Dental ImplantationNCT03164759
Correlation Between Radiographic Bone Density in CBCT and Implant Stability Quotient Value: Clinical Observational Study
An observational study of Dental Implantation, run by Cairo University.
Trial summary
Correlate the implant stability quotient values measured by ostell device with radiographic bone density measured on CBCT by bluesky software pre-operatively Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Implantation
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2017to 1 Jun 2018
- Phase
- Observational
- 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 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients receiving dental implants in healed non grafted sites in both arches
Who may be able to join
- patients receiving dental implants in both arches
- patients should be free from any systemic diseases that may affect normal healing of bone, and predicated outcome
- no intra-oral soft tissue defect that would render primary closure of the intra-oral wound
Who cannot join
- patients with systemic diseases
- patients with ridge augmentation such as ridge expansion, ridge splitting and bone grafting
- patients with sinus lifting done to place implants
- immediate extraction sockets
Trial locations and contacts
No sites are listed yet.
About this study
Correlate the implant stability quotient values measured by ostell device with radiographic bone density measured on CBCT by bluesky software pre-operatively
Read the detailed description
Dental implants have been widely used in the field of dental rehabilitation. Nowadays implant sucess rate is very high but to keep faliure rate as low as possible patient selection is very important especially regarding bone density to achieve high primary stability. Primary stability plays an important role in successful osteointegration of dental implants. This study was done to correlate between the bone density pre operatively measured on CBCT represented by HF unit and implant stability measured post operatively by ostell device represented by ISQ unit
- Conditions
- Dental Implantation
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone density
Measuring bone density on CBCT by bluesky software representing by hounsfield unit pre operatively
Measured: Baseline
Implant stability
Post oprative measurements of implant stability by ostell device (ISQ)
Measured: Immediate post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2017
- Study start1 Jun 2017 (estimated)
- Primary completion1 Jun 2018 (estimated)
- Study completion1 Jun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ImplantationStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Basyoni Mohammed Abo El Azem, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03164759
- Sponsor's protocol ID
- CEBC-CU-2017-05-23
- Status last verified
- May 2017
- First submitted
- 22 May 2017
- Last updated
- 24 May 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Radiographic Bone Density in CBCT and Implant Stability Quotient Value: Clinical Observational Study
- ClinicalTrials.gov ID
- NCT03164759
- Acronym / sponsor ID
- CEBC-CU-2017-05-23
- Conditions
- Dental Implantation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jun 2017 (estimated)
- Primary completion
- 1 Jun 2018 (estimated)
- Study completion
- 1 Jun 2018 (estimated)
- First posted
- 24 May 2017 (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.
Correlate the implant stability quotient values measured by ostell device with radiographic bone density measured on CBCT by bluesky software pre-operatively
Detailed description
Dental implants have been widely used in the field of dental rehabilitation. Nowadays implant sucess rate is very high but to keep faliure rate as low as possible patient selection is very important especially regarding bone density to achieve high primary stability. Primary stability plays an important role in successful osteointegration of dental implants. This study was done to correlate between the bone density pre operatively measured on CBCT represented by HF unit and implant stability measured post operatively by ostell device represented by ISQ unit
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients receiving dental implants in healed non grafted sites in both arches
Key inclusion criteria (3 listed)
- patients receiving dental implants in both arches
- patients should be free from any systemic diseases that may affect normal healing of bone, and predicated outcome
- no intra-oral soft tissue defect that would render primary closure of the intra-oral wound
Key exclusion criteria (4 listed)
- patients with systemic diseases
- patients with ridge augmentation such as ridge expansion, ridge splitting and bone grafting
- patients with sinus lifting done to place implants
- immediate extraction sockets
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Bone density
Time frame: Baseline
Measuring bone density on CBCT by bluesky software representing by hounsfield unit pre operatively
Implant stability
Time frame: Immediate post operative
Post oprative measurements of implant stability by ostell device (ISQ)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2017.
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Lactoferrin Nanohydrogel for Soft And Hard Tissue Healing and Implant Stability in Immediate Implant Placement
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Implantation, run by Cairo University.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 24 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohammed B Mohammed, Master (00201223232606, Beso901@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone density (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 May 2017.