Immediate Loading Of Dental Implants: A Pilot Clinical Study
1 other identifier
interventional
18
1 country
1
Brief Summary
Objective: To provide 2-year clinical- and patient-oriented data with regard to mandibular overdenture assisted by 2 immediately loaded unsplinted implants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2011
1 active site
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
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 16, 2012
CompletedFirst Posted
Study publicly available on registry
July 18, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedResults Posted
Study results publicly available
May 6, 2014
CompletedJune 2, 2017
May 1, 2017
1.8 years
July 16, 2012
August 26, 2013
May 1, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Patient Satisfaction With the Immediate Loading Protocol
Visual Analogue Scale (VAS) to assess patients' satisfaction, with a score of 100 being extremely satisfied (minimum and maximum scores: 1-100 respectively).
4 months
Oral-health-related Quality of Life With the Immediate Loading Protocol
Oral Health Impact Profile (OHIP-20) to assess oral-health-related quality of life: score ranges between 20 and 120 points, with a lower score indicating a better oral-health-related quality of life.
4 months
Study Arms (1)
Immediate loading
EXPERIMENTALImmediate loading of 2 endo-osseous mandibular implants
Interventions
Eligibility Criteria
You may qualify if:
- Minimal age of 18 years
- Complete edentulism for more than 1 year
- Wear of total conventional prosthesis for more than 1 year
- Bone morphology in the anterior mandibular region amendable for the placement of 3 regular diameter implants without any additional procedure (graft or membrane).
You may not qualify if:
- Any absolute or relative contra-indication to implant therapy
- Physical incapacity to render oral or prosthetic hygiene
- Incapacity to obtain a free and informed consent
- Incapacity to assist to planned follow up appointments
- Incapacity to understand and complete questionnaires
- Inadequate bone quality: IT\<35 Ncm
- Inadequate primary stability: ISQ\<60
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Université de Montréal
Montreal, Quebec, H3Y1P2, Canada
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Phase-I clinical trial with small sample size and a pre-post design with no control group.
Results Point of Contact
- Title
- Elham Emami, DDS, MSc, PhD
- Organization
- Université de Montréal
Study Officials
- PRINCIPAL INVESTIGATOR
Elham Emami, DDS, MSc,PhD
Université de Montréal, Faculty of Dentistry
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Masking Details
- Investigators were not involved in data analysis
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- D.D.S., M. Sc., Ph. D, Professor
Study Record Dates
First Submitted
July 16, 2012
First Posted
July 18, 2012
Study Start
June 1, 2011
Primary Completion
March 1, 2013
Study Completion
March 1, 2013
Last Updated
June 2, 2017
Results First Posted
May 6, 2014
Record last verified: 2017-05