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Implant Primary Stability and Ridge Dimensional Changes Utilizing the Osseodensification Protocol

NCT ID: NCT05283928

Last Updated: 2024-11-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-01

Study Completion Date

2024-03-04

Brief Summary

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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

Detailed Description

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Conditions

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Dental Implants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Each participant served as their own control. Each participant had at least 1 control implant and at least 1 test implant.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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OsseoDensification (OD) protocol

Group Type EXPERIMENTAL

OsseoDensification (OD) protocol

Intervention Type DEVICE

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.

standard drilling (SD) protocol

Group Type ACTIVE_COMPARATOR

standard drilling (SD) protocol (NobelReplace® Conical)

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients who understand and agree to this study.
* Adequate Oral hygiene
* One or more edentulous spaces, which are 10 weeks or longer after extractions

Exclusion Criteria

* Pregnancy.
* Smoking of more than 5 cigarettes/day.
* History of alcoholism or drug abuse during the last 5 years.
* Uncontrolled Hypertension or diabetes.
* Patient with malignant tumor.
* Patients on daily dose of steroids.
* Patients with history of chemotherapy or radiation for the last 12 months.
Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Popi Stylianou

Clinical Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Popi Stylianou, DDS,MS

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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HSC-DB-21-0597

Identifier Type: -

Identifier Source: org_study_id