Immediate Loading Of Dental Implants: A Pilot Clinical Study

Study Overview
=================
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.

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

Conditions
-----------------
Dental Implantation

Intervention / Treatment
-----------------
* Procedure: Immediate loading


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate loading<br>Immediate loading of 2 endo-osseous mandibular implants | Procedure: Immediate loading<br> <br> * Other names: Procedure: Immediate loading of 2 endo-osseous unsplinted implants of a mandibular overdenture;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
immediate-loading, patient-based outcomes