ACTRN12624001151527Not yet recruitingPhase 4
Effects of antibiotic prophylaxis on rates of early implant failure in dental implant surgery for adult patients: Randomized controlled clinical trial.
Master in Oral Surgery and Implantology, University of Granada0 sites100 target enrollmentStarted: September 23, 2024Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 100
- Primary Endpoint
- Early implant failure[Defined by removal of the implant before prosthetic loading. <br>Patient clinic review at 7 days, 14 days, 30 days and 90 days. If early implant failure occurs outside of these periods, the patient will go to the faculty's operating room. Baseline, 7 days, 14 days, 30 days, 90 days<br>]
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Treatment
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 18 Years to No limit (—)
- Sex
- All
Inclusion Criteria
- •Patients 18 years and over• Subjects treated periodontally, if necessary, prior to placementof implants• Presence of sufficient bone and soft tissue that does not imply augmentation surgery in the moment of implant placement• Implants placed in a single surgical field
Exclusion Criteria
- •Patients who, due to their medical condition, require antibiotic prophylaxispostoperative (risk of endocarditis)• Patients undergoing head and neck radiotherapy less than 2 years ago• Diabetics (controlled and uncontrolled)• Allergic to penicillin• Patients treated with antiresorptive drugs• Pregnant or breastfeeding• Immunocompromised• Patients who are taking antibiotics for other reasons• Implants that require simultaneous bone regeneration• Implants in which immediate loading is carried out• Immediate implants
Outcomes
Primary Outcomes
Early implant failure[Defined by removal of the implant before prosthetic loading. <br>Patient clinic review at 7 days, 14 days, 30 days and 90 days. If early implant failure occurs outside of these periods, the patient will go to the faculty's operating room. Baseline, 7 days, 14 days, 30 days, 90 days<br>]
Secondary Outcomes
- Presence of postoperatory infection [Postoperative pain and inflammation were evaluated daily on days 1 to 7 post-surgery using a VAS (0= no pain/swelling to 10=maximum imaginable pain/swelling), also recording the amount of anti-inflammatory/analgesic rescue medication taken each day. Presence of infection in the next control appointment (14 days, 30 days, 90 days). Baseline, days 1-7, 14 days, 30 days, 90 days post-surgery. ];Implant stability quotient (ISQ) values for primary and secondary implant stability[ISQ measured on the surgery day, and in day 90. baseline (surgery day) and 90 days post-surgery]
Investigators
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