CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 30 enrolled
Drug / intervention
Implants-supported locators placementprocedure
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/NCT02380404
NCT02380404N/ACompleted

Clinical Outcomes of a Cost-effective Implant Treatment in the Edentulous Upper Maxilla: Effectiveness of Removable Prosthesis Retained by 4 Implant-supported Locator-Attachments.

University of Liege·observational·Posted Mar 5, 2015·Updated May 19, 2022

In Brief

An observational study evaluating Implants-supported locators placement for Edentulous Alveolar Ridge. Completed, enrolled 30 participants across 2 sites.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesBelgium

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMar 5, 2015
Enrollment StartApr 2, 2014
Primary CompletionMar 1, 2016
Study CompletionNov 1, 2020
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 11.3 years ago

Interventions

Implants-supported locators placementprocedure

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.