NCT03041597

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2009

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2013

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2015

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 26, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 3, 2017

Completed
Last Updated

February 3, 2017

Status Verified

February 1, 2017

Enrollment Period

4.3 years

First QC Date

January 26, 2017

Last Update Submit

February 1, 2017

Conditions

Implant ComplicationProsthesis Survival

Outcome Measures

Primary Outcomes (1)

  • bone loss

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

    Difference between loading and Year two

Secondary Outcomes (3)

  • probing pocket depth

    Difference between loading and Year two

  • plaque

    Difference between loading and Year two

  • bleeding on probing

    Difference between loading and Year two

Study Arms (2)

Immediate loading

EXPERIMENTAL
Procedure: placement of implantsProcedure: immediate loadingDevice: Ankylos implant

delayed loading

ACTIVE COMPARATOR
Procedure: placement of implantsProcedure: conventional loadingDevice: Ankylos implant

Interventions

placement of implantsPROCEDURE

surgical procedure and placement of implants

Immediate loadingdelayed loading
immediate loadingPROCEDURE

cone-anchored implant supported removable dental prostheses placement

Immediate loading
conventional loadingPROCEDURE

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

delayed loading
Ankylos implantDEVICE
Immediate loadingdelayed loading

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Prosthesis Failure

Interventions

Immediate Dental Implant Loading

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dental Implantation, EndosseousDental ImplantationOral Surgical Procedures, PreprostheticOral Surgical ProceduresSurgical Procedures, OperativeProsthesis ImplantationDentistryProsthodontics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Periodontist

Study Record Dates

First Submitted

January 26, 2017

First Posted

February 3, 2017

Study Start

September 1, 2009

Primary Completion

December 31, 2013

Study Completion

December 31, 2015

Last Updated

February 3, 2017

Record last verified: 2017-02