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

NCT06178536 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2023-12-21

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Christian Makary

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
62 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-06-03
Primary Completion
2023-12-01
Completion
2023-12-01

Countries

  • Lebanon

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06178536 on ClinicalTrials.gov