Maxillary Sinus DiseaseNCT06504888
Do Penicillin-allergic Patients Presents a High Risk of Sinus Lift Failure
An observational study of Maxillary Sinus Disease, run by Universitat Internacional de Catalunya at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Maxillary Sinus Disease
- What is being tested?
- Penicillin
- How many people
- 400 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jul 2004to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients undergoing lateral sinus lift and rehabilitated with dental implants
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 locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Universitat Internacional de Catalunya
Sant Cugat del Vallès, Barcelona, 08195
Andrea Galve, +34659051487, andreagalve@UIC.es
Javier Gamon, +34627321249, jgamon@uic.es
About this study
Official title: 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.
Read the 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
- Being tested
- Penicillin
- Keywords
- Penicillin allergy, Dental implant, Sinus lift failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PenicillinDrug
Also called Sinus lift procedure
Compare whether there is a higher incidence of sinus elevation in patients allergic to penicillin compared to non-allergic patients, evaluating clinical histories.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Penicillin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maxillary sinus lift procedure failure
"Inability to place the implant after sinus lift"
Measured: 2 years
Secondary outcomes (3)
Implant survival rate
"The implant is still in mouth"
Measured: 1 year after implant placement
Post-operative complications
Fistula, infection, unspecific failure, hemorrhage or healing by second intention
Measured: 1-2 weeks after surgery
Intra-operative complications
Schneider membrane's perforation: 1-2mm, 2-5mm, 5-10mm or >10mm
Measured: In the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study start1 Jul 2004
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maxillary Sinus DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitat Internacional de Catalunya
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06504888
- Sponsor's protocol ID
- CIR-ELC-2021-06
- Status last verified
- Jul 2024
- First submitted
- 10 Jul 2024
- Last updated
- 17 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Penicillin-allergy on Sinus Lift Procedures: a Retrospective Study
- ClinicalTrials.gov ID
- NCT06504888
- Acronym / sponsor ID
- CIR-ELC-2021-06
- Conditions
- Maxillary Sinus Disease
- Keywords
- Penicillin allergy, Dental implant, Sinus lift failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Universitat Internacional de CatalunyaUniversity, hospital or other
- Study start
- 1 Jul 2004 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 17 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Drug: PenicillinPatients who can take some type of penicillin, who have had a lateral sinus lift with simultaneous or delayed dental implant. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing lateral sinus lift and rehabilitated with dental implants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PenicillinAlso: Sinus lift procedureCompare whether there is a higher incidence of sinus elevation in patients allergic to penicillin compared to non-allergic patients, evaluating clinical histories. | Drug | Patients who are not allergic to penicillin |
Primary outcome
Maxillary sinus lift procedure failure
Time frame: 2 years
"Inability to place the implant after sinus lift"
3 secondary outcomes
Implant survival rate
Time frame: 1 year after implant placement
Post-operative complications
Time frame: 1-2 weeks after surgery
Intra-operative complications
Time frame: In the surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Maxillary Sinus Disease, run by Universitat Internacional de Catalunya at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrea Galve (659051488, andreagalve@UIC.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maxillary sinus lift procedure failure (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2024.