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Effectiveness of Removable Prosthesis Retained by 4 Implant-supported Locator-Attachments

NCT02380404 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2022-05-19

No results posted yet for this study

Summary

1\. Hypothesis/Specific aims

The aim of the present study proposal is to validate an implant treatment concept in the edentulous upper maxilla using four implants-supported locators abutments to retain removable prosthesis.

Specific aims:

* The primary objective of the study is to evaluate the implant and prosthodontics success rates of the proposed implant treatment approach after a follow-up period of 1, 3 and 5 years as well as the biological and prosthodontics complications.
* The secondary objective is to assess the evolution of patient centered outcomes with the suggested treatment in the maxilla. Oral health-related quality of life (OHRQoL) and patients' satisfaction relating to their prostheses will be considered.
* The third objective will be to compare the implant, prosthodontics and patient-centered outcomes according to the implant distribution; 4 anterior to maxillary sinus (ANT) versus 2 anterior implants and 2 implants in the maxillary tuberosity (POST).

Hypothesis:

* Implant survival rate using this treatment concept is similar to restoration with implant-supported fixed prosthesis, based on published data. No difference of implant survival rates is found between ANT and POST implant distribution.
* Prosthodontics survival rate using the following treatment concept is similar to the ones found with a bar, based on published data. The ANT implant distribution causes fewer prosthodontics complications compared to the POST implant distribution.
* There is a significant improvement in OHRQoL and patient satisfaction compared to the baseline OHRQoL observed with a conventional removable denture. The levels of improvement OHRQoL and patient satisfaction are similar for ANT and POST implant distributions.

Conditions

  • Edentulous Alveolar Ridge

Interventions

PROCEDURE

Implants-supported locators placement

Antibiotics will be prescribed 1 day before surgery and continued for 5 days. Three calibrated surgeons will place 4 NN or RN Roxolid tissue level implants. Two implants have to be placed in the ANT region (lateral or canine) and 2 implants in the POST region (as distal as possible). Angulated implant and placement of implant in the tuberosity region can be considered.

Sponsors & Collaborators

  • Université de Liège

    collaborator OTHER

  • ITI International Team for Implantology, Switzerland

    collaborator OTHER

  • Institut Straumann AG

    collaborator INDUSTRY

  • University of Liege

    lead OTHER

Principal Investigators

  • France Lambert · CHU of Liège

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-04-02
Primary Completion
2016-03-31
Completion
2020-11-30

Countries

  • Belgium

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 NCT02380404 on ClinicalTrials.gov