NCT01064843

Brief Summary

Stabilization of existing full lower dentures by means of mini-dental implants (MDI). To test whether 4 mini-implants placed at the front of the lower jaw can stabilize an immediately-modified existing lower denture.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

February 5, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 9, 2010

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

December 2, 2024

Status Verified

November 1, 2024

Enrollment Period

4.1 years

First QC Date

February 5, 2010

Last Update Submit

November 27, 2024

Conditions

Stabilization of a Full Lower DentureEdentulism in Lower JawLower Denture Made Within Last Few Years

Keywords

EdentulousEdentulismLower dentureMini dental implantImtec MDIDenture stabilizationCase success rate of overdentures stabilized by MDIGeneral satisfaction of patients with this treatmentOral health-related quality of life of these patientsCost estimates

Outcome Measures

Primary Outcomes (1)

  • Success rate of mandibular overdentures supported by 4 MDIs placed in the interforaminal region in the long term.

    3 years

Secondary Outcomes (1)

  • Oral health-related quality of life and general satisfaction of patients.

    3 years

Study Arms (1)

4 Imtec mini-dental implants (MDI)

4 Imtec MDI

Device: Imtec MDI

Interventions

Imtec MDIDEVICE

4 Imtec MDI

4 Imtec mini-dental implants (MDI)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Dental implant

You may qualify if:

  • Completely edentulous with last tooth extraction 2 years ago or longer.
  • Patients requesting implant stabilization of existing lower conventional denture.
  • Adequate space in anterior mandible for placement of 4 MDI implants.
  • Able to maintain adequate oral hygiene and keep dentures clean.
  • Healthy enough to have minor surgical procedures.
  • Have adequate understanding of written and spoken English or French.
  • Capable of providing written informed consent.

You may not qualify if:

  • Not enough room in mandibular bone for implant height.
  • Has acute or chronic symptoms of parafunctional disorders.
  • History of radiotherapy to orofacial region.
  • Are or have been taking bisphosphonate IV or other medications (to be evaluated by the researcher).
  • Health conditions that may jeopardize treatment (to be evaluated by the researcher).
  • Unable or unwilling to return for evaluations or study recalls.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, McGill University

Montreal, Quebec, H3A 2A7, Canada

Location

MeSH Terms

Conditions

Mouth, Edentulous

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesTooth Diseases

Study Officials

  • Jocelyne Feine, DDS, MSc, HDR

    Professor, Principal Investigator

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2010

First Posted

February 9, 2010

Study Start

February 1, 2010

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

December 2, 2024

Record last verified: 2024-11

Locations

CA(1)