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Do Penicillin-allergic Patients Presents a High Risk of Sinus Lift Failure

U

Universitat Internacional de Catalunya

Status

Enrolling

Conditions

Maxillary Sinus Disease

Treatments

Drug: Penicillin

Study type

Observational

Funder types

Other

Identifiers

NCT06504888
CIR-ELC-2021-06

Details and patient eligibility

About

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.

Full 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.

Enrollment

400 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

400 participants in 2 patient groups

Patients allergic to penicillin
Description:
Patients who cannot take any type of penicillin, who have undergone a lateral sinus lift with simultaneous or delayed dental implant.
Patients who are not allergic to penicillin
Description:
Patients who can take some type of penicillin, who have had a lateral sinus lift with simultaneous or delayed dental implant.
Treatment:
Drug: Penicillin

Trial contacts and locations

1

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Central trial contact

Andrea Galve

Data sourced from clinicaltrials.gov

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