NCT06504888

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2004

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
20 years until next milestone

First Submitted

Initial submission to the registry

July 10, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 17, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

July 17, 2024

Status Verified

July 1, 2024

Enrollment Period

20.5 years

First QC Date

July 10, 2024

Last Update Submit

July 16, 2024

Conditions

Maxillary Sinus Disease

Keywords

Penicillin allergyDental implantSinus lift failure

Outcome Measures

Primary Outcomes (1)

  • Maxillary sinus lift procedure failure

    "Inability to place the implant after sinus lift"

    2 years

Secondary Outcomes (3)

  • Implant survival rate

    1 year after implant placement

  • Post-operative complications

    1-2 weeks after surgery

  • Intra-operative complications

    In the surgery

Study Arms (2)

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

Interventions

PenicillinDRUG

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

Also known as: Sinus lift procedure
Patients who are not allergic to penicillin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing lateral sinus lift and rehabilitated with dental implants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitat Internacional de Catalunya

Sant Cugat del Vallès, Barcelona, 08195, Spain

RECRUITING

MeSH Terms

Interventions

Penicillins

Intervention Hierarchy (Ancestors)

beta-LactamsLactamsAmidesOrganic ChemicalsSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Central Study Contacts

Andrea Galve

CONTACT

659051488andreagalve@UIC.es

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2024

First Posted

July 17, 2024

Study Start

July 1, 2004

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

July 17, 2024

Record last verified: 2024-07

Locations

ES(1)