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

Study Overview
=================
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.

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

Conditions
-----------------
Dental Implants

Intervention / Treatment
-----------------
* Procedure: 1 Implant
* Procedure: 2 Implants


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Test group<br>1 Implant, to be placed in the position with greater vertical bone height with a mesial or distal cantilever. | Procedure: 1 Implant<br> <br> |
| Active Comparator: Control group<br>2 Implants | Procedure: 2 Implants<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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