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

Influence of Penicillin-allergy on Sinus Lift Procedures: a Retrospective Study

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.

Study Overview

• Status: Recruiting
• Conditions: Maxillary Sinus Disease
• Intervention / Treatment: Drug: Penicillin

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.

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

• Study Contact: Name: Andrea Galve; Phone Number: 659051488; Email: andreagalve@UIC.es

Study Locations

• Spain
  • Barcelona
    • Sant Cugat Del Vallès, Barcelona, Spain, 08195
      • Recruiting
      • Universitat Internacional de Catalunya
      • Contact: Andrea Galve; Phone Number: +34659051487; Email: andreagalve@UIC.es
      • Contact: Javier Gamon; Phone Number: +34627321249; Email: jgamon@uic.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing lateral sinus lift and rehabilitated with dental implants

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.
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.	Drug: Penicillin; Compare whether there is a higher incidence of sinus elevation in patients allergic to penicillin compared to non-allergic patients, evaluating clinical histories.; Other Names: Sinus lift procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maxillary sinus lift procedure failure	"Inability to place the implant after sinus lift"	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant survival rate	"The implant is still in mouth"	1 year after implant placement
Post-operative complications	Fistula, infection, unspecific failure, hemorrhage or healing by second intention	1-2 weeks after surgery
Intra-operative complications	Schneider membrane's perforation: 1-2mm, 2-5mm, 5-10mm or >10mm	In the surgery

Collaborators and Investigators

• Sponsor: Universitat Internacional de Catalunya

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2004
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: July 10, 2024
• First Submitted That Met QC Criteria: July 16, 2024
• First Posted (Actual): July 17, 2024

Study Record Updates

• Last Update Posted (Actual): July 17, 2024
• Last Update Submitted That Met QC Criteria: July 16, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Dental implant; Penicillin allergy; Sinus lift failure
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Nose Diseases; Paranasal Sinus Diseases; Anti-Infective Agents; Anti-Bacterial Agents; Penicillins
• Other Study ID Numbers: CIR-ELC-2021-06

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No