Clinical Evaluation of the Mandibular Mini-Implant Overdenture
This study has been completed.
Information provided by (Responsible Party):
First received: February 5, 2010
Last updated: May 29, 2014
Last verified: May 2014
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.
Stabilization of a Full Lower Denture
Edentulism in Lower Jaw
Lower Denture Made Within Last Few Years
Device: Imtec MDI
||Time Perspective: Prospective
||Clinical Evaluation of the Mandibular Mini-Implant Overdenture
Primary Outcome Measures:
- Success rate of mandibular overdentures supported by 4 MDIs placed in the interforaminal region in the long term. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Oral health-related quality of life and general satisfaction of patients. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||March 2014 (Final data collection date for primary outcome measure)
4 Imtec mini-dental implants (MDI)
4 Imtec MDI
Device: Imtec MDI
4 Imtec MDI
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.
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01064843
|Faculty of Dentistry, McGill University
|Montreal, Quebec, Canada, H3A 2A7 |
||Jocelyne Feine, DDS, MSc, HDR
||Professor, Principal Investigator
No publications provided
History of Changes
|Other Study ID Numbers:
||3M ESPE CR-09-020
|Study First Received:
||February 5, 2010
||May 29, 2014
||Canada: Health Canada
Keywords provided by 3M:
ClinicalTrials.gov processed this record on March 26, 2015
Mini dental implant
Case success rate of overdentures stabilized by MDI
General satisfaction of patients with this treatment
Oral health-related quality of life of these patients