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A clinical, prospective feasibility study to assess the effectiveness and safety of micro-structured TCP granules as a bone augmentation material in sinus floor elevation procedures.

A clinical, prospective feasibility study to assess the effectiveness and safety of micro-structured TCP granules as a bone augmentation material in sinus floor elevation procedures. - The effectiveness of micro-structured TCP granules as a bone graft.

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON32900
Enrollment
10
Registered
2009-01-26
Start date
2011-01-10
Completion date
Unknown
Last updated
2024-05-06

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

Conditions

Tandheelkundige behandeling boneloss Upper jaw augmentation

Interventions

Patients fulfilling all in- and exclusion criteria will be requested for informed consent and scheduled for sinus floor elevation surgery. At surgery patients will undergo sinus augmentation with mi

Sponsors

Universitair Medisch Centrum Sint Radboud
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: •Male or female patients aged 18-70 years •Patient is willing to give informed consent to participate in the study •Patient qualifies for sinus augmentation surgery •Presence of a maxillary, unilateral or bilateral, (partial) edentulism involving the premolar/molar areas •Presence of a residual alveolar ridge height between 3 and 8 mm

Exclusion criteria

Exclusion criteria: •Maxillary sinus pathology •Recent extractions in the involved area •Presence of a local or systemic disease or treatment affecting bone formation •Contamination of the (area around the) operative field •Infectious diseases •Bone metabolic disease •Psychologic instability •Neurological disorders that could influence mental validity •Female of child bearing potential, who are pregnant or breast-feeding •Cancer therapy including immune-suppression, chemotherapy and radiation •Patients in which primary stability could not be established •Previous entry into this study or participation in any other clinical trail within 30 days

Design outcomes

Primary

MeasureTime frame
•Percentage of new bone formation will be evaluated by micro-CT and histological analysis of biopsy specimens; for each biopsy from each patient at 5 months after augmentation surgery •Function of the inserted endosseous dental implants, at different time-intervals after surgery •Pain •Health related quality of life (SF-36) •Economical evaluation

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)