Prediction of Primary Implant Stability From Bone Quality Obtained Prior to Implant Placement Using CBCTCBCTNCT06654518
Prediction of Primary Dental Implant Stability Preoperatively Using CBCT of the Planned Implant Site.
A study testing Preoperative CBCT for Bone Density and Ridge Width Measurement in people with Prediction of Primary Implant Stability From Bone Quality Obtained Prior to Implant Placement Using CBCT, run by Soaad Tolba Mohammed Tolba Badawi at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Prediction of Primary Implant Stability From Bone Quality Obtained Prior to Implant Placement Using CBCT
- What is being tested?
- Preoperative CBCT for Bone Density and Ridge Width Measurement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2023to 1 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry, Mansoura University
Al Mansurah, Dakahlia Governorate, 35511
About this study
Official title: The Prognostic Accuracy of Bone Density and Alveolar Ridge Width Estimated by CBCT in Predicting Primary Implant Stability: Clinical Study.
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.
Read the detailed description
The quality and quantity of bone available for placing dental implants are key factors in the success of these implants. Implants placed in bone with insufficient quantity or poor quality have a higher risk of failure. As a result, evaluating the bone structure prior to implant placement surgery is essential for proper planning of the treatment.
- Being tested
- Preoperative CBCT for Bone Density and Ridge Width Measurement
- Keywords
- bone density, alveolar ridge width, insertion torque, resonance frequency analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative CBCT for Bone Density and Ridge Width MeasurementDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Preoperative CBCT for Bone Density and Ridge Width Measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured immediately after implant placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study start1 Feb 2023
- Primary completion1 Jun 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prediction of Primary Implant Stability From Bone Quality Obtained Prior to Implant Placement Using CBCTStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Soaad Tolba Mohammed Tolba Badawi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Soaad Tolba Mohammed Tolba Badawi, Mansoura University
- Investigators
- Soaad T Badawi, Lecturer, Oral Surgery, MU, Principal investigator, Faculty of dentistry, Mansoura university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06654518
- Sponsor's protocol ID
- A28030123
- Acronym
- CBCT
- Status last verified
- Oct 2024
- First submitted
- 21 Oct 2024
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: "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."
Publications
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.
PubMed 32221558
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prognostic Accuracy of Bone Density and Alveolar Ridge Width Estimated by CBCT in Predicting Primary Implant Stability: Clinical Study.
- ClinicalTrials.gov ID
- NCT06654518
- Acronym / sponsor ID
- CBCT / A28030123
- Keywords
- bone density, alveolar ridge width, insertion torque, resonance frequency analysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Soaad Tolba Mohammed Tolba BadawiUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 23 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The quality and quantity of bone available for placing dental implants are key factors in the success of these implants. Implants placed in bone with insufficient quantity or poor quality have a higher risk of failure. As a result, evaluating the bone structure prior to implant placement surgery is essential for proper planning of the treatment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| participants underwent preoperative CBCT measurements to guide the dental implant placement process. | Experimental | Diagnostic Test: Preoperative CBCT for Bone Density and Ridge Width MeasurementParticipants 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preoperative CBCT for Bone Density and Ridge Width MeasurementParticipants 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. | Diagnostic test | participants underwent preoperative CBCT measurements to guide the dental implant placement process. |
Primary outcome
Primary Implant Stability Using Resonance Frequency Analysis (RFA)and final insertion torque value (ITV)
Time frame: Measured immediately after implant placement
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Background: PubMed 32221558de 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.
- Individual participant dataSharing planned: No. "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."
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Soaad T Badawi, Lecturer, Oral Surgery, MU principal investigator
Faculty of dentistry, Mansoura university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative CBCT for Bone Density and Ridge Width Measurement in people with Prediction of Primary Implant Stability From Bone Quality Obtained Prior to Implant Placement Using CBCT, run by Soaad Tolba Mohammed Tolba Badawi at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Implant Stability Using Resonance Frequency Analysis (RFA)and final insertion torque value (ITV) (time frame: Measured immediately after implant placement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06654518, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.