To investigate the influence of different implant neck designs on marginal peri-implant bone levels and clinical variables.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Aandoeningen aan het gebit
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Changes in marginal peri-implant bone loss
Secondary outcome
Clinical performance, namely:
-Implant survival.
-Implant Crown Aesthetic Index. One month and one and five year after placement
of the final restoration, the Implant Crown Aesthetic Index is assessed as
described by Meijer et al., 2005. The aesthetic index is assessed on
standardized photographic images, taken according to Meijndert et al., 2004.
-Modified Plaque-index and Modified Bleeding-Index (Mombelli et al., 1987),
Gingiva index (Loë and Silness, 1963). These parameters are evaluated
pre-operative, one month and one and five year after placement of the
definitive restoration. The adjacent teeth are counted as well in the
assessments.
-Papil-index (Jemt et al., 1997). This index is evaluated pre-operative, one
month and one and five year after definitive restoration. The Papil-index is
assessed on the standardized photographic images.
-Probing depth. Probing of the implant and the adjacent teeth is performed at
three sites, buccodistal, buccomedial, buccomesial. The probing depth is
measured pre-operative, one month and one and five year after placement of the
definitive restoration.
-Recession. The degree of recession is measured on the standardized
photographic images. Therefore the distance is measured between the most
cervical and mediobuccal point of the marginal gingiva perpendicular to the
incisal edge of the definitive crowns one week and one year after placement.
The adjacent teeth are counted as well in the measurements. Also the distance
between the most coronal point of the mesial and distal papil perpendicular to
the incisal edge of the natural adjacent tooth is determined. This is done on
the standardized photographic images taken pre-operative, one month and one and
five year after definitive restoration.
-Width of keratinized epithelium. The width in millimetres of keratinized
epithelium is measured pre-operative, one month and one and five year after the
definitive restoration has been placed. This is done by using a periodontal
probe.
-Patient satisfaction. Patients are asked to complete a questionnaire measuring
their satisfaction with the aesthetic and functional outcome of the treatment
one month and one and five year after definitive restoration. Also, patient
satisfaction concerning the partial removable denture is measured
pre-operatively.
Background summary
The application of dental implants for single-tooth replacements has evolved
into a viable prosthodontic alternative to conventional fixed bridgework,
resin-bonded restorations or removable partial dentures. Long-term studies have
reported excellent implant survival rates when applied for single-tooth
replacements. Psychological benefits and tooth structure conservation adjacent
to the tooth to be replaced, are among the advantages of implant supported
restorations.
Because of the high levels of survival, the focus of attention is moving from
*survival* to *quality of survival* and the aesthetics are becoming the measure
of success. This involves the establishment of a soft tissue contour that is
harmonious with the gingiva of the adjacent teeth and a crown in balance with
the adjacent dentition.
Over the past years, implant manufacturers have introduced several small
implant modifications to obtain an optimal and stable soft tissue appearance.
Preservation of the marginal peri-implant bone is the major factor on which
these alterations are founded. Nowadays, most implant systems use machined
implant necks (a *smooth implant neck*), due to the fact that rough surfaces
accumulate and retain more plaque than smooth surfaces. However, some studies
have shown that an implant neck with a rough surface shows less marginal bone
loss compared to a smooth implant neck. Therefore, implants with a rough
implant neck were introduced. Another modification that was introduced was the
scalloped implant platform. This platform was designed to preserve the
interdental osseous peaks that support the soft tissue. Comparing to implants
with a traditional flat platform, the scalloped implant mirrors these
interdental osseous peaks.
To date, no randomized clinical trials have been published in which these
different implant neck designs were investigated for the restoration of a
single missing tooth in the anterior dentition.
Study objective
To investigate the influence of different implant neck designs on marginal
peri-implant bone levels and clinical variables.
Study design
Randomized clinical trial
Intervention
For this study, three different study groups are introduced. Patients allocated
to the first study group were treated with a Replace Select Tapered implant
(Nobel Biocare AB, Gothenburg, Sweden) (smooth implant neck topography).
Patients allocated to the second study group were treated with a Nobel Replace
Tapered implant (Nobel Biocare AB)(rough implant neck topography). Patients
allocated to the third study group were treated with a Nobel Perfect implant
(Nobel Biocare AB)(scalloped implant neck topography).
Study burden and risks
One implant type might lead to less peri-implant marginal bone loss than an
other type. There are no further risks involved, since it is a regular dental
treatment. The extra load for the patients is filling in a questionnnaire and
the making of photographs.
Hanzeplein 1
Groningen 9700 RB
NL
Hanzeplein 1
Groningen 9700 RB
NL
Listed location countries
Age
Inclusion criteria
-The patient is 18 years or older;
-The missing or lost tooth is an incisor (central or lateral), a canine or a first premolar in the maxilla. The adjacent teeth are natural teeth;
-Sufficient healthy and vital bone to insert a dental implant with a minimum length of 10 mm and at least 3.5 mm in diameter. In case of insufficient bone volume, a bone augmentation procedure will be performed with autologue bone. After three months of healing, the dental implant will then be inserted;
-The implant site must be free from infection;
-Adequate oral hygiene (modified plaque index and modified sulcus bleeding index <= 1);
-Sufficient mesio-distal, bucco-lingual, and interocclusal space for placement of an anatomic restoration;
-The patient is capable of understanding and giving informed consent.
Exclusion criteria
-Medical and general contraindications for the surgical procedures;
-Presence of an active and uncontrolled periodontal disease;
-Bruxism;
-Site of implant placement is an extraction wound younger than three months;
-Smoking (patients who stop smoking six weeks before the operation can be included);
-A history of local radiotherapy to the head and neck region.
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 | NL31369.042.10 |