CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 74 enrolled
Drug / intervention
Implant placement with flapped surgery +3 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04760457
NCT04760457N/ACompleted
CompareCT.gov

One-piece TiZr Mini Implants With Miniaturized Carbon-based Coating Prosthetic Connection for Mandibular Overdentures: a Factorial, Randomized Clinical Trial Testing the Outcomes of Immediate/Delayed Loading and Flapped/Flapless Surgery

Universidade Federal de Goias·interventional·Posted Feb 18, 2021·Updated May 10, 2023

In Brief

A clinical study evaluating Implant placement with flapped surgery, Implant placement with flapless surgery, and 2 other interventions for Edentulous Mouth and Complete Edentulism. Completed, enrolled 74 participants across 1 site.

Detailed Summary

This study aims to test the combined effects of different loading protocols and surgical approaches on clinical and patient-reported outcome measures (PROMs) following the use of four mini implants for mandibular overdenture retention. The main study hypotheses are: 1. There are significant improvements in PROMs following implant intervention compared to baseline measures; 2. Immediately loaded mini implants have similar failure rates compared to mini implants receiving a delayed 6-week protocol. 3. Flapless surgery has similar post-insertion outcomes compared to flapped surgery.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEdentulous Mouth, Complete Edentulism
CountriesBrazil
CollaboratorsITI International Team for Implantology, Switzerland, Institut Straumann AG

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedFeb 18, 2021
Enrollment StartMar 1, 2021
Primary CompletionNov 30, 2022
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 5.4 years ago

Interventions

Implant placement with flapped surgeryprocedure

Four mini implants will be placed reflecting a flap.

Implant placement with flapless surgeryprocedure

Four mini implants will be placed without reflecting a flap.

Implant immediate loadingprocedure

Four mini implants will be immediately loaded.

Implant delayed loadingprocedure

Four mini implants will be loaded after a 6-week healing period.