Immediate Loading Of Dental Implants: A Pilot Clinical Study

Satisfaction Clinical Trial

Official title:

Immediate Loading Of Dental Implants In Mandible Full-Arch: A Pilot Clinical Study On Patients Satisfaction, Quality Of Life And Implant Success

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01644058
• Other study ID #: UDEM-EE-2012b
• Status: Completed
• Phase: Phase 1
• First received: July 16, 2012
• Last updated: April 4, 2014
• Start date: June 2011
• Est. completion date: March 2013

Study information

• Verified date: April 2014
• Source: Université de Montréal
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

Patients will be satisfied with the immediate loading protocol of two implants joined to a complete mandibular overdenture.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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

Exclusion Criteria to Immediate Loading Protocol Found on One or Both of Un-splinted Implants During Surgery:

• Inadequate bone quality: IT<35 Ncm

• Inadequate primary stability: ISQ<60

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Satisfaction

Intervention

Procedure:
• Immediate loading

Locations

Country	Name	City	State
Canada	Université de Montréal	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Université de Montréal

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No