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Dental Implant Supported Removable Dental Prostheses

Primary Purpose

Implant Complication, Prosthesis Survival

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

placement of implants

immediate loading

conventional loading

Ankylos implant

About this trial

This is an interventional treatment trial for Implant Complication

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Immediate loading

delayed loading

Arm Description

Outcomes

Primary Outcome Measures

bone loss

measured in mm op peri-apical radiography. Mesial and Distal measurement of implant.

Secondary Outcome Measures

probing pocket depth

Measurement in mm, 4 sites per implant.

plaque

presence of plaque, 4 sites per implant, Yes=1 or No=0

bleeding on probing

presence of bleeding on probing, 4 sites per implant, Yes=1 or No=0

Full Information

NCT ID

NCT03041597

First Posted

January 26, 2017

Last Updated

February 1, 2017

Sponsor

KU Leuven

Collaborators

Dentsply Sirona Implants and Consumables

1. Study Identification

Unique Protocol Identification Number

NCT03041597

Brief Title

Dental Implant Supported Removable Dental Prostheses

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Completed

Study Start Date

September 1, 2009 (Actual)

Primary Completion Date

December 31, 2013 (Actual)

Study Completion Date

December 31, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

KU Leuven

Collaborators

Dentsply Sirona Implants and Consumables

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Implant Complication, Prosthesis Survival

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Immediate loading

Arm Type

Experimental

Arm Title

delayed loading

Arm Type

Active Comparator

Intervention Type

Procedure

Intervention Name(s)

placement of implants

Intervention Description

surgical procedure and placement of implants

Intervention Type

Procedure

Intervention Name(s)

immediate loading

Intervention Description

cone-anchored implant supported removable dental prostheses placement

Intervention Type

Procedure

Intervention Name(s)

conventional loading

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Ankylos implant

Primary Outcome Measure Information:

Title

bone loss

Description

measured in mm op peri-apical radiography. Mesial and Distal measurement of implant.

Time Frame

Difference between loading and Year two

Secondary Outcome Measure Information:

Title

probing pocket depth

Description

Measurement in mm, 4 sites per implant.

Time Frame

Difference between loading and Year two

Title

plaque

Description

presence of plaque, 4 sites per implant, Yes=1 or No=0

Time Frame

Difference between loading and Year two

Title

bleeding on probing

Description

presence of bleeding on probing, 4 sites per implant, Yes=1 or No=0

Time Frame

Difference between loading and Year two

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

Dental Implant Supported Removable Dental Prostheses

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