Bone adaptation induced by non-passively fitting implant superstructures
| ISRCTN | ISRCTN51714535 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN51714535 |
| Secondary identifying numbers | N/A |
- Submission date
- 22/05/2009
- Registration date
- 15/07/2009
- Last edited
- 20/01/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
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
Contact information
Scientific
Zahnklinik 2 - Department of Prosthodontics
University of Erlangen-Nuremberg
Glueckstrassse 11
Erlangen
91054
Germany
 ORCID ID |
0000-0002-8748-1024 |
|---|---|
| Phone | +49 (0)913 1853 5802 |
| Matthias.Karl@uk-erlangen.de |
Study information
| Study design | Randomised controlled clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Bone adaptation induced by non-passively fitting implant superstructures: a randomised controlled clinical trial |
| Study objectives | 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(s) | Ethics Committee of the Medical Faculty of the Friedrich-Alexander-University Erlangen-Nuremberg, 10/02/2009, ref: 3933 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | 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 study start date | 01/07/2009 |
| Completion date | 30/06/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | All |
| Sex | Both |
| Target number of participants | 20 |
| Key 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. |
| Key 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 |
| Date of first enrolment | 09/07/2009 |
| Date of final enrolment | 05/12/2013 |
Locations
Countries of recruitment
- Germany
Study participating centre
91054
Germany
Sponsor information
Research organisation
c/o Professor Dr. Thomas D. Taylor
Department of Reconstructive Sciences
263 Farmington Avenue
Farmington
Connecticut
06030-1615
United States of America
| Phone | +1 (0)860 679 2649 |
|---|---|
| ttaylor@nso.uchc.edu | |
| Website | http://www.uconn.edu/ |
"ROR" |
https://ror.org/01dkem006 |
Funders
Funder type
Research organisation
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | A manuscript has been submitted to “The International Journal of Oral and Maxillofacial Implants” |
| IPD sharing plan |
