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Partially-guided Protocol for Maxillary Overdentures Retained by Ti-Zr One-piece Mini Implants

NCT06081192 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2023-10-13

No results posted yet for this study

Summary

This is a single-center, single-group, prospective clinical trial testing a partially-guided protocol for placement of mini implants overdentures in the edentulous maxilla. Eligible participants will be subjects with an edentulous maxilla, wearing a conventional complete denture. Participants will receive six mini implants (Straumann® Mini Implant System, Institut Straumann AG, Switzerland) for retention of a maxillary overdenture. The six mini implant protocol will be virtually planned for an even distribution of the implants bilaterally, with a minimum of 5 mm distance between contiguous implants. The available lengths of the mini implants are 10, 12, and 14 mm, and the appropriate length will be selected according to the bony anatomical situation. In addition, the distribution and axial position of the mini implants will be planned to achieve the best biomechanical distribution and the most parallel position between implants, perpendicular to the occlusal plane and path of insertion of the prosthesis. The primary outcome will be the accuracy of the implant position using the partially-guided protocol. Assessment of the accuracy of the methods will be based on the measure of the difference between the actual and the planned position of the mini implants, based on the measurement of (1) the global deviations at the coronal and apical regions of the mini implants, (2) the vertical deviation, and (3) the apical angle deviation. Overall impacts of treatment on oral health-related quality of life will be assessed using the Oral Health Impact Profile instrument for edentulous subjects (OHIP-EDENT). Additional outcomes will include implant survival and success rates, incidence of prosthodontic complications and peri-implant measurements.

Conditions

  • Edentulous Jaw
  • Implant Complication

Interventions

PROCEDURE

Implant placement surgery

Placement of six mini implants in the edentulous maxilla using a partially-guided protocol

Sponsors & Collaborators

  • ITI International Team for Implantology, Switzerland

    collaborator OTHER

  • Institut Straumann AG

    collaborator INDUSTRY

  • Universidade Federal de Goias

    lead OTHER

Principal Investigators

  • Cláudio R Leles, PhD · Universidade Federal de Goias

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-31
Primary Completion
2025-08-31
Completion
2025-12-31

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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 NCT06081192 on ClinicalTrials.gov