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Completed

NCT Number: NCT05283928

Implant Primary Stability and Ridge Dimensional Changes Utilizing the Osseodensification Protocol

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

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Key information

Conditions

Dental Implants

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77054, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in Bone Ridge Width at Crest

    Time frame: day of implant surgery

    bone ridge width will be measured using a Caliper

  2. Change in Bone Ridge Width at 5mm Apical From Crest

    Time frame: day of implant surgery

    bone ridge width will be measured using a Caliper

  3. Change in Bone Ridge Width at 10mm Apical From Crest

    Time frame: day of implant surgery

    bone ridge width will be measured using a Caliper

Secondary outcomes

  1. Primary Stability of the Implants as Measured by the Insertion Torque Values

    Time frame: day of implant surgery

    Insertion torque refers to the force used to insert an implant into bone, and it is reported in units of Newton-Centimeters (N-cms).

  2. 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)

    Time frame: baseline(after implant placement)

    The Implant Stability Quotient (ISQ) value is a measurement used to assess the stability of dental implants. It is obtained by resonance frequency analysis and ranges from 1 to 100, with higher values indicating greater stability.

  3. 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

    Time frame: 3 weeks after implant placement

    The Implant Stability Quotient (ISQ) value is a measurement used to assess the stability of dental implants. It is obtained by resonance frequency analysis and ranges from 1 to 100, with higher values indicating greater stability.

  4. 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

    Time frame: 6 weeks after implant placement

    The Implant Stability Quotient (ISQ) value is a measurement used to assess the stability of dental implants. It is obtained by resonance frequency analysis and ranges from 1 to 100, with higher values indicating greater stability.

  5. 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

    Time frame: 12 weeks after implant placement

    The Implant Stability Quotient (ISQ) value is a measurement used to assess the stability of dental implants. It is obtained by resonance frequency analysis and ranges from 1 to 100, with higher values indicating greater stability.

  6. Volume of the Ridge as Assessed by the Cone Beam Computer Tomography (CBCT)

    Time frame: 6 months post implantation

  7. Percent Change of Buccal Bone Thickness as Assessed by the Cone Beam Computer Tomography at 1.5 mm From the Implant Platform

    Time frame: 6 months post implantation

    The buccal bone thickness (BBT) was measured using cone beam computed tomography (CBCT). The percentage change in BBT was calculated by comparing the post-implant measurements to baseline values, with positive percentages indicating an increase in thickness and negative percentages indicating a decrease in thickness.

  8. Percent Change of Buccal Bone Thickness as Assessed by the Cone Beam Computer Tomography at 5 mm From the Implant Platform

    Time frame: 6 months post implantation

    The buccal bone thickness (BBT) was measured using cone beam computed tomography (CBCT). The percentage change in BBT was calculated by comparing the post-implant measurements to baseline values, with positive percentages indicating an increase in thickness and negative percentages indicating a decrease in thickness.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Mar 17, 2022
Registry last updated
Nov 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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