Influence of Implants and Locators for Improved Retention

Philipps University Marburg14 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Mouth, Edentulous

Interventions

A Locator with retention elementsDEVICE

Insertion of GC Pilier locator abutments with retention elements

B Locator without retention elementsDEVICE

Insertion of GC Pilier locator abutments without retention elements

Eligibility

Sex: ALLMin age: 45 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * age 45-80 years (male or female) * sufficient full dentures in the mandible * must be able to clean their teeth on their own * edentulous mandible with interforaminal adequate bone for insertion of implants * implantation sites free of infections and root fragments * no need for treatment of the maxillary teeth * Written Informed Consent Exclusion Criteria: * systemic diseases * mental disability that may affect the participant's ability to properly follow study instructions * oral mucosal diseases * long-term medication with steroids, bisphosphonates * known allergic reactions to dental materials * malignant tumor in the head and neck area * requirement of any concurrent radiotherapy or chemotherapy or any radiotherapy or chemotherapy within the last 10 years pregnancy or breastfeeding at study entry

Locations (1)

Dept. of Prosthodontics and Orofacial Function Philipps-University, School of Dental Medicine

Marburg, Germany

Outcomes

Primary Outcomes

Quality of life (OHIP-G-49)

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)

Time frame: 3 months after randomization

Secondary Outcomes

masticatory function

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.