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

Not Applicable

Active, not recruiting

• Conditions: Dental Implants

• Registration Number: NCT01649531
• Lead Sponsor: University of Zurich

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-07-20
• Study First Submitted QC: 2012-07-20
• Study First Posted: 2012-07-25
• Study Start: 2012-08-09
• Primary Completion: 2020-02-26
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-12
• Last Update Posted: 2023-05-15
• Study Completion: 2025-02-28

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
radiographic bone level	5 years	The 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 Outcome Measures

Name	Time	Method
Radiographic bone level	1, 3, 7, 10 years
rate of technical complication	1, 3, 5, 7, 10 years	technical complications: screw loosenings, screw fractures, framework fractures, veneering ceramic fractures
rate of biological complications	1, 3, 5, 7, 10 years	biological complications: mucositis, assessed by bleeding on probing
Soft tissue changes	1, 3, 5, 7, 10 years	Soft tissue changes: change in clinical crown length = recession / papilla index
Implant survival and success	1, 3, 5, 7, 10 years
Patient morbidity	1, 3, 5, 7, 10 years	VAS scale to assess pain after implant placement

Trial Locations

Locations (1)

Center of Dental Medicine Clinic of Reconstructive Dentistry; 🇨🇭 Zurich, Switzerland