Dental Implant Supported Removable Dental Prostheses | NCT03041597

Studies
Dental Implant Supported Removable Dental Prostheses

NCT03041597

Sponsor

KU Leuven

Status

Completed

Last Update Posted

Feb 3, 2017Estimated

Enrollment

15Actual

Phase

Not Applicable

Conditions

Implant Complication
Prosthesis Survival

Interventions

placement of implants
immediate loading
conventional loading
Ankylos implant

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2009Actual

Primary Completion Date

Dec 31, 2013Actual

Completion Date

Dec 31, 2015Actual

First Submitted Date

Jan 26, 2017

First Submission Date that Met QC Criteria

Feb 1, 2017

First Posted Date

Feb 3, 2017Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 1, 2017

Last Update Posted Date

Feb 3, 2017Estimated

Name	Class
Dentsply Sirona Implants and Consumables	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Immediate loading	Experimental		Procedure: placement of implants Procedure: immediate loading Device: Ankylos implant
delayed loading	Active Comparator		Procedure: placement of implants Procedure: conventional loading Device: Ankylos implant

Interventions

Name	Type	Description	Arm Group Labels	Other Names
placement of implants	Procedure	surgical procedure and placement of implants	Immediate loading delayed loading

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011475	Prosthesis Failure

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D057893	Immediate Dental Implant Loading

Ancestor Terms

ID	Term
D003758	Dental Implantation, Endosseous
D003757	Dental Implantation
D013516	Oral Surgical Procedures, Preprosthetic
D019647	Oral Surgical Procedures

Browse Leaves

Not provided

Browse Branches

Not provided