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CF41102 5-year Clinical Evaluation of Conelog® Implant With 7 mm Length (UKAConelog)

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.
 
ClinicalTrials.gov Identifier: NCT03558347
Recruitment Status : Unknown
Verified March 2020 by RWTH Aachen University.
Recruitment status was:  Active, not recruiting
First Posted : June 15, 2018
Last Update Posted : March 17, 2020
Sponsor:
Collaborator:
Camlog Foundation
Information provided by (Responsible Party):
RWTH Aachen University

Study Description
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Brief Summary:
The objective of this prospective, randomized, pilot study is to determine whether the Conelog® connection is suitable for splinted/non-splinted cemented crowns in the chewing centre (focus only on implant-abutment connection) and whether implants with the Conelog® connection and a length of 7mm are suitable for use in the molar region of the lower jaw.

Condition or disease Intervention/treatment Phase
Dental Implants Partial Edentulism Device: short implants with splinted crowns Device: short implants with non-splinted crowns Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This study consists of 20 patients (15 female, 5 male, mean age 59) who, after implant placement and second stage surgery, are randomly divided into two groups: group A was treated with two splinted crowns, group B with non-splinted single crowns. Four patients with bilateral free-end situation received both splinted and non-splinted restorations.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 5 Year Clinical Evaluation of CONELOG® Screw-Line Implants With 7 mm Length: a Prospective Randomized Double-blinded Clinical Study
Actual Study Start Date : March 1, 2012
Actual Primary Completion Date : September 27, 2016
Estimated Study Completion Date : September 27, 2021
Arms and Interventions
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Arm Intervention/treatment
Experimental: short implants with splinted crowns
Patients of that group received splinted crowns on the two adjacent implants Intervention: short implants with splinted crowns
 Device: short implants with splinted crowns
7 mm short implants (CONELOG® Implant System), individualized titanium abutments, splinted lithium disilicate crowns
Other Name: CONELOG® Implant System
Experimental: short implants with non-splinted crowns
Patients of that group received single crowns on the two adjacent implants Intervention: short implants with non-splinted crowns
 Device: short implants with non-splinted crowns
7 mm short implants (CONELOG® Implant System), individualized titanium abutments, non-splinted lithium disilicate crowns
Other Name: CONELOG® Implant System


Outcome Measures
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Primary Outcome Measures :
  1. 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. survival rate of prosthetic restoration [ Time Frame: 5 years ]
    screw loosening, screw fracture, implant fracture, chippings


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

Inclusion Criteria:

  • female and male subjects older than 18 years
  • absence of all molars and, optionally, the second premolar in at least on quadrant of the lower jaw
  • the periodontal situation of the other teeth is healthy or periodontal treatment has already been successfully performed
  • the antagonists are natural teeth or treated with fixed dentures
  • good health according to the ASA Physical Status Classification System one or two (ASA 2010)
  • good oral hygiene and an at most moderate tobacco consumption
  • bone height above the N. alveolaris inferior of at least 11mm and the precondition of a one-stage implantation and augmentation
  • signed consent

Exclusion Criteria:

  • Indication for large augmentations of the jaw bone
  • Bone abundance with minimal risk of injury to neighbouring structures when using two 11 mm or longer implants
  • Psychological disorder
  • substance abuse
  • removable dentures (with or without implants)
  • pregnancy
  • patients under age or unable to reason
  • persons who are placed in an institution on a judicial or administrative order
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03558347


Locations
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Germany
Universitätsklinikum Aachen
Aachen, NRW, Germany, 52072
Sponsors and Collaborators
RWTH Aachen University
Camlog Foundation
Investigators
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Study Director: Stefan Wolfart, Prof. Dr. University Hospital, Aachen
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: RWTH Aachen University
ClinicalTrials.gov Identifier: NCT03558347    
Other Study ID Numbers: UKA 360569
First Posted: June 15, 2018    Key Record Dates
Last Update Posted: March 17, 2020
Last Verified: March 2020
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