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

Christian Makary1 site in 1 country18 target enrollmentJune 3, 2021

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 3, 2021

End Date

December 1, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

Christian Makary

Responsible Party

Sponsor Investigator

Principal Investigator

Christian Makary

Professor

Saint-Joseph University

•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;
•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

•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;