To compare, in a randomized controlled clinical trial, titanium and zirconia implants for the replacement of a single upper premolar after 1 and 3 years of function.
ID
Source
Brief title
Condition
- Dental and gingival conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Marginal bone loss as measured on a radiograph after 1 and 3 years compared to
baseline.
Secondary outcome
- plaque accumulation
- calculus
- pocket probing depth
- bleeding on probing
- contentment
Background summary
For the replacement of a missing tooth with an implant, titanium is currently
the biomaterial of choice. Good results have been reported in the literature,
but titanium has some drawbacks as well. The main concern is that it is grey,
which can cause blue-greyish shimmering, which may cause esthetic problems.
Besides, some patients prefer a metal-free sollution. Zirconia may be a good
alternative. Recently a new zirconia implant was launched (Pure Straumann,
Zwitserland), of which expectations are high, but not backed up by evidence
that is, may serve as well as titanium.
Study objective
To compare, in a randomized controlled clinical trial, titanium and zirconia
implants for the replacement of a single upper premolar after 1 and 3 years of
function.
Study design
A randomized clinical trial
Intervention
Placement of a titanium or zirconia implant and the provision of a crown.
Study burden and risks
No risks other than those commonly associated with the placement of an implant
(minor pain and swelling and the chance on implant loss), not different among
both research groups.
For subjects a limited extra investment in time is expected (1 additonal hour).
It is regular care, both the treatment itself and the documentation of the
outcome measures.
A. Deusinglaan 1
Groningen 9731 AV
NL
A. Deusinglaan 1
Groningen 9731 AV
NL
Listed location countries
Age
Inclusion criteria
Missing first or second premolar in the maxilla
Wish to replace the missing premolar with an implant
Bone height >=10 mm beneath the maxillary sinus
Exclusion criteria
Missing teeth mesial or distal from implantation site
Orthodontic treatment at the time of impression taking
Severe bruxism
Acute periodontitis
History of implant loss
Documented extreme gagging reflex
Poor medical condition (ASA* score 3 or higher)35
Previous therapeutic radiation of the head -neck region
Chronic pain in orofacial system
Younger than 18 years at time of inclusion
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 | NL58957.042.16 |