Dental Implant Supported Removable Dental Prostheses

Not Applicable

Completed

• Conditions: Prosthesis Survival; Implant Complication
• Interventions: Procedure: placement of implants; Procedure: immediate loading; Procedure: conventional loading; Device: Ankylos implant

• Registration Number: NCT03041597
• Lead Sponsor: KU Leuven

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09-01
• Primary Completion: 2013-12-31
• Study Completion: 2015-12-31
• Study First Submitted: 2017-01-26
• Status Verified: 2017-02
• Study First Submitted QC: 2017-02-01
• Last Update Submitted: 2017-02-01
• Study First Posted: 2017-02-03
• Last Update Posted: 2017-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
delayed loading	Ankylos implant	-
Immediate loading	immediate loading	-
delayed loading	conventional loading	-
Immediate loading	Ankylos implant	-
delayed loading	placement of implants	-
Immediate loading	placement of implants	-

Primary Outcome Measures

Name	Time	Method
bone loss	Difference between loading and Year two	measured in mm op peri-apical radiography. Mesial and Distal measurement of implant.

Secondary Outcome Measures

Name	Time	Method
plaque	Difference between loading and Year two	presence of plaque, 4 sites per implant, Yes=1 or No=0
probing pocket depth	Difference between loading and Year two	Measurement in mm, 4 sites per implant.
bleeding on probing	Difference between loading and Year two	presence of bleeding on probing, 4 sites per implant, Yes=1 or No=0