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 enrollmentSeptember 23, 2024

ConditionsEdentulous Dental Implant Failure Surgery - Other surgery Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Edentulous
Sponsor: Master in Oral Surgery and Implantology, University of Granada
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>]
Status: Not yet recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

September 23, 2024

End Date

TBD

Last Updated

last year

Study Type

Interventional

Sex

All

Investigators

Sponsor

Master in Oral Surgery and Implantology, University of Granada

Eligibility Criteria

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]