Dental Implant Supported Removable Dental Prostheses

Study Overview
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Brief Summary
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To prospectively monitor the survival rate of Ankylos® dental implants, comparing delayed versus immediate loading, using abutments with the SynCone® concept for implant-supported detachable dental prosthesis (ISDDP) in the edentulous upper jaw.

Official Title
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An Randomized Controlled Trial Comparing Immediate Loading With Conventional Loading Using Cone-anchored Implant Supported Removable Dental Prostheses, a Two Year Follow up

Conditions
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Implant Complication, Prosthesis Survival

Intervention / Treatment
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* Procedure: placement of implants
* Procedure: immediate loading
* Procedure: conventional loading
* Device: Ankylos implant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of informed consent Extraction sockets should have healed at least 4 months Sufficient bone volume to place six implants in the maxilla No previous bone augmentation procedures The mandible can have any kind of dentition as long as a well-distributed contact relationship with the new prosthesis in the maxilla can be established. Accepting to comply with study procedures Exclusion Criteria: Physical or psychological disorders prohibiting implant treatment Heavy smoking (>10 cigarettes/day) Present alcohol and/or drug abuse Physical handicap that may interfere with the ability to perform oral hygiene

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate loading<br> | Procedure: placement of implants<br>* surgical procedure and placement of implants<br>Procedure: immediate loading<br>* cone-anchored implant supported removable dental prostheses placement<br>Device: Ankylos implant<br> <br> |
| Active Comparator: delayed loading<br> | Procedure: placement of implants<br>* surgical procedure and placement of implants<br>Procedure: conventional loading<br>* cone-anchored implant supported removable dental prostheses placement in 3mo<br>Device: Ankylos implant<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bone loss | measured in mm op peri-apical radiography. Mesial and Distal measurement of implant. | Difference between loading and Year two | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| probing pocket depth | Measurement in mm, 4 sites per implant. | Difference between loading and Year two | 
| plaque | presence of plaque, 4 sites per implant, Yes=1 or No=0 | Difference between loading and Year two | 
| bleeding on probing | presence of bleeding on probing, 4 sites per implant, Yes=1 or No=0 | Difference between loading and Year two |