Condition category
Oral Health
Date applied
22/05/2009
Date assigned
15/07/2009
Last edited
20/01/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
A dental prosthesis is used to repair defects such as missing teeth and missing parts of teeth. A dental implant is a titanium screw that is placed into the jawbone to support a dental prosthesis. Dental prostheses fixed on more than one dental implant are supposed to have a perfect, passive fit in order to avoid mechanical stress which may cause problems. Unfortunately, passivity of fit cannot be achieved with current materials and techniques. The aim of this study was to show that the jawbone adapts to stresses caused by implant-supported prostheses.

Who can participate?
Healthy patients who have lost teeth and are going to receive an implant-supported prosthesis.

What does the study involve?
Two dental implants will be placed in the patients' edentulous sites (i.e., where teeth are missing). The patients will be randomly allocated to one of two groups. Different techniques will be used to fit the fixed prosthesis in the two groups. Over six months seven strain gauge measurements will be carried out. Upon completion of the measurements, the implants will be restored in a definitive way.

What are the possible benefits and risks of participating?
Patients receive dental implants for free and are reimbursed for travel expenses and time spent during the strain gauge measurement sessions. Risks include potential bone damage due to repeated fixation of the prosthesis, and small implant components as well as impression material might be swallowed or aspirated during the course of the study.

Where is the study run from?
University of Erlangen-Nuremberg (Germany).

When is the study starting and how long is it expected to run for?
July 2009 to June 2014.

Who is funding the study?
ITI Foundation (Switzerland).

Who is the main contact?
Dr Matthias Karl
Matthias.Karl@uk-erlangen.de

Trial website

Contact information

Type

Scientific

Primary contact

Dr Matthias Karl

ORCID ID

http://orcid.org/0000-0002-8748-1024

Contact details

Zahnklinik 2 - Department of Prosthodontics
University of Erlangen-Nuremberg
Glueckstrassse 11
Erlangen
91054
Germany
+49 (0)913 1853 5802
Matthias.Karl@uk-erlangen.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Bone adaptation induced by non-passively fitting implant superstructures: a randomised controlled clinical trial

Acronym

Study hypothesis

Non-passively fitting implant-supported fixed dental prostheses induce bone adaptation which leads to the displacement of the supporting implants and a reduction of misfit. Restorations fabricated by an intra-oral luting technique evoke only minimal misfit strains and thus do not lead to bone remodelling.

Ethics approval

Ethics Committee of the Medical Faculty of the Friedrich-Alexander-University Erlangen-Nuremberg, 10/02/2009, ref: 3933

Study design

Randomised controlled clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Precision of fit of implant-supported dental restorations

Intervention

Two dental implants will be placed in the patients' edentulous sites and restored with a fixed prosthesis (measurement restoration). The design of the pontic area will allow for a strain gauge to be positioned temporarily. Within a period of six month, seven strain gauge measurements will be done. The patients will be randomly allocated to either the fit or misfit group. In the misfit group, conventional screw retained superstructures will be used whereas in the fit group screw-retained restorations fabricated by an intra-oral luting technique will be applied. Upon completion of the strain gauge measurements, the implants will be restored in a definitive way.

Intervention type

Device

Phase

Drug names

Primary outcome measures

Trend in strain development for each restoration over time. Strain measurements will be done in each patient every 4 weeks for a period of 6 months.

Secondary outcome measures

Differences in strain development between fit and misfit group. Strain measurements will be done in each patient every 4 weeks for a period of 6 months.

Overall trial start date

01/07/2009

Overall trial end date

30/06/2014

Reason abandoned

Eligibility

Participant inclusion criteria

Partially edentulous, healthy patients (any age, either sex) who have been treatment planned to receive an implant-supported multi-unit fixed dental restoration in one or two quadrants.

Participant type

Patient

Age group

All

Gender

Both

Target number of participants

20

Participant exclusion criteria

1. Contraindications for dental implants (e.g., craniofacial growth is not finished)
2. Impaired general health
3. Diseases and medications affecting bone quality
4. Untreated periodontal disease
5. Insufficient bone volume for implant placement

Recruitment start date

09/07/2009

Recruitment end date

05/12/2013

Locations

Countries of recruitment

Germany

Trial participating centre

University of Erlangen-Nuremberg
Erlangen
91054
Germany

Sponsor information

Organisation

ITI Foundation (Switzerland)

Sponsor details

c/o Professor Dr. Thomas D. Taylor
Department of Reconstructive Sciences
263 Farmington Avenue
Farmington
Connecticut
06030-1615
United States of America
+1 (0)860 679 2649
ttaylor@nso.uchc.edu

Sponsor type

Research organisation

Website

http://www.uconn.edu/

Funders

Funder type

Research organisation

Funder name

ITI Foundation (Switzerland) (ref: 579-2008)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

A manuscript has been submitted to “The International Journal of Oral and Maxillofacial Implants”

Intention to publish date

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes