Primary Objective: To compare peri-implant hard and soft tissue changes as measured on standardized intraoral radiographs and direct digital intraoral scans between the group of single final and and the group of multiple repeated abutment dis/re-…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Healed extraction site
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To compare hard and soft tissue changes
Secondary outcome
-peri-implant microbiological evaluation.
-evuation of guided surgery accuracy
Background summary
To overcome the obstacles posed by repeated dis/re connections, a concept for
immediate final abutment placement at implant surgery was developed (Canullo
2010), referred to as initially as *one abutment- one time*. Few recent reports
have demonstrated the applicability of the one abutment- one time concept in
the clinical situation (Degidi et al. 2011; Grandi et al. 2012; Degidi et al.
2013; Canullo 2010), with follow ups up to 3 years, measured in standardized
periapical radiographs. However, the influence of several parameters in this
*one abutment one time* concept on the gingival contour volume maintenance and
peri-implant alveolar bone resorption rate are yet to be investigated .
To connect the final abutment at implant placement, the implant should be
inserted in the ideal 3-dimensional and prosthetically driven position. For
this purpose, guided surgery might be a useful tool. The goal of computer-aided
implant surgery is to minimize the error in implant positioning compared to
manual or conventional surgical guide implant placement (Yamada et al. 2011),
accomplishing optimal implant localization and reducing the risk of damage to
adjacent structures (Brief et al. 2005). Additionally, it facilitates flapless
surgery and immediate abutment tightening.
Study objective
Primary Objective:
To compare peri-implant hard and soft tissue changes as measured on
standardized intraoral radiographs and direct digital intraoral scans between
the group of single final and and the group of multiple repeated abutment
dis/re- connections.
Secondary Objective:
- To measure and compare the microbiological flora around the abutments between
the two groups through culturing of the periodontal samples.
- To evaluate the precision of the Nobel Clinicians ® guided implant surgery by
superimposing the volumetric 3D models between the planned and the placed
implant position.
- To compare the following clinical parameters between the two groups:
Peri-implant pocket depth, bleeding on probing and plaque percentage.
Study design
The study design is a prospective randomized controlled clinical trial (RCT).
Patients in need of one single implant in the (pre)molar region of the upper
jaw, who fulfill the inclusion/exclusion criteria (see section 3.1.1 and 3.1.2)
will be enrolled in the study.
Randomization will allocate patients into two groups: The test group will have
final abutments placed and torqued at implant placement (from now on referred
to as test group: TG), and the control group will follow a conventional
protocol with healing abutments placed at implant placement and dis/re-
connected multiple times (from now on referred to as control group: CG).
Soft and hard tissue behaviour changes will be analyzed and followed up at 3, 6
and 12 months following implant placement.
Intervention
N/A
Study burden and risks
This study is a non-interventional study and therefore the risks are
negligible. Both approaches as outlined in this protocol are routinely applied
in the clinic and this study aims to compare both approaches in a scientific
manner.
Because of the non-interventional nature of this study, also no additional
benefits are expected for the subjects.
Gustav Mahlerlaan 3004
Amsterdam 1081 LA
NL
Gustav Mahlerlaan 3004
Amsterdam 1081 LA
NL
Listed location countries
Age
Inclusion criteria
1. Patients of at least 25 years of age and who are able to sign an informed consent.
2. In need of a single implant.
3. Healed site (healed site defined by restored gingiva, free of inflammation and scar tissue (Zuhr, Hurzeler 2012. Book), with a keratinized band of 3mm from crest to muco-gingival junction, and sufficient osseous architecture to receive an implant (Koutouzis 2013) with a minimal diameter of 3.5 mm).
4. (Pre)molar region.
5. At least one neighbouring tooth is present.
6. Absence of visible active periapical or periodontal inflammation.
7. Adequate oral hygiene: PI< 20%, BoP< 20%.
8. Sufficient occlussal units mesial or distal and antagonizing, including the diastema to
be restored: 4 occlusal units.
Exclusion criteria
1. Medical condition that contraindicates surgery: ASA -score >= III
2. History of radiotherapy in the head and neck region.
3. History of Biphosphonate medication.
4. Medium smokers >= 10 cigarettes per day.
5. Patients unwilling or incapable of signing the informed consent.
6. Active caries
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 | NL50019.029.14 |