Immediate Loading Of Dental Implants: A Pilot Clinical Study

Not Applicable

Completed

• Conditions: Dental Implantation
• Interventions: Procedure: Immediate loading

• Registration Number: NCT01644058
• Lead Sponsor: Université de Montréal

Brief Summary

Objective: To provide 2-year clinical- and patient-oriented data with regard to mandibular overdenture assisted by 2 immediately loaded unsplinted implants.

Detailed Description

In this pre-post design, Phase-I clinical trial, 18 edentate individuals received a new set of complete denture. Then, following standard procedures, 3 threaded implants (OsseoSpeed TXTM, Dentsply Implants, Mölndal, Sweden) were placed in the mandible in each patient, and locator abutments (Zest Anchors LLC, Escondido, U.S.A.) were inserted on the right and left side implants. The midline implant served as a control for within-patient comparison. The immediate loading was conducted within 24 h of surgery. Data were collected at baseline (T0), 12 (T1) and 24 (T2) months after immediate loading. The clinical outcomes included implant survival rate, crestal bone level changes and implant stability. These criteria were assessed through clinical and radiographic examinations as well as resonance frequency analysis. Patient-centered outcomes included patient satisfaction and oral health-related quality of life measured using validated questionnaires. Brunner-Langer approach was used for statistical analysis.

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2012-07-16
• Study First Submitted QC: 2012-07-17
• Study First Posted: 2012-07-18
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Results First Submitted: 2013-08-26
• Results First Submitted QC: 2014-04-04
• Results First Posted: 2014-05-06
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-01
• Last Update Posted: 2017-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Immediate loading	Immediate loading	Immediate loading of 2 endo-osseous mandibular implants

Primary Outcome Measures

Name	Time	Method
Patient Satisfaction With the Immediate Loading Protocol	4 months	Visual Analogue Scale (VAS) to assess patients' satisfaction, with a score of 100 being extremely satisfied (minimum and maximum scores: 1-100 respectively).
Oral-health-related Quality of Life With the Immediate Loading Protocol	4 months	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.

Trial Locations

Locations (1)

Université de Montréal; 🇨🇦 Montreal, Quebec, Canada