To compare the efficacy of two different techniques for the augmentation of the atrophic maxilla.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Protheseinsufficiƫntie ivm atrofie van de maxilla
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the difference of the amount of bone formation,
measured with a cone beam CT, between the two sides of the maxillary sinuses.
A cone beam CT will be made pre-operative and 4 months post-operative. One last
cone beam CT will be produced 4 months after implant insertion.
The bone quality will be evaluated by bone histology, taken at the moment of
implant placement.
Secondary outcome
Other endpoints will be implant survival, prosthetic survival and patient*s
satisfaction.
Background summary
At the department Cranio-Maxillofacial Surgery of Maastricht University Medical
Center (MUMC) the routine procedure for sinus floor elevation prior to dental
implant insertion is augmentation with a mixture of autogenous bone and
xenogenous bone, which adds morbidity due to the donorsite.
We want to augment the maxillary sinuses without using any substitutes by
placing only a resorbable barrier to elevate the Schneiderian membrane of the
floor of the sinus. Bone will be regenerated using the periosteal capacity of
osteoinduction.
Hypothesis: In the atrophic maxilla periosteal elevation with a resorbable
membrane in the sinuses creates sufficient and reliable bone for later dental
implant insertion.
Study objective
To compare the efficacy of two different techniques for the augmentation of the
atrophic maxilla.
Study design
This is a pilot randomised controlled clinical trial
Intervention
This will be a split mouth study design. The sinus will be approached by the
lateral window technique. On one side a resorbable barrier will be placed to
create a space which will be replaced through newly formed bone. On the other
side a mixture of autogenous bone from the crista iliaca anterior and xenogenic
bone is used to augment the sinus.
Study burden and risks
The patient must visit the clinic as often as in a standard treatment. No extra
visits are needed.
The benefit of participating in this study is less donor site morbidity,
because only half of the amount of autogenous bone is grafted. Second benefit
is that the risk related to the use of xenogenous bone substitutes is reduced
(slow sinus infections, Creutzfeldt-Jakob disease, etc.).
The risk associated with participation is the presence of insufficient bone in
the sinus site with periosteal elevation. In this scenario a second surgery may
be needed.
P. Debeyelaan 25
Maastricht 6202 AZ
NL
P. Debeyelaan 25
Maastricht 6202 AZ
NL
Listed location countries
Age
Inclusion criteria
18-75 years old
Edentulous
Residual bone heights of 1-8 mm
Bone width of at least 5 mm
Exclusion criteria
Contraindications for general anaesthesia
History of radiotherapy in the head/neck region
Treated with bisphosphonates
Poor oral hygiene
Uncontrolled diabetes
Pregnancy
Infection
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 | NL41286.068.12 |
OMON | NL-OMON21889 |