Clinical Trial: Influence of Implants and Locators for Improved Retention

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Influence of Implants and Locators for Improved Retention of Mandibular Full Dentures on Patient's Quality of Life and Oral Function. A Controlled, Randomized and Prospective Study

Brief Summary: The aim of this study is to assess the influence of this particular treatment method on the patients' quality of life and masticatory function.

Detailed Summary:

For this prospective randomized controlled clinical trial patients with edentulous mandibles and tissue supported (full) dentures were treated with 2 dental implants and locators in order to improve prosthesis stability.

The LOCATOR System is comprised of three parts: The LOCATOR implant attachment (LOCATOR abutment), the LOCATOR Male and the LOCATOR Denture Cap. The abutment is inserted directly into the implant using a torque wrench, while the Denture Cap is placed into the base of the overdenture for polymerization using acrylic resin. Custom retention is achieved via LOCATOR Males - small color-coded (according to retention force) plastic inserts - which can be exchanged as needed.


Sponsor: Philipps University Marburg Medical Center

Current Primary Outcome: Quality of life [ Time Frame: 3 months after randomization ]

The oral health-related quality of life is assessed by the German version of the Oral Health Impact Profile questionnaire (OHIP-G-49, Locker et al 1993)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • masticatory function [ Time Frame: 3 months (T0), 6 months (T1), 9 months (T2), 12 months (T3) ]
    Video documentation of chewing a defined bolus. After chewing a defined bolus for 10 seconds comparison of reduction ratio of the bolus is documented by photography and the change from baseline will be documented.
  • Plaque index [ Time Frame: 3 months (T0), 6 months (T1), 9 months (T2), 12 months (T3) ]
    The Plaque index (Silness and Loe 1964) will be assessed and the change from baseline will be documented.
  • Probing pocket depth [ Time Frame: 3 months (T0), 6 months (T1), 9 months (T2), 12 months (T3) ]
    The Probing pocket depth with bleeding on probing (6 sites of every tooth and implant) will be assessed and the change from baseline will be documented.
  • Gingival index [ Time Frame: 3 months (T0), 6 months (T1), 9 months (T2), 12 months (T3) ]
    The Gingival index (Loe and Silness 1963) will be assessed and the change from baseline will be documented.
  • Gingival recessions [ Time Frame: 3 months (T0), 6 months (T1), 9 months (T2), 12 months (T3) ]
    The Gingival recessions at teeth will be assessed and the change from baseline will be documented.
  • Mucosal recessions [ Time Frame: 3 months (T0), 6 months (T1), 9 months (T2), 12 months (T3) ]
    The mucosal recessions at implants will be assessed and the change from baseline will be documented.
  • width of keratinized gingiva/mucosa [ Time Frame: 3 months (T0), 6 months (T1), 9 months (T2), 12 months (T3) ]
    The width of keratinized gingiva/mucosa will be assessed and the change from baseline will be documented.
  • intraoral photo-documentation [ Time Frame: 3 months (T0), 6 months (T1), 9 months (T2), 12 months (T3) ]
    A photo-documentation (intraoral) will be done to assess the changes from baseline.


Original Secondary Outcome: Same as current

Information By: Philipps University Marburg Medical Center

Dates:
Date Received: September 3, 2015
Date Started: September 2015
Date Completion: September 2017
Last Updated: April 3, 2017
Last Verified: July 2016