The aim of this study is to compare the success of horizontal bone augmentation treatments with autogenous bone harvested from the calvaria area and autogenous bone harvested from the mandibular ramus.
ID
Source
Brief title
Condition
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary Objective:
Volumetric changes of the different bone grafts
Secondary outcome
Secondary Objective(s):
- Histological evaluation: percentage of vital bone (bone sample after 6
months)
- Patient related outcomes: satisfaction and pain
- Complications/morbidity donor sites
Background summary
Implantology in the atrophic edentulous maxilla can be challenging. Bone
resorption after tooth loss because of trauma and periodontal or endodontic
pathology is a frequent finding that complicates dental implant placement
(Juodzbalys & Kubilius 2013, Sharan & Madjar 2008). In cases of severe bone
resorption in the maxilla, a sinus lift procedure with vertical and horizontal
bone augmentation may be required. Maxillary sinus floor augmentation for the
placement of implants are originally described by Boyne and James (1980) and
Tatum (1986). Nowadays, these augmentations are a commonly performed and
successful procedure for the reconstruction of the edentulous posterior maxilla
(Del Fabbro, et al. 2013, Esposito, et al. 2014, Wallace & Froum 2003).
To create sufficient height and width, maxillary augmentation is performed with
autogenous bone, bone substitutes or a mixture of both, such as bovine bone
mineral (Esposito, et al. 2014). The autogenous bone grafts are considered as
"gold standard". (Sakkas et al, 2017) The success of autografts mainly depends
on the osteogenicity of the graft, stability and adaptation of the graft to the
recipient side (Hallman & Thor 2008, Misch & Dietsh 1993). Different donor
sites are used to harvest bone material. Iliac crest and calvaria bone are
identified as the most common extra oral sites, and mandibular ramus and chin
bone are most often used as intra oral donor sites. Little is known about the
differences between the types of bone. Though, autogenous bone, especially the
extra oral sites, has major drawbacks such as, considerable morbidity at the
donor side.
Study objective
The aim of this study is to compare the success of horizontal bone augmentation
treatments with autogenous bone harvested from the calvaria area and autogenous
bone harvested from the mandibular ramus.
Study design
Single center, randomized controlled trial.
Intervention
A bilateral maxillary augmentation will be performed in 54 patients with a
resorbed posterior maxilla. The three-dimensional alveolar ridge augmentation
will be performed with calvaria bone blocks compared to mandibular ramus
intraoral autogenous bone graft mixed with xenograft (BioOss, Geistlich,
Switzerland, Wolhusen) in individualized titanium meshes (ReOss, Germany,
Filderstadt). Maxillary sinus floor augmentation will be performed with
autologous bone (bone chips anterior maxillary sinus) and xenograft (BioOss).
Study burden and risks
No extra burden for the participants, except for a very short, non-invasive
questionnaire.
Doctor Molewaterplein 40 Doctor Molewaterplein 40
Rotterdam 3015 GD
NL
Doctor Molewaterplein 40 Doctor Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
1. Patients of 18 years and older and in need for bilateral dental implant
placement in the posterior maxilla
2. Atrophic maxilla; horizontal bone deficiency of less than 4 mm of the
alveolar ridge in the horizontal plane (class III, IV atrophy according to
Cawood and Howell classification)
3. Enough volume of the mandibular ramus to facilitate bone harvesting
4. Absence of visible active inflammation
Exclusion criteria
1. Medical condition that contraindicates surgery; from ASA III
2. History of radiotherapy in the head and neck region
3. History of Bisphosphonate medication (intravenous)
4. History (within the last 3 months) of using (at least weekly or more
frequently) smokeless chewing tobacco, smoking a pipe, cigar or cigarette (at a
rate of more than10 cigarettes per day)
5. Disability (mental and/or physical) to maintain basic oral hygiene
procedures
6. Unhealed extraction sites (less than 6 weeks post extraction)
7. Patients unwilling or incapable of understanding and signing the informed
consent
8. Patients who are pregnant
Design
Recruitment
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 | NL73146.078.20 |