An interventional study of A Locator with retention elements and B Locator without retention elements in Mouth, Edentulous, sponsored by Philipps University Marburg. Terminated at 1 site in Germany. Open to participants aged 45 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-12-22.
Sponsored by Philipps University Marburg · Not applicable, Interventional, and Treatment
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.
244 studies on the registry are indexed under Mouth, Edentulous; 37 are open to participants now.
This study's enrollment of 14 is below the median of 30 across 187 interventional studies indexed under Mouth, Edentulous.
Browse Mouth, Edentulous studies →Philipps University Marburg is the lead sponsor of 114 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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 with retention elements
Insertion of GC Pilier locator abutments without retention elements
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
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.
Time frame: 3 months (T0), 6 months (T1), 9 months (T2), 12 months (T3)
Plaque index
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)
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.
Time frame: 3 months (T0), 6 months (T1), 9 months (T2), 12 months (T3)
Gingival index
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)
Gingival recessions
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)
Mucosal recessions
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)
width of keratinized gingiva/mucosa
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)
intraoral photo-documentation
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)
Plan to share: No
This study is terminated, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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Philipps University Marburg