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OpenTrials
Completed

NCT Number: NCT01064843

Clinical Evaluation of the Mandibular Mini-Implant Overdenture

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.

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Key information

Conditions

Stabilization of a Full Lower Denture Edentulism in Lower Jaw Lower Denture Made Within Last Few Years Mouth Diseases Mouth, Edentulous Stomatognathic Diseases Tooth Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of Dentistry, McGill University

Montreal, Quebec, H3A 2A7, Canada

About this study

To test whether the percentage of case successes of these lower dentures supported by 4 MDIs is equal to or greater than 95% at 1 year. Success is defined as a denture supported by implants that is functioning in the way it was intended.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Imtec MDI

Device

4 Imtec MDI

Primary outcomes

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

    Time frame: 3 years

Secondary outcomes

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

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Solventum US LLC

Industry

Collaborators

  • 3M
  • McGill University

Registry information

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Feb 9, 2010
Registry last updated
Dec 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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