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

Dental Implants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01649531
• Other study ID #: 2012-0097
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 9, 2012
• Est. completion date: February 28, 2025

Study information

• Verified date: May 2023
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 36
• Est. completion date: February 28, 2025
• Est. primary completion date: February 26, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Implants

Intervention

Procedure:
• 1 Implant

• 2 Implants

Locations

Country	Name	City	State
Switzerland	Center of Dental Medicine Clinic of Reconstructive Dentistry	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

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