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Implant supported maxillary overdentures in the augmented maxilla: 4 versus 6 implants

Implant supported maxillary overdentures in the augmented maxilla: 4 versus 6 implants - 4vs6implants

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON41874
Enrollment
64
Registered
2015-07-15
Start date
2015-09-01
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

edentulous maxilla upperjaw without teeth

Interventions

augmented
implant
maxilla

Sponsors

Amphia Ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: * Informed consent to participate in this study. * Over 18 years of age. * Atrophic edentulous maxilla with insufficient bone to place implants without augmentation procedures (width and height less than 3mm in the lateral parts of the maxilla) Cawood classification IV or higher. * No previous implant procedures in the maxilla. * More than one year edentulous in the maxilla. * Sufficient interocclusal distance to place implants with a bar supported overdenture. * Edentulous, dentate or partial edentulous mandible

Exclusion criteria

Exclusion criteria: * ASA III or higher * Non-regulated diabetes * Use of corticosteroids * Use of bisphosphonates * Active periodontitis in the mandible

Design outcomes

Primary

MeasureTime frame
The main study parameter is functional outcome measured with the MFIQ

Secondary

MeasureTime frame
Costs of the procedures (costs will be measured by operating time multiplied by the costs of a OR per hour, costs of the implants, costs of the meso- andsuprasructure (costs of the dentist (measured by time of the procedures and cost of materials and costs of the dental technician). Change in bone level Clinical parameters (pocket depth, bleeding score and plaque score) Change in facial appearance with VAS-score filled out by patients and evaluated by a panel of maxillofacial surgeons based on the taken photographs. Post operative pain measured with VAS-scores Amount of visits Patient satisfaction Other study parameters * Level of general health (ASA-classification) * Level of dental hygiene * Complications (such as rupture of the sinus membrane and wound dehiscence) * Operating time, bloodloss * Loss of implants Gender Age Medical history Medication

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)