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Implant Primary Stability and Ridge Dimensional Changes Utilizing the Osseodensification Protocol

NCT05283928 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2024-11-29

Study results available
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Summary

The purpose of this study is to compare ridge dimensional changes between densification and standard drilling protocols and to compare primary and secondary stability of implants placed by bone densification and standard drilling protocols

Conditions

  • Dental Implants

Interventions

DEVICE

OsseoDensification (OD) protocol

Osseodensification is a drilling process by which bone is being compacted and auto-grafted in an outwardly expanding direction from the osteotomy. When the osseodensification drills are being rotated in a reversed, non-cutting direction a strong and dense layer of bone is formed along the walls and base of the osteotomy.

DEVICE

standard drilling (SD) protocol (NobelReplace® Conical)

osteotomy preparation through bone excavation is necessary in implant site development for the placement of dental implants. The process involves a forward cutting process with removal of bone tissue creating appropriate size osteotomy for the dental implant.

Sponsors & Collaborators

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Popi Stylianou, DDS,MS · The University of Texas Health Science Center, Houston

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-08-01
Primary Completion
2023-11-16
Completion
2024-03-04
FDA Device
Yes

Countries

  • United States

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 NCT05283928 on ClinicalTrials.gov