We aim to compare the clinical performance of zirconia stock and CAD-CAM produced implant abutments (experimental group) after one year of function. After one year, the abutments and crowns are removed and subjected to a static bending test in vitro…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Vervanging van ontbrekende gebitselementen door middel van een implantaatkroon
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome variables are:
1. resistance to static loading bending strength in Newton), comparing
experimental stock and CAD-CAM abutments to pristine implant-abutment copies,
under the null hypothesis that they are similar (BS);
2. patients* preference, comparing the digital or conventional impression
technique as measured on a Visual Analogue Scale, under the null hypothesis
that they are similar (PP).
Secondary outcome
Secondary outcome variables relate to clinical performance of the implant and
crown. Routine clinical parameters are compared between stock and CAD-CAM
abutments after one year, namely:
- Probing Pocket Depth (PPD);
- Bleeding on marginal probing (BOP);
- Recession of the mucosa (REC, difference between the value at placement of
the crown and after one year).
Background summary
Implants are applied in partial edentulous patients to great success and seem
the ideal restorative treatment alternative in partially edentulous cases
(Pjetursson et al, 2004). Oral implants are placed into the alveolar bone. They
support the permucosal implant abutment and crown which are screwed on to the
osseointegratded implant. An implant fixed restoration ideally mimics the
unrestored natural tooth in all its aspects and blends in with its
surroundings. Healthy and geometrically stable soft tissues around the implant
crown should be established and maintained for long term service of the implant
(Berglundh et al, 1991; Lindquist et al, 1996). The optimal geometry and choice
of biomaterial used for implant abutments are relevant to the aesthetic and
functional result of treatment.
Study objective
We aim to compare the clinical performance of zirconia stock and CAD-CAM
produced implant abutments (experimental group) after one year of function.
After one year, the abutments and crowns are removed and subjected to a static
bending test in vitro. The specimen with one year of clinical service are
compared to pristine exact copies which serve as controls. For the implant
crowns to be made, both conventional and digital impressions are made. We study
patient*s preference.
Study design
A unicenter randomized clinical trial. Pilot study
Intervention
Implant placement and the provision of an implant-retained crown.
Study burden and risks
Approximately 3 hours of extra time spent, no additional burden.
A. Deusinglaan 1
Groningen 9731 AV
NL
A. Deusinglaan 1
Groningen 9731 AV
NL
Listed location countries
Age
Inclusion criteria
- patients should be over 18 years of age, in reasonable to good general health, as expressed by an ASA-score I or II (de Jong and Abraham-Inpijn, 1994);
- bone volume should allow the placement of implants with a minimum length of 8 mm and minimum diameter of 3.5 mm;
Exclusion criteria
- Previous implant loss
- Irradiation to the maxilla or mandible
- Bruxism
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL42288.042.12 |