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

March 15, 2020 updated by: RWTH Aachen University

5 Year Clinical Evaluation of CONELOG® Screw-Line Implants With 7 mm Length: a Prospective Randomized Double-blinded Clinical Study

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

In order to avoid sinus augmentation in the upper jaw and a vertical augmentation in the lower jaw, various manufacturers offer short implants of 6-8mm length. The prevention of augmentative measures, especially in the mandible, is a fundamental component of the minimization of invasiveness while at the same time improving the functional capability. The benefit lies in the possibility to place implants without prior bone augmentation even in difficult anatomical conditions. This significantly reduces the invasiveness which on the one hand allows a higher number of patients to be treated with implants (especially morbid patients and anxiety patients) and on the other hand makes the treatment more predictable, with less risk, cost-efficient and considerably faster. Moreover, new scientific insights are gained in the area of short implants.

As with all implants, the risks associated with the study consist of intraoperative complications (e.g. damage of adjacent structures), failure of the implant (e.g. impairment of wound healing, fracture of the implant body), the abutment or abutment screw (e.g. loosening, fracture), or the crown on the abutment (veneer fracture, scaffold fracture).

The objective is to determine whether implants with the Conelog® connection and a length of 7mm are suitable for splinted/non-splinted monolithic lithium disilicate crowns cemented on individualized titanium abutments in the chewing centre of the mandible. The main indication for short implants is severe atrophy of the jaw, which creates a longer distance from the implant shoulder to the occlusal plane. An unfavourable crown-to-implant ratio means higher stress on the screws, the implant-abutment surface and possibly on the osseointegration of the implants. This raises the question whether splinted crowns have a positive effect on implant survival compared to non-splinted crowns.

The two 7mm Conelog ® implants are either used in the area of the second premolar and the first molar or the first and second molars of the mandible. The diameter of the implant depends on the width of the alveolar bone and ranges from 3.8 to 4.3 mm.

In case of a bilateral free-end situation, both quadrants are treated as part of the study, and both treatment variants are applied by using splinted crowns on one side and individual crowns on the other (split mouth design).

20 patients will be included in the study, which will be divided into two equally sized groups of 10 patients. All patients are recruited by the three clinical investigators at the Department of Prosthodontics and Biomaterials, Centre for Implantology, Medical Faculty, Rheinisch-Westfälische Technische Hochschule Aachen (RWTH) Aachen University Hospital. In order to achieve sufficient patient numbers, the population of Aachen will be informed via print media.

Each patient receives a single dose of antibiotics one hour prior to implant surgery. A mucoperiosteal flap was mobilized and the implants were placed as recommended by the manufacturer, using a surgical template as a guide. Healing abutments were screwed, and submerged healing is used for all implants. Second stage surgery is performed after 3 months. The prosthetic restoration is completed within 4 weeks after exposure.

Patients in group A will receive splinted monolithic lithium disilicate crowns cemented on individualized titanium abutments. Patients in group B will receive 2 non-splinted monolithic lithium disilicate-crowns cemented on individualized titanium abutments.

The cementation is done with Multilink Implant ® on the machined abutments, which have been cleaned for 5 minutes in an ultrasonic cleaner with 95% alcohol. The crowns are conditioned with hydrofluoric acid for 20 seconds and silanized with Monobond Plus® for 60 seconds. The day of insertion of the restoration is marked as baseline.

The examination performed at baseline and the follow up after 6 months includes occlusion, probing depth, plaque index and the condition of the ceramic surface of the crowns. Additionally, radiographs with customized positioning jigs are taken at baseline, after 1, 3, and 5 years.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • NRW
      • Aachen, NRW, Germany, 52072
        • Universitätsklinikum Aachen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • CONELOG® Implant System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
marginal bone loss
Time Frame: 5 years
measurement of marginal bone loss on standardized radiographs [mm]
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
probing depth
Time Frame: 5 years
measurement of probing depth [mm]
5 years
gingival status
Time Frame: 5 years
assessment of gingival index
5 years
oral hygiene
Time Frame: 5 years
assessment of plaque index
5 years
survival rate of prosthetic restoration
Time Frame: 5 years
screw loosening, screw fracture, implant fracture, chippings
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RWTH Aachen University

Collaborators

Camlog Foundation

Investigators

  • Study Director: Stefan Wolfart, Prof. Dr., University Hospital, Aachen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2012

Primary Completion (Actual)

September 27, 2016

Study Completion (Anticipated)

September 27, 2021

Study Registration Dates

First Submitted

May 4, 2018

First Submitted That Met QC Criteria

June 4, 2018

First Posted (Actual)

June 15, 2018

Study Record Updates

Last Update Posted (Actual)

March 17, 2020

Last Update Submitted That Met QC Criteria

March 15, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • UKA 360569

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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