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

NCT ID: NCT06504888

Last Updated: 2024-07-17

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2004-07-01
• Study Completion Date: 2024-12-31

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.

Conditions

Maxillary Sinus Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Patients allergic to penicillin

Patients who cannot take any type of penicillin, who have undergone a lateral sinus lift with simultaneous or delayed dental implant.

No interventions assigned to this group

Patients who are not allergic to penicillin

Patients who can take some type of penicillin, who have had a lateral sinus lift with simultaneous or delayed dental implant.

Penicillin

Intervention Type: DRUG

Compare whether there is a higher incidence of sinus elevation in patients allergic to penicillin compared to non-allergic patients, evaluating clinical histories.

Interventions

Penicillin

Compare whether there is a higher incidence of sinus elevation in patients allergic to penicillin compared to non-allergic patients, evaluating clinical histories.

Intervention Type: DRUG

Other Intervention Names

Sinus lift procedure

Eligibility Criteria

Inclusion 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universitat Internacional de Catalunya

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Universitat Internacional de Catalunya

Sant Cugat del Vallès, Barcelona, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Andrea Galve

Role: CONTACT

andreagalve@UIC.es

659051488

Facility Contacts

Andrea Galve

Role: primary

andreagalve@UIC.es

+34659051487

Javier Gamon

Role: backup

jgamon@uic.es

+34627321249

Other Identifiers

CIR-ELC-2021-06

Identifier Type: -

Identifier Source: org_study_id