Skip to content

Horizontal maxillary augmentation with autogenous bone Calvaria versus Mandibular Ramus

Horizontal maxillary augmentation with autogenous bone Calvaria versus Mandibular Ramus - Calvaria versus Mandibular Ramus

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON50141
Enrollment
36
Registered
2020-07-30
Start date
2020-08-01
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone resporption Boneloss

Interventions

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 c

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
Primary Objective: Volumetric changes of the different bone grafts

Secondary

MeasureTime frame
Secondary Objective(s): - Histological evaluation: percentage of vital bone (bone sample after 6 months) - Patient related outcomes: satisfaction and pain - Complications/morbidity donor sites

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)