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Mandibular Overdentures Retained by Mini Implants: a Clinical Trial Comparing Different Surgical and Loading Protocols

NCT04760457 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2023-05-10

No results posted yet for this study

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.

Conditions

  • Edentulous Mouth
  • Complete Edentulism

Interventions

PROCEDURE

Implant placement with flapped surgery

Four mini implants will be placed reflecting a flap.

PROCEDURE

Implant placement with flapless surgery

Four mini implants will be placed without reflecting a flap.

PROCEDURE

Implant immediate loading

Four mini implants will be immediately loaded.

PROCEDURE

Implant delayed loading

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

Sponsors & Collaborators

  • ITI International Team for Implantology, Switzerland

    collaborator OTHER

  • Institut Straumann AG

    collaborator INDUSTRY

  • Universidade Federal de Goias

    lead OTHER

Principal Investigators

  • Claudio R Leles, DDS, PhD · Universidade Federal de Goias

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
FACTORIAL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-01
Primary Completion
2022-11-30
Completion
2022-11-30

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04760457 on ClinicalTrials.gov