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A multi centre randomized controlled clinical trial comparing conventional loading of an overdenture on two implants with a bar to immediate loading of an overdenture on two implants with a bar.

A multi centre randomized controlled clinical trial comparing conventional loading of an overdenture on two implants with a bar to immediate loading of an overdenture on two implants with a bar. - Active in one day

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON31470
Enrollment
92
Registered
2008-11-07
Start date
2008-11-08
Completion date
Unknown
Last updated
2024-05-13

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

Conditions

Edentate proefpersonen Oral implantology in edentulous patients

Interventions

None listed

Sponsors

Vrije Universiteit
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1) The study object must be fully edentulous for a minimal period of 1 year. 2) The study object must have a minimal intraforaminal bone height of at least 8 mm measured on a lateral cephelometric radiograph. 3) The study object must agree to a treatment allocation in any of the two groups. 4) The study object must have suitable bone quality as assessed radio graphically (Lekholm & Zarb 1985). 5) The implants must be initially stable and inserted with at least 35 ncm torque.

Exclusion criteria

Exclusion criteria: 1) Physical and mental disabilities which interfere with the maintenance of implants; 2) Severe skeletal jaw discrepancies 3) Severe clenching habits 4) Those that have already received or lost implants 5) Those who abuse drugs or alcohol 6) Having received radiotherapy to the head and neck region for malignancies 7) Heaving smokers (more than a packet a day) 8) Undergoing chemotherapy 9) Systemic and local bone disorders and pathology 10) Immuno-compromised patients, including those with HIV

Design outcomes

Primary

MeasureTime frame
During several points in time, the following parameters are registered: - patient satisfaction - total treatment costs - total treatment time - total prosthetic aftercare - bone level around implants by the use of standardized x-rays - periodontal parameters - implant stability

Secondary

MeasureTime frame
Microbiolologic annd genetic factors that might play a role in the etiology of peri-implant infection.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)