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Influence of Implants and Locators for Improved Retention (GC)

Primary Purpose

Mouth, Edentulous

Status
Terminated
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
A Locator with retention elements
B Locator without retention elements
Sponsored by
Philipps University Marburg Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mouth, Edentulous

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

A Locator with retention elements

B Locator without retention elements

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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.
Plaque index
The Plaque index (Silness and Loe 1964) will be assessed and the change from baseline will be documented.
Probing pocket depth
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
The Gingival index (Loe and Silness 1963) will be assessed and the change from baseline will be documented.
Gingival recessions
The Gingival recessions at teeth will be assessed and the change from baseline will be documented.
Mucosal recessions
The mucosal recessions at implants will be assessed and the change from baseline will be documented.
width of keratinized gingiva/mucosa
The width of keratinized gingiva/mucosa will be assessed and the change from baseline will be documented.
intraoral photo-documentation
A photo-documentation (intraoral) will be done to assess the changes from baseline.

Full Information

First Posted
September 3, 2015
Last Updated
December 20, 2022
Sponsor
Philipps University Marburg Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02551146
Brief Title
Influence of Implants and Locators for Improved Retention
Acronym
GC
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Terminated
Why Stopped
Difficulties concerning the recruitment of participants
Study Start Date
September 7, 2015 (Actual)
Primary Completion Date
May 17, 2018 (Actual)
Study Completion Date
May 17, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Philipps University Marburg Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mouth, Edentulous

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A Locator with retention elements
Arm Type
Experimental
Arm Description
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.
Arm Title
B Locator without retention elements
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
A Locator with retention elements
Intervention Description
Insertion of GC Pilier locator abutments with retention elements
Intervention Type
Device
Intervention Name(s)
B Locator without retention elements
Intervention Description
Insertion of GC Pilier locator abutments without retention elements
Primary Outcome Measure Information:
Title
Quality of life (OHIP-G-49)
Description
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 Outcome Measure Information:
Title
masticatory function
Description
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.
Time Frame
3 months (T0), 6 months (T1), 9 months (T2), 12 months (T3)
Title
Plaque index
Description
The Plaque index (Silness and Loe 1964) will be assessed and the change from baseline will be documented.
Time Frame
3 months (T0), 6 months (T1), 9 months (T2), 12 months (T3)
Title
Probing pocket depth
Description
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.
Time Frame
3 months (T0), 6 months (T1), 9 months (T2), 12 months (T3)
Title
Gingival index
Description
The Gingival index (Loe and Silness 1963) will be assessed and the change from baseline will be documented.
Time Frame
3 months (T0), 6 months (T1), 9 months (T2), 12 months (T3)
Title
Gingival recessions
Description
The Gingival recessions at teeth will be assessed and the change from baseline will be documented.
Time Frame
3 months (T0), 6 months (T1), 9 months (T2), 12 months (T3)
Title
Mucosal recessions
Description
The mucosal recessions at implants will be assessed and the change from baseline will be documented.
Time Frame
3 months (T0), 6 months (T1), 9 months (T2), 12 months (T3)
Title
width of keratinized gingiva/mucosa
Description
The width of keratinized gingiva/mucosa will be assessed and the change from baseline will be documented.
Time Frame
3 months (T0), 6 months (T1), 9 months (T2), 12 months (T3)
Title
intraoral photo-documentation
Description
A photo-documentation (intraoral) will be done to assess the changes from baseline.
Time Frame
3 months (T0), 6 months (T1), 9 months (T2), 12 months (T3)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reiner Mengel, Professor MD
Organizational Affiliation
Dept. of Prosthodontics and Orofacial Function Philipps-University, School of Dental Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. of Prosthodontics and Orofacial Function Philipps-University, School of Dental Medicine
City
Marburg
ZIP/Postal Code
35033
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19467020
Citation
Assuncao WG, Barao VA, Delben JA, Gomes EA, Tabata LF. A comparison of patient satisfaction between treatment with conventional complete dentures and overdentures in the elderly: a literature review. Gerodontology. 2010 Jun;27(2):154-62. doi: 10.1111/j.1741-2358.2009.00299.x. Epub 2009 May 6.
Results Reference
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Influence of Implants and Locators for Improved Retention

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