Outcome of Implant-supported Overdentures
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|ClinicalTrials.gov Identifier: NCT03777748|
Recruitment Status : Active, not recruiting
First Posted : December 17, 2018
Last Update Posted : December 20, 2018
RWTH Aachen University
Institut Straumann AG
Information provided by (Responsible Party):
RWTH Aachen University
The aim of this pilot study was to assess survival rates and peri-implant bone loss of two narrow-diameter titanium-zirconium implants supporting maxillary and mandibular overdentures during an observation time of 3 years. The masticatory performance, self-reported chewing ability and change of oral health impact profile (OHIP) after rehabilitation were also investigated.
|Condition or disease||Intervention/treatment||Phase|
|Alveolar Bone Loss Bone Resorption Dental Implants Edentulous Maxilla Edentulous Patient||Device: dental implants and stud attachments||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study to Clinically Evaluate Maxillary and Mandibular Overdentures Retained by Two Unsplinted Diameter-reduced Titanium-zirconium Implants|
|Actual Study Start Date :||June 1, 2013|
|Actual Primary Completion Date :||April 1, 2016|
|Estimated Study Completion Date :||December 30, 2022|
Experimental: Two dental implants in the edentulous maxilla and mandible
Edentulous maxilla und mandible are treated with two diameter-reduced tissue level implants (Straumann, Basel) and anchored with CM LOC® and CM LOC Flex® attachments (Cendres+Métaux SA, Bienne).
Device: dental implants and stud attachments
Primary Outcome Measures :
- Investigation of the success rates of the implants [ Time Frame: 5 Years ]Implant fracture, implant loss
- Marginal bone loss [ Time Frame: 5 years ]Measurement of marginal bone loss on standardized radiographs [mm]
Secondary Outcome Measures :
- Probing depth [ Time Frame: 5 Years ]Measurement of probing depth [mm]
- Gingival status [ Time Frame: 5 Years ]Assessment of gingival index
- Oral hygiene [ Time Frame: 5 Years ]Assessment of plaque index
- Oral Health Quality of Life [ Time Frame: 5 years ]Oral Health Impact Profile - G14 (OHIP-G14, short version of the OHIP with 14 questions, according to Slade). Responses are made on a scale of never (0), hardly (1), occasionally (2), fairly often (3) and very often (4), resulting in possible values from 0 to 56 points in total.
- Chewing satisfaction [ Time Frame: 5 years ]Assessment of the chewing satisfaction using a Visual Analogue Scale (VAS). The beginning of the scale is defined as "completely dissatisfied" and the end of the line as "completely satisfied".
- Masticatory performance [ Time Frame: 5 years ]Assessment of the masticatory performance with a standardized chewing test. The participants are instructed to chew standardised gums with three degrees of hardness for 30 seconds each on the right and left sides as well as on both sides. The chewed particles were then spread to a standardized detection sheet. Each sheet is placed in a standardized stand support and are photographed.
- Survival rate of prosthetic restoration [ Time Frame: 5 years ]The prosthesis is examined for cracks, fractures, discolorations or other defects. Pass accuracy is examined. Visual and tactile control of the CM LOC® abutments and of the matrices (with retention inserts) are done.
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