NCT06759246

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
10.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

November 15, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 6, 2025

Completed
Last Updated

January 7, 2025

Status Verified

January 1, 2025

Enrollment Period

10.7 years

First QC Date

November 15, 2024

Last Update Submit

January 4, 2025

Conditions

Keywords

short implantsbone atrophysinus pneumatizationminimal invasive

Outcome Measures

Primary Outcomes (1)

  • Clinical outcome

    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 Outcomes (1)

  • Rx outcome

    2 years

Study Arms (1)

Atrophic maxillae

OTHER

A group of patients with atrophic maxillae requiring rehabilitation for single-tooth edentulism.

Procedure: implant placement

Interventions

Placement of short implants for the rehabilitation of single-tooth edentulism in atrophic maxillae near the maxillary sinus.

Atrophic maxillae

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Bari Aldo Moro

Bari, Bari, 70021, Italy

Location

Related Publications (1)

  • Corsalini M, D'Agostino S, Favia G, Dolci M, Tempesta A, Di Venere D, Limongelli L, Capodiferro S. A Minimally Invasive Technique for Short Spiral Implant Insertion with Contextual Crestal Sinus Lifting in the Atrophic Maxilla: A Preliminary Report. Healthcare (Basel). 2020 Dec 24;9(1):11. doi: 10.3390/healthcare9010011.

    PMID: 33374157BACKGROUND

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone ResorptionBone DiseasesMusculoskeletal DiseasesPeriodontal AtrophyPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Professor Saverio Capodiferro

    University of Bari Aldo Moro

    STUDY DIRECTOR
  • Professor Massimo Corsalini

    University of Bari Aldo Moro

    STUDY DIRECTOR
  • Dr. D'Albis Giuseppe

    University of Bari Aldo Moro

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. D'Albis Giuseppe

Study Record Dates

First Submitted

November 15, 2024

First Posted

January 6, 2025

Study Start

January 1, 2014

Primary Completion

September 1, 2024

Study Completion

November 1, 2024

Last Updated

January 7, 2025

Record last verified: 2025-01

Locations