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Two Implants Versus One Implant With a Cantilever - a Randomized Controlled Clinical Trial

Two Implants Versus One Implant With a Cantilever - a Randomized Controlled Clinical Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01649531
Enrollment
36
Registered
2012-07-25
Start date
2012-08-09
Completion date
2025-02-28
Last updated
2023-05-15

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

Conditions

Dental Implants

Brief summary

The aim of the present study is to test whether there is a difference in the marginal bone level change between implants with and without cantilevers.

Interventions

PROCEDURE1 Implant
PROCEDURE2 Implants

Sponsors

University of Zurich
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* male and female patients 18 years to 80 years of age * no general medical condition which represents a contraindication to implant treatment * two adjacent missing teeth in the maxilla or mandible in positions of premolars and molars * at least one tooth present adjacent to the edentulous space * indication for implant treatment is given * at least 8 mm of vertical bone height in the mandible allowing for the placement of a 6 mm implant (2 mm safety distance to inferior alveolar nerve) * at least 4 mm of vertical bone height in the maxilla * signed informed consent after being informed

Exclusion criteria

* smoking of more than 15 cigarettes a day (clinical studies show an increased failure rate of implants in heavy smokers) * poor oral hygiene after hygienic phase (Plaque Index over 30 %) * active periodontal disease * pregnancy or breastfeeding at date of inclusion

Design outcomes

Primary

MeasureTime frameDescription
radiographic bone level5 yearsThe primary endpoint of the study is the radiographic bone level 5 years after insertion.The bone level represents an indicator of the osseointegration and biological success of the implant.

Secondary

MeasureTime frameDescription
Implant survival and success1, 3, 5, 7, 10 years
rate of technical complication1, 3, 5, 7, 10 yearstechnical complications: screw loosenings, screw fractures, framework fractures, veneering ceramic fractures
Radiographic bone level1, 3, 7, 10 years
Soft tissue changes1, 3, 5, 7, 10 yearsSoft tissue changes: change in clinical crown length = recession / papilla index
Patient morbidity1, 3, 5, 7, 10 yearsVAS scale to assess pain after implant placement
rate of biological complications1, 3, 5, 7, 10 yearsbiological complications: mucositis, assessed by bleeding on probing

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026