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Maxillary sinus floor augmentation with autogenous bone and bovine bone mineral in the resorbed maxilla: a 1-year multicentre, split-mouth, randomized clinical trial

Maxillary sinus floor augmentation with autogenous bone and bovine bone mineral in the resorbed maxilla: a 1-year multicentre, split-mouth, randomized clinical trial - Cerabone

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON45707
Enrollment
46
Registered
2017-05-09
Start date
2017-08-21
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

Insufficient bone height to place dental implants

Interventions

In all patients billateral maxillary sinus floor augmentation's will be performed Sides will be randomly assigned to: * 1. AB harvested from mandibular ramus * 2. BBM, Cerabone (Cerabone, Botiss Den

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1) Over 18 years of age 2) In need for bilateral dental implant placement in the posterior maxilla. 3) The residual bone height in the posterior maxillar is between 2 and 5 mm. 4) Bone width should be over 5 mm. 5) Enough volume of the mandibular ramus to facilitate bone harvesting.

Exclusion criteria

Exclusion criteria: 1) Presence of clinical active periodontal disease 2) Presence of acute inflammatory oral disease, 3) Smoking 4) Uncontrolled diabetes 5) A history of radiotherapy in the head- and-neck region or current chemotherapy 6) Disability (mental and/or physical) to maintain basic oral hygiene procedures 7) In case of pregnancy the treatment is not performed, but postponed till after pregnancy.

Design outcomes

Primary

MeasureTime frame
Success of MSFA determined by 1-year clinical performance of dental implants placed in augmented maxillary sinus

Secondary

MeasureTime frame
* Volumetric changes of the bone graft * Histological evaluation * Micro-computed tomography (*CT) analysis * Patient satisfaction and pain scores regarding MSFA * Implant survival * Implant success * Prosthetic success * Complications * Plaque, gingival and bleeding indices * Pocket probing depth * Peri-implant radiographic bone levels * Volumetric changes of the bone graft * Patients satisfaction with implant placement and prosthesis

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)