthetic joint infection (PJI) within 12 months, defined using Musculoskeletal Infection Society (MSIS) criteria. | 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. | ClinicalTrials.gov |
| Secondary | • Periprosthetic joint infection at 24, 36, 48, 60 and 120 months, defined using Musculoskeletal Infection Society (MSIS) criteria. | 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). 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. | ClinicalTrials.gov |
| Secondary | • Time from scheduling to surgery (i.e. delay caused by dental clearance) | 3-5 years | 1\. To compare time from surgical scheduling to operative date. | ClinicalTrials.gov |
| Secondary | • Rate of patients requiring dental procedure before getting dental clearance | 3-5 years | 2\. To determine the rate of dental intervention in patients requiring clearance. | ClinicalTrials.gov |
| Secondary | • Number of reoperations and which procedure is performed for PJI. | 3-5 years | 3\. To compare reoperation and revision arthroplasty rates for infection. | ClinicalTrials.gov |
| Secondary | • Causative organisms of PJI | 3-5 years | 4\. To characterize microbiologic profiles of PJIs. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
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Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
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Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)