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Trial record 90 of 119 for:    ZIRCONIUM

Outcome of Implant-supported Overdentures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03777748
Recruitment Status : Active, not recruiting
First Posted : December 17, 2018
Last Update Posted : December 20, 2018
Institut Straumann AG
Information provided by (Responsible Party):
RWTH Aachen University

Brief Summary:
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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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
Other Names:
  • CM LOC® and CM LOC Flex® (Cendres+Métaux SA, Bienne)
  • (sandblasted/acid-etched) SLActive® Roxolid® implants, Ø 3.3 mm (Straumann, Switzerland)

Primary Outcome Measures :
  1. Investigation of the success rates of the implants [ Time Frame: 5 Years ]
    Implant fracture, implant loss

  2. Marginal bone loss [ Time Frame: 5 years ]
    Measurement of marginal bone loss on standardized radiographs [mm]

Secondary Outcome Measures :
  1. Probing depth [ Time Frame: 5 Years ]
    Measurement of probing depth [mm]

  2. Gingival status [ Time Frame: 5 Years ]
    Assessment of gingival index

  3. Oral hygiene [ Time Frame: 5 Years ]
    Assessment of plaque index

  4. 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.

  5. 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".

  6. 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.

  7. 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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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Female and male subjects older than 18 years.
  • Edentulous patients with a bone atrophy, which necessitates the use of diameter-reduced implants and excessive augmentation procedures are denied by the patient.
  • Sufficient bone supply with minimal risk of injury to neighboring structures when using two 10 mm or longer implants per jaw.
  • Bone height above the N. alveolaris inferior of at least 11 mm and the precondition of a one-stage implantation and augmentation.
  • Good health condition according to the Physical Status Classification System one or two (American Society of Anesthesiologists, ASA 2010)
  • Good oral hygiene and an at most moderate tobacco consumption
  • Signed informed consent

Exclusion Criteria:

  • Indication for large augmentations of the jaw bone
  • Allergy to metallic implant components or prosthesis plastics
  • Bisphosphonate therapy
  • Chemo-, immuno-, or radiation therapy
  • Psychological disorder
  • Substance abuse
  • Pregnant woman
  • Persons who are placed in an institution on a judicial or administrative order
  • Any other circumstances that prevent the use of oral surgery

Richter E, Knapp WJI. Auf zwei Eckzahnimplantaten abgestützte Oberkiefer-Coverdentureprothesen-Ergebnisse einer klinischen Studie. 2010;18:165-174.

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Responsible Party: RWTH Aachen University Identifier: NCT03777748     History of Changes
Other Study ID Numbers: UKA 373147
First Posted: December 17, 2018    Key Record Dates
Last Update Posted: December 20, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by RWTH Aachen University:
Oral Health Impact Factor
Survival rate
Maxillary overdenture
Bone Resorption
Anchor System
Additional relevant MeSH terms:
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Bone Resorption
Alveolar Bone Loss
Mouth, Edentulous
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases
Bone Diseases
Musculoskeletal Diseases
Periodontal Atrophy
Periodontal Diseases