Influence of Implants and Locators for Improved Retention (GC)

December 20, 2022 updated by: Philipps University Marburg Medical Center

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Marburg, Germany, 35033
        • Dept. of Prosthodontics and Orofacial Function Philipps-University, School of Dental Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

41 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A Locator with retention elements

GC Pilier Locator abutment with retention elements:

For patients in the experimental group (arm A) the connection of the full dentures to the implants will be achieved by fitting the dentures with GC Pilier Locator abutments with retention elements.
Device: A Locator with retention elements
Insertion of GC Pilier locator abutments with retention elements
Active Comparator: B Locator without retention elements

GC Pilier Locator abutment without retention elements:

For patients with the active comparator (arm B) the full dentures will get Pilier Locator abutments without retention elements and thus no connection to the implants.
Device: B Locator without retention elements
Insertion of GC Pilier locator abutments without retention elements

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life (OHIP-G-49)
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)
3 months after randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months (T0), 6 months (T1), 9 months (T2), 12 months (T3)
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.
3 months (T0), 6 months (T1), 9 months (T2), 12 months (T3)
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.
3 months (T0), 6 months (T1), 9 months (T2), 12 months (T3)
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.
3 months (T0), 6 months (T1), 9 months (T2), 12 months (T3)
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.
3 months (T0), 6 months (T1), 9 months (T2), 12 months (T3)
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.
3 months (T0), 6 months (T1), 9 months (T2), 12 months (T3)
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.
3 months (T0), 6 months (T1), 9 months (T2), 12 months (T3)
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.
3 months (T0), 6 months (T1), 9 months (T2), 12 months (T3)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Philipps University Marburg Medical Center

Investigators

  • Principal Investigator: Reiner Mengel, Professor MD, Dept. of Prosthodontics and Orofacial Function Philipps-University, School of Dental Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 7, 2015

Primary Completion (Actual)

May 17, 2018

Study Completion (Actual)

May 17, 2018

Study Registration Dates

First Submitted

September 3, 2015

First Submitted That Met QC Criteria

September 15, 2015

First Posted (Estimate)

September 16, 2015

Study Record Updates

Last Update Posted (Estimate)

December 22, 2022

Last Update Submitted That Met QC Criteria

December 20, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KKS-217

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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