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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational [Patient Registry]

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

Brief 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

    Detailed Summary:

    1.1 Background and significance

    The effectiveness of mandibular overdentures retained by 2 dental implants and its impact on Oral Health-Related Quality of Life (OHRQoL) and patient satisfaction has been extensively documented over the last decades(1-6). According to recent systematic reviews, the implant survival rate of this oral rehabilitation concept reaches more than 95% (7-10). The scientific validation of the efficacy of such a rehabilitation concept has influenced the social security system of several countries like Belgium. Therefore, this treatment approach is nowadays considered as an evidence-based and cost-effective treatment option improving the function and quality of life of mandibular edentulous patients. Unfortunately, cost-effective treatment concept to restore the edentulous maxilla not has been widely documented (11). Many studies display high success rates of fixed implant-supported rehabilitations of the edentulous maxilla (12) but these treatment options remain costly and are therefore reserved to a limited social category of patients.

    This work is important because there is a need to provide affordable and efficient implant treatment approaches to restore function and improve satisfaction and OHRQoL of patients with edentulous maxillae.

    1.2 Preliminary studies in connection with new projects/continuing projects

    Even though some authors have described implant survival rates of implant-retained overdentures in the upper maxilla (8, 13-16), most of the treatment approaches involves bars. The placement of 4 implants and individual attachments is a more cost-effective treatment modality that is poorly documented in the literature in terms of implants and prosthodontics outcomes but also on aspects assessi
    Sponsor: University Hospital of Liege

    Current Primary Outcome: Implant outcomes [ Time Frame: 5 years ]

    At each follow-up visit (3 months, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years), a clinical exam including plaque assessment, bleeding on probing and mucosal palpation will be done. A CBCT scan will be done directly after surgery and at one year post-surgery. Specifically, the integration will be considered successful if the following parameters are met: (1) absence of recurring peri-implant infection with suppuration; (2) absence of persistent subjective complaints such as pain, foreign body sensation, and/or dysesthesia; (3) absence of a continuous radiolucency around the implant; and (4) absence of any detectable implant mobility. Marginal bone levels will be measured using CBCT radiograph at baseline and 1, 3 and 5 years follow-up, using the implant neck as reference point and calibrating them using Image J64. Marginal bone remodeling will be calculated accordingly. CBCT radiographs will be taken using the bisector technique.


    Original Primary Outcome: Same as current

    Current Secondary Outcome: Prosthodontics success rates [ Time Frame: 5 years ]

    At each follow-up visit (3 months, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years), the proper adaptation of the prosthesis, the retention of attachments and the mastication aptitude will be verified. A fracture of the Locator attachments will be considered as a prosthodontics failure and will directly influence the prosthodontics success rates. The possible prosthodontics complications, such as base fracture, attachment loss (unscrewing, or discementation) and loss of retention, will be recorded as prosthodontics complications and managed appropriately.


    Original Secondary Outcome: Same as current

    Information By: University Hospital of Liege

    Dates:
    Date Received: March 6, 2014
    Date Started: June 2014
    Date Completion: November 2020
    Last Updated: April 13, 2017
    Last Verified: April 2017