Implant Primary Stability and Ridge Dimensional Changes Utilizing the Osseodensification Protocol

NCT05283928 | Completed Results FDA Device

• 1 other identifier: HSC-DB-21-0597
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

osseodensification; ridge expansion

Outcome Measures

Primary Outcomes (3)

• Change in Bone Ridge Width at Crest

  bone ridge width will be measured using a Caliper

  day of implant surgery

• Change in Bone Ridge Width at 5mm Apical From Crest

  bone ridge width will be measured using a Caliper

  day of implant surgery

• Change in Bone Ridge Width at 10mm Apical From Crest

  bone ridge width will be measured using a Caliper

  day of implant surgery

Secondary Outcomes (8)

• Primary Stability of the Implants as Measured by the Insertion Torque Values

  day of implant surgery

• Primary Stability of the Implants as Indicated by the Implant Stability Quotient (ISQ) as Measured by the Resonance Frequency Analysis Using the Ostell ISQ Meter Baseline(After Implant Placement)

  baseline(after implant placement)

• Primary Stability of the Implants as Indicated by the Implant Stability Quotient (ISQ) as Measured by the Resonance Frequency Analysis Using the Ostell ISQ Meter 3 Weeks After Implant Placement

  3 weeks after implant placement

• Primary Stability of the Implants as Indicated by the Implant Stability Quotient (ISQ) as Measured by the Resonance Frequency Analysis Using the Ostell ISQ Meter 6 Weeks After Implant Placement

  6 weeks after implant placement

• Primary Stability of the Implants as Indicated by the Implant Stability Quotient (ISQ) as Measured by the Resonance Frequency Analysis Using the Ostell ISQ Meter 12 Weeks After Implant Placement

  12 weeks after implant placement

Study Arms (2)

OsseoDensification (OD) protocol

EXPERIMENTAL

Device: OsseoDensification (OD) protocol

standard drilling (SD) protocol

ACTIVE COMPARATOR

Device: standard drilling (SD) protocol (NobelReplace® Conical)

Interventions

OsseoDensification (OD) protocol 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.

OsseoDensification (OD) protocol

standard drilling (SD) protocol (NobelReplace® Conical) 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.

standard drilling (SD) protocol

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77054, United States

Location

MeSH Terms

Interventions

Clinical Protocols

Intervention Hierarchy (Ancestors)

Therapeutics; Epidemiologic Study Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Popi Stylianou, DDS,MS
• Organization: The University of Texas Health Science Center at Houston

Popi.Stylianou@uth.tmc.edu

713-486-4048

Study Officials

• Popi Stylianou, DDS,MS

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Model Details: Each participant served as their own control. Each participant had at least 1 control implant and at least 1 test implant.

Study Record Dates

• First Submitted: March 8, 2022
• First Posted: March 17, 2022
• Study Start: August 1, 2022
• Primary Completion: November 16, 2023
• Study Completion: March 4, 2024
• Last Updated: November 29, 2024
• Results First Posted: November 29, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)