- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06759246
Short Implants in Atrophic Posterior Maxilla
January 4, 2025 updated by: Giuseppe D'Albis, University of Bari Aldo Moro
Short Implant Placement for Single-Tooth Rehabilitation in the Atrophic Posterior Maxilla
This study aims to evaluate the clinical and radiological outcomes of short implants in the rehabilitation of single-tooth edentulism in the posterior maxilla.
By assessing these outcomes, the research seeks to determine the effectiveness and long-term viability of short implants as a minimally invasive solution, particularly in cases where bone height is limited.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The present municentric retrospective study was conducted following the STROBE statement recommendations for observational studies and in compliance to the principles of the Declaration of Helsinki on clinical research involving human subjects.The study aims to evaluate short implants placed over the past 15 years by three experienced clinicians, assessing their survival and clinical success.
Specifically, the study collects clinical data such as probing depth, the presence or absence of peri-implantitis, and radiological findings.
Study Type
Interventional
Enrollment (Actual)
150
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Bari, Italy, 70021
- University of Bari Aldo Moro
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Good health status according to the classification system of the American Society of Anesthesiology (ASA), and patients were required to be 18 years of age or older.
- No general medical condition that would contraindicate implant therapy.
- No active periodontal disease, defined as a periodontal probing depth of less than 4 mm, or previously treated periodontitis.
- Good oral hygiene, with a full-mouth plaque index of less than 25%.
- Adequate control of inflammation, with a full-mouth bleeding on probing (BOP) of less than 25%.
Exclusion Criteria:
- Smoking more than 15 cigarettes per day
- Presence of untreated periodontal disease
- Pregnancy or breastfeeding at the time of enrollment
- Active infections
- Less than 2 mm of keratinized mucosal tissue.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Atrophic maxillae
A group of patients with atrophic maxillae requiring rehabilitation for single-tooth edentulism.
|
Placement of short implants for the rehabilitation of single-tooth edentulism in atrophic maxillae near the maxillary sinus.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinical outcome
Time Frame: 2 years
|
Survival rate: A statistical analysis will be conducted to evaluate the implant survival rate at three specific time points: T1 (3 months), T2 (6 months), and T3 (2 years).
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rx outcome
Time Frame: 2 years
|
Radiographic measurements will be obtained using standardized imaging techniques.
The measurements will be performed digitally using dedicated three-dimensional radiological imaging software, ensuring high precision.
Distances will be measured in millimeters to evaluate implant positioning, bone levels, and defect morphology with accuracy.
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Professor Saverio Capodiferro, University of Bari Aldo Moro
- Study Director: Professor Massimo Corsalini, University of Bari Aldo Moro
- Principal Investigator: Dr. D'Albis Giuseppe, University of Bari Aldo Moro
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2014
Primary Completion (Actual)
September 1, 2024
Study Completion (Actual)
November 1, 2024
Study Registration Dates
First Submitted
November 15, 2024
First Submitted That Met QC Criteria
December 28, 2024
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
January 4, 2025
Last Verified
January 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Implants01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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