Clinical and Radiographic Assessment of a Novel Wedge Shape Implant Placed in Edentulous Narrow Ridges

Study Overview
=================
Brief Summary
-----------------
The aim is to clinically and radiographically assess a novel wedge implant placed in narrow ridges. 60 wedge implants (Rex Implants, Columbus, OH, USA) will be placed using Piezosurgery® following either a bone consumption (n=30) or bone expansion technique (n=30). Each group (bone consumption and bone expansion) will be divided into 2 surface treatments: machined transcortical portion (n=15) and roughened transcortical portion (n=15). Record the time needed to place each implant. ISQ will be evaluated at Day 0, 3 weeks, 6 weeks, 3 months, 4 months, and 6 months after implant placement. Periapical radiographs will be performed at implant placement, loading. and 1, 3, and 5 years after loading to assess marginal bone stability. Buccal bone height and lingual and buccal bone thickness will be recorded post-intervention, at the time of functional loading, and at 12, 36, and 60 months after loading with CBCT. Digital impressions will be taken post-operatively, at loading and at 12 months after loading to monitor gingival profile.

Official Title
-----------------
Clinical and Radiographic Assessment of a Novel Wedge Shape Implant Placed in Edentulous Narrow Ridges: Comparison of Bone Consuming and Bone Expanding Techniques for Implants Presenting Either Machined or Roughened Transcortical Portion

Conditions
-----------------
Surgical Technique, Implant Surface

Intervention / Treatment
-----------------
* Procedure: Bone Consumption
* Procedure: Bone expansion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Partially or totally edentulous patients presenting indications for a prosthetic rehabilitation supported by the upper or lower jaw implants on the basis of an accurate diagnosis and treatment planning; the bone crest must be completely healed (at least six months after the loss of teeth); the residual bone crest must have a width between 3 and 5 mm; presence of at least 10 mm of bone height available for implant placement; 5) patient age > 18 years; 6) the patient must not wear any type of removable dentures on the treated area; 7) the patient must be capable of following the study protocol; and 8) written informed consent must be provided Exclusion Criteria: acute myocardial infarction within the last two months; Uncontrolled coagulation disorders; uncontrolled diabetes (HBA1c> 7.5); radiation therapy to the head \ neck region in the last 24 months; immunocompromised patients, HIV positive or receiving chemotherapy in the last five years; past or present treatment with intravenous bisphosphonates; psychological or psychiatric problems; abuse of alcohol or drugs;

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 62 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rex implant machined transcortical portion<br>Implants in these group will have a machined portion at the neck of the implant | Procedure: Bone Consumption<br>* The surgery will be done using a bone consumption protocol<br>Procedure: Bone expansion<br>* implants will be placed after a bone expansion protocol<br>|
| Active Comparator: Rex implant roughened transcortical portion<br>Rex implants with a rough surface until the neck of the implant | Procedure: Bone Consumption<br>* The surgery will be done using a bone consumption protocol<br>Procedure: Bone expansion<br>* implants will be placed after a bone expansion protocol<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant stability | Implant stability quotient evaluation | 0, 3 weeks, 6 weeks, 3 months, 4 months, and 6 months after implant placement. | 
| Bone stability | Periapical radiograph and CBCT | At 6 months, and at 12, 36, and 60 months after loading | 
| Gingival profile monitoring | Digital impression superimposition | Day 0 of surgery, at 6 months and at 12 months. |