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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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON27028
Enrollment
46
Registered
2017-09-09
Start date
2017-08-21
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Maxillary sinus floor augmentation, autogenous bone, bovine bone material, oral implants

Interventions

The study will be designed as a multicenter, split-mouth, randomized split mouth study.: Randomisation will be carried out between two sides: 1. AB harvested from mandibular ramus 2. BBM, Cerabone (

Sponsors

-University Medical Centre Erasmus MC, Rotterdam, -St. Anna Hospital, Geldrop -Catharina Hospital, Eindhoven. -St. Antonius Hospital, Nieuwegein
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: -18 years and older -In need for bilateral dental implant placement in the posterior maxilla -Bone height should be more then 2 mm and less then 5 mm -Bone width should be over 5 mm -Enough volume of the mandibular ramus to facilitate bone harvesting.

Exclusion criteria

Exclusion criteria: Presence of clinical active periodontal disease Acute inflammatory oral disease Smoking Uncontrolled diabetes A history of radiotherapy in the head- and-neck region or current chemotherapy

Design outcomes

Primary

MeasureTime frame
Success of the MSFA procedure 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 (μCT) 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

Contacts

Public ContactB.P. Jonker

Department of Oral & Maxillofacial Surgery, Special Dental Care and Orthodontics

e-mail: b.jonker@erasmusmc.nlTel + 31 10 703 4138

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)