The aim of this study to evaluate the clinical performance of short implants (4 mm in length) in the resorbed posterior mandibular region of partially edentulous patients that will be restored with a single crown.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
kauwstelsel, orale functie en comfort
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Mean marginal bone loss, clinical performance, implant survival
Secondary outcome
Patient satisfaction (OHIP-NL 49, SF-36, VAS-Score)
Background summary
Dental implant placement requires a minimal amount of available alveolar bone
volume, both in terms of bone width as in height. If this is lacking,
traditionally regular sized implants are placed after vertical augmentation of
the jaw. Such treatment is relatively invasive with subsequent morbidity. More
recently, a switch has been made to the use of short implant, circumventing the
need for augmentation. The implants which become available to the market become
increasingly shorter.
Study objective
The aim of this study to evaluate the clinical performance of short implants (4
mm in length) in the resorbed posterior mandibular region of partially
edentulous patients that will be restored with a single crown.
Study design
A prospective case series.
Intervention
Placement of a 4mm dental implant in the resorbed posterior mandible to support
a single crown
Study burden and risks
The burden to participate in this study is low since the treatment as
conventional implant treatment if offered without augmentation. One extra visit
is necessary to sign the informed consent and to give the patient time to
consider the decision of participation. All other visits are regular, when
treated with implants. The x-rays taken to evaluate the bone height around the
implant is also a standard procedure after implant insertion.
The use of this 4mm implant for a single crown will be off-label since the
producer recommends blocking two implants. But in case of insufficient bone the
placement of a longer implant would require a bone augmentation which is
expensive and causes a relatively high morbidity with unpredictable outcome.
Therefore insertion of a longer implant won*t be a good alternative for the
anticipated patients.
The main risk of this type of short implant is that it will be lost in case of
severe bone resorption (due to peri-implantitis). Of course this process of
inflammation and subsequently bone resorption will take a longer time in case
of a longer implant. But the risk of getting peri-implantitis is the same for
all lengths.
In case of severe bone loss the implant becomes loose and can be removed
easily. Damage to the tissues will be smaller in case of a short implant
compared to a long implant.
The risk of fracture of the implant neck is de same as for longer implants
since the diameter of the neck is exactly the same. This is a rare problem.
Therefore this risk is negligible. But in case of a fracture the implant can be
removed by a removal tool and the damage to the tissues will be smaller
compared to the removal of a longer implant.
In short, the patient will benefit from this treatment since there are no good
alternatives. The treatment will be offered as an regular treatment with no
reduction in costs.
Antonius Deusinglaan 1
Groningen 9713AV
NL
Antonius Deusinglaan 1
Groningen 9713AV
NL
Listed location countries
Age
Inclusion criteria
- The patient is 18 years or older;
- The missing or lost tooth is a premolar or a molar in the mandible;
- Sufficient healthy and vital bone to insert a dental implant with a length of 4.0 mm;
- The implant site must be free from infection;
- Adequate oral hygiene (modified plaque index and modified sulcus bleeding index)
- 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;
- A history of local radiotherapy to the head and neck region;
- Sufficient healthy and vital bone to insert a dental implant longer than a length of 4.0 mm.
-previously treatment with an implant at the same location followed by implant-loss
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
In other registers
| Register | ID |
|---|---|
| CCMO | NL47216.042.13 |
| OMON | NL-OMON23139 |