NCT06654518

Brief Summary

This study aimed to assess whether preoperative characteristics of the implant site, such as bone density and alveolar ridge width, assessed using cone beam computed tomography (CBCT), are significantly associated with primary stability, as assessed by resonance frequency analysis (RFA) and final insertion torque value (ITV), and thereby investigate if it is feasible to predict primary stability preoperatively using this form of radiologic examination of the planned implant site. All patients underwent preoperative CBCT. The bone density and alveolar ridge width were assessed. The primary implant stability quotient (ISQ) values were assessed by a wireless magnetic-based Osstell ISQ RF Analyzer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 21, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 23, 2024

Completed
Last Updated

February 10, 2026

Status Verified

October 1, 2024

Enrollment Period

1.3 years

First QC Date

October 21, 2024

Last Update Submit

February 8, 2026

Conditions

Keywords

bone density, alveolar ridge width, insertion torque, resonance frequency analysis

Outcome Measures

Primary Outcomes (1)

  • Primary Implant Stability Using Resonance Frequency Analysis (RFA)and final insertion torque value (ITV)

    The primary outcome measure was the primary stability of the dental implants as determined by resonance frequency analysis (RFA) and final insertion torque value (ITV). The Implant Stability Quotient (ISQ) was measured immediately after the implant placement. ITV and ISQ values were corelated with the preoperative CBCT measurements of bone density and alveolar ridge width to evaluate the prognostic accuracy of CBCT in predicting primary implant stability.

    Measured immediately after implant placement

Study Arms (1)

participants underwent preoperative CBCT measurements to guide the dental implant placement process.

EXPERIMENTAL

Participants in this arm underwent preoperative Cone Beam Computed Tomography (CBCT) scans to assess bone density and alveolar ridge width. The data obtained from these scans was used to guide dental implant placement, with the primary goal of predicting the primary stability of the implant. The intervention involved using CBCT technology to gather precise anatomical details that help optimize implant placement and ensure adequate bone support for the implant.

Diagnostic Test: Preoperative CBCT for Bone Density and Ridge Width Measurement

Interventions

Participants in this arm underwent preoperative Cone Beam Computed Tomography (CBCT) scanning to evaluate bone density and alveolar ridge width. The CBCT scans provide high-resolution, 3D images, which was used to guide the planning and placement of dental implants. The primary goal of the intervention was to assess how well the measurements obtained from CBCT could predict the primary stability of the implants postoperatively.

participants underwent preoperative CBCT measurements to guide the dental implant placement process.

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must be free from any systemic conditions that would contraindicate dental implant surgery.
  • Good oral hygiene.
  • Age above 18 years.
  • The planned implant site must have sufficient alveolar bone volume.

You may not qualify if:

  • Patients who have undergone radiation therapy to the head and neck region within the last 12 months.
  • Uncontrolled diabetes.
  • Patients who underwent dental extractions or bone augmentation at the planned implant site during the last six months in order to guarantee uniform bone maturation.
  • Severe clenching or bruxism is present.
  • Acute infection at the planned implant site.
  • Implant sites requiring a procedure for bone gain.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Mansoura University

Al Mansurah, Dakahlia Governorate, 35511, Egypt

Location

Related Publications (1)

  • de Elio Oliveros J, Del Canto Diaz A, Del Canto Diaz M, Orea CJ, Del Canto Pingarron M, Calvo JS. Alveolar Bone Density and Width Affect Primary Implant Stability. J Oral Implantol. 2020 Aug 1;46(4):389-395. doi: 10.1563/aaid-joi-D-19-00028.

    PMID: 32221558BACKGROUND

MeSH Terms

Interventions

Bone Density

Intervention Hierarchy (Ancestors)

Musculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Soaad T Badawi, Lecturer, Oral Surgery, MU

    Faculty of dentistry, Mansoura university

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
lecturer of oral and maxillofacial surgery department, Faculty of dentistry, Mansoura university, Egypt.

Study Record Dates

First Submitted

October 21, 2024

First Posted

October 23, 2024

Study Start

February 1, 2023

Primary Completion

June 1, 2024

Study Completion

August 1, 2024

Last Updated

February 10, 2026

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

"Individual Participant Data (IPD) from this study will not be shared due to privacy and confidentiality concerns, as well as institutional policies that restrict the sharing of sensitive personal data. The data collected includes health-related information that must be protected according to ethical guidelines and local regulations."

Locations