Dental Implant Supported Removable Dental Prostheses

NCT ID: NCT03041597

Last Updated: 2017-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-01

Study Completion Date

2015-12-31

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.

Detailed Description

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Conditions

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Implant Complication Prosthesis Survival

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Immediate loading

Group Type EXPERIMENTAL

placement of implants

Intervention Type PROCEDURE

surgical procedure and placement of implants

immediate loading

Intervention Type PROCEDURE

cone-anchored implant supported removable dental prostheses placement

Ankylos implant

Intervention Type DEVICE

delayed loading

Group Type ACTIVE_COMPARATOR

placement of implants

Intervention Type PROCEDURE

surgical procedure and placement of implants

conventional loading

Intervention Type PROCEDURE

cone-anchored implant supported removable dental prostheses placement in 3mo

Ankylos implant

Intervention Type DEVICE

Interventions

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placement of implants

surgical procedure and placement of implants

Intervention Type PROCEDURE

immediate loading

cone-anchored implant supported removable dental prostheses placement

Intervention Type PROCEDURE

conventional loading

cone-anchored implant supported removable dental prostheses placement in 3mo

Intervention Type PROCEDURE

Ankylos implant

Intervention Type DEVICE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dentsply Sirona Implants and Consumables

INDUSTRY

Sponsor Role collaborator

KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Lauren Bernard

Periodontist

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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B32220096198

Identifier Type: -

Identifier Source: org_study_id

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