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

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.

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

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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