Two Implants Versus One Implant With a Cantilever - a Randomized Controlled Clinical Trial

May 12, 2023 updated by: University of Zurich
The aim of the present study is to test whether there is a difference in the marginal bone level change between implants with and without cantilevers.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

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

  • Switzerland
      • Zurich, Switzerland, 8032
        • Center of Dental Medicine Clinic of Reconstructive Dentistry

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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • male and female patients 18 years to 80 years of age
  • no general medical condition which represents a contraindication to implant treatment
  • two adjacent missing teeth in the maxilla or mandible in positions of premolars and molars
  • at least one tooth present adjacent to the edentulous space
  • indication for implant treatment is given
  • at least 8 mm of vertical bone height in the mandible allowing for the placement of a 6 mm implant (2 mm safety distance to inferior alveolar nerve)
  • at least 4 mm of vertical bone height in the maxilla
  • signed informed consent after being informed

Exclusion Criteria:

  • smoking of more than 15 cigarettes a day (clinical studies show an increased failure rate of implants in heavy smokers)
  • poor oral hygiene after hygienic phase (Plaque Index over 30 %)
  • active periodontal disease
  • pregnancy or breastfeeding at date of inclusion

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
Active Comparator: Test group
1 Implant, to be placed in the position with greater vertical bone height with a mesial or distal cantilever.
Procedure: 1 Implant
Active Comparator: Control group
2 Implants
Procedure: 2 Implants

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
radiographic bone level
Time Frame: 5 years
The primary endpoint of the study is the radiographic bone level 5 years after insertion.The bone level represents an indicator of the osseointegration and biological success of the implant.
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiographic bone level
Time Frame: 1, 3, 7, 10 years
1, 3, 7, 10 years
Implant survival and success
Time Frame: 1, 3, 5, 7, 10 years
1, 3, 5, 7, 10 years
rate of technical complication
Time Frame: 1, 3, 5, 7, 10 years
technical complications: screw loosenings, screw fractures, framework fractures, veneering ceramic fractures
1, 3, 5, 7, 10 years
rate of biological complications
Time Frame: 1, 3, 5, 7, 10 years
biological complications: mucositis, assessed by bleeding on probing
1, 3, 5, 7, 10 years
Soft tissue changes
Time Frame: 1, 3, 5, 7, 10 years
Soft tissue changes: change in clinical crown length = recession / papilla index
1, 3, 5, 7, 10 years
Patient morbidity
Time Frame: 1, 3, 5, 7, 10 years
VAS scale to assess pain after implant placement
1, 3, 5, 7, 10 years

Collaborators and Investigators

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

Sponsor

University of Zurich

Investigators

  • Principal Investigator: Daniel Thoma, Prof. Dr., Clinic of Reconstructive Dentistry

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)

August 9, 2012

Primary Completion (Actual)

February 26, 2020

Study Completion (Anticipated)

February 28, 2025

Study Registration Dates

First Submitted

July 20, 2012

First Submitted That Met QC Criteria

July 20, 2012

First Posted (Estimate)

July 25, 2012

Study Record Updates

Last Update Posted (Actual)

May 15, 2023

Last Update Submitted That Met QC Criteria

May 12, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 2012-0097

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.

Clinical Trials on Dental Implants

Clinical Trials on 1 Implant

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Burundi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe