Clinical trial NCT06504888: Do Penicillin-allergic Patients Presents a High Risk of Sinus Lift Failure
Official title: Influence of Penicillin-allergy on Sinus Lift Procedures: a Retrospective Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Maxillary Sinus Disease
Keywords: Penicillin allergy
Dental implant
Sinus lift failure
Lead sponsor: Universitat Internacional de Catalunya
Sponsor class: OTHER
First posted: 2024-07-17
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing lateral sinus lift and rehabilitated with dental implants

Brief summary: This retrospective study aims to evaluate clinical histories to determine if there is a relationship between patients allergic to penicillin and sinus lift failure and the possible post-operative complications that may arise.

Detailed description: Introduction: It is known that patients allergic to penicillin have a tendency to have greater failure of dental implants. It is believed that when prescribing non-penicillin antibiotics, such as clindamycin, the bacterial spectrum is not as wide as penicillin, and it is commonly associated with more drug-resistant microorganisms, such as Cloastridium difficile.

However, this statement, which is well studied in implants, has not been studied as much in sinus lift as a surgical technique.

Objectives

* Primary objectives: For that reason, the primary objective of this study is to evaluate retrospectively, if penicillin allergic patients presents higher risk of failure in lateral sinus lift procedure compared to none-allergic penicillin patients.
* Secondary objectives: Evaluate the differences, in terms of implant failure and intraoperative and post-operative sinus lift complications, between patients allergic to penicillin and those who are not allergic.

Materials and Methods: This retrospective study analyzed patients undergoing lateral sinus lift and rehabilitated with dental implants between the years 2004 and 2024 at the dental clinic of Universitat Internacional de Catalunya, Barcelona (UIC). This study will include adult patients in whom a lateral sinus lift with simultaneous or delayed implants was performed at the university. The clinical history should determine whether or not you are allergic to penicillin, the possible pre- and post-operative complications of the surgical intervention and the evaluation regarding the sinus lift surgery (whether it fails or not) and the subsequent placement of the implant.

Eligibility criteria: Inclusion Criteria: men and women over 18 years of age, patients undergoing at least one sinus lift procedure with simultaneous or deferred placement of implants; and patients' containing the following data: (1) Penicillin allergy: presence or absence; (2) Prescribed antibiotic guidelines; (3) Intraoperative complications: no complications, Schneider membrane's perforation; (4) Postoperative complications: No complications, fistula, infection, unspecific failure, hemorrhage, healing by second intention; (5) Results of sinus lift procedure: failure or not; (6) Results of implant placement: failure or not.

Exclusion Criteria: (1) Medical history that was not fully complied with; (2) Patients who did not attend follow-up visits.

Primary outcomes:
measure: Maxillary sinus lift procedure failure
timeFrame: 2 years
Secondary outcomes:
measure: Implant survival rate
timeFrame: 1 year after implant placement
measure: Post-operative complications
timeFrame: 1-2 weeks after surgery
measure: Intra-operative complications
timeFrame: In the surgery
Other outcomes:
Locations:
city: Sant Cugat Del Vallès
country: Spain
facility: Universitat Internacional de Catalunya
state: Barcelona
Study officials:
References: