Influence of Implants and Locators for Improved Retention
NCT ID: NCT02551146
Last Updated: 2022-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
14 participants
INTERVENTIONAL
2015-09-07
2018-05-17
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
A Locator with retention elements
Insertion of GC Pilier locator abutments with retention elements
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.
B Locator without retention elements
Insertion of GC Pilier locator abutments without retention elements
Interventions
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A Locator with retention elements
Insertion of GC Pilier locator abutments with retention elements
B Locator without retention elements
Insertion of GC Pilier locator abutments without retention elements
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
45 Years
80 Years
ALL
No
Sponsors
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Philipps University Marburg
OTHER
Responsible Party
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Principal Investigators
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Reiner Mengel, Professor MD
Role: PRINCIPAL_INVESTIGATOR
Dept. of Prosthodontics and Orofacial Function Philipps-University, School of Dental Medicine
Locations
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Dept. of Prosthodontics and Orofacial Function Philipps-University, School of Dental Medicine
Marburg, , Germany
Countries
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References
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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.
Other Identifiers
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KKS-217
Identifier Type: -
Identifier Source: org_study_id