NCT06178536

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Christian Makary · Academic / Other
• Sex: All
• Age: 35 Years – 62 Years
• Healthy volunteers: Accepted

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.

Conditions

• Surgical Technique
• Implant Surface

Interventions

Type	Name	Description
PROCEDURE	Bone Consumption	The surgery will be done using a bone consumption protocol
PROCEDURE	Bone expansion	implants will be placed after a bone expansion protocol

Timeline

• Start date: 2021-06-03
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2023-12-21
• Last updated: 2023-12-21

Locations

1 site across 1 country: Lebanon