Cone Beam Computed TomographyNCT03932357
Measuring Soft Tissue Thickness by CBCT
An observational study of Cone Beam Computed Tomography, run by Cairo University at 1 site in Egypt.
Trial summary
accuracy of CBCT in measuring soft tissue thickness by using a radiopaque material as the real finding and measurements on pig jaws Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cone Beam Computed Tomography
- What is being tested?
- CBCT
- Type of treatment
- Surgery or procedure
- How many people
- 15 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Apr 2019to 9 Dec 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: CBCT measuring soft tissue thickness using a radiopaque material
Who may be able to join
- The study samples will not identified by age or gender group.
- The selected pig jaw should be intact with no mechanical damage.
- jaw with attached natural teeth
Who cannot join
- Teeth with anomalies and fractures.
- Periodontally affected teeth
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Mahinaz Reda Hassan
Cairo, Giza-elharam, 11211
Mahinaz R Abdelhamed, master, 01005610622 ext. 02, dentist_m2012@hotmail.com
Mohamed A abas, master, 01004100946 ext. 02, dentist-86-2009@hotmail.com
About this study
Official title: Accuracy of Cone Beam Computed Tomography in Measuring of Mandibular Pig Soft Tissue Thickness Using a Radiopaque Material in Comparesion With Real Measurement.Diagnostic Study
accuracy of CBCT in measuring soft tissue thickness by using a radiopaque material as the real finding and measurements on pig jaws
Read the detailed description
- Pig jaws will be included in this study.
- Soft tissue surfaces were lightly covered with barium sulfate powder using a powder spray. CBCT was taken.
- A periodontal probe and a rubber stop were used for the measurement of trans-gingival probing thickness (TPT).
- After that, flap were elevated, and actual thickness of soft-tissue (actual thickness, AT) was measured.
The Analytical phase:
- In order to assess soft tissue thickness and bone levels an electronic digital caliper (Shenhan Measuring Tools Co., LTD, Shanghai) will used for measuring the transgingival probing thickness on the pig jaws.
- A graduated Naber's probe will be used for measuring the transgingival probing thickness.
Soft tissue thickness measurements:
- Intra-observer variability was tested under the supervision of the director.
- For the measurement of radiographic thickness (RT), wet soft tissue surfaces were covered with barium sulfate powder (SoloTop; Taejoon, Seoul, Korea), a radiopaque material used as a contrast medium.
- A probes and rubber stop were used for the measurement of transgingival probing thickness (TPT).
- A rubber stop was placed in contact with the surface to facilitate the measurement of tissue thickness, and then TPT was measured with digital calipers. All measurements were rounded to the nearest 0.01 mm.
- For the measurement of actual thickness (AT), an incision was made onto each marked area. After flap elevation, actual soft tissue thickness was measured using the same method that was used for TPT.
Radiographic examination
- The pig jaws will then be imaged with CBCT.
- CBCT scanning will be performed using a PROMAX R 3DMid CBCT device (Planmeca Oy, Helsinki, Finland) with scanning protocol 90 kVp, 8 mA and 13.58 seconds exposure time with a single 360 degree rotation ROMEXIS software. The jawes will be placed on the horizontal plate of the device. The midline and mandibular position will be adjusted using the laser guide
- Conditions
- Cone Beam Computed Tomography
- Being tested
- CBCT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBCTRadiation
measuring soft tissue thickness using a CBCT
What is being measured
The primary outcome is the main question the study is designed to answer.
cbct
measuring soft tissue thickness using cbct in pig jaw
Measured: 6 months
Secondary outcomes (1)
Acutal thickness measurement
periodontal probe was inserted vertically into the soft tissue surface until resistance of the bone was felt
. A rubber stop was placed in contact with the surface to facilitate the measurement of tissue thickness.actual thickness was measured with digital calipers
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2019
- Study start20 Apr 2019
- Primary completion30 Sep 2021 (estimated)
- Study completion9 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cone Beam Computed TomographyStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahinaz Reda Hassan Abdelhamed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03932357
- Sponsor's protocol ID
- Mahinaz Reda
- Status last verified
- Aug 2021
- First submitted
- 23 Apr 2019
- Last updated
- 20 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Cone Beam Computed Tomography in Measuring of Mandibular Pig Soft Tissue Thickness Using a Radiopaque Material in Comparesion With Real Measurement.Diagnostic Study
- ClinicalTrials.gov ID
- NCT03932357
- Acronym / sponsor ID
- Mahinaz Reda
- Conditions
- Cone Beam Computed Tomography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Apr 2019 (actual)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 9 Dec 2021 (estimated)
- First posted
- 30 Apr 2019 (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.
accuracy of CBCT in measuring soft tissue thickness by using a radiopaque material as the real finding and measurements on pig jaws
Detailed description
- Pig jaws will be included in this study.
- Soft tissue surfaces were lightly covered with barium sulfate powder using a powder spray. CBCT was taken.
- A periodontal probe and a rubber stop were used for the measurement of trans-gingival probing thickness (TPT).
- After that, flap were elevated, and actual thickness of soft-tissue (actual thickness, AT) was measured.
The Analytical phase:
- In order to assess soft tissue thickness and bone levels an electronic digital caliper (Shenhan Measuring Tools Co., LTD, Shanghai) will used for measuring the transgingival probing thickness on the pig jaws.
- A graduated Naber's probe will be used for measuring the transgingival probing thickness.
Soft tissue thickness measurements:
- Intra-observer variability was tested under the supervision of the director.
- For the measurement of radiographic thickness (RT), wet soft tissue surfaces were covered with barium sulfate powder (SoloTop; Taejoon, Seoul, Korea), a radiopaque material used as a contrast medium.
- A probes and rubber stop were used for the measurement of transgingival probing thickness (TPT).
- A rubber stop was placed in contact with the surface to facilitate the measurement of tissue thickness, and then TPT was measured with digital calipers. All measurements were rounded to the nearest 0.01 mm.
- For the measurement of actual thickness (AT), an incision was made onto each marked area. After flap elevation, actual soft tissue thickness was measured using the same method that was used for TPT.
Radiographic examination
- The pig jaws will then be imaged with CBCT.
- CBCT scanning will be performed using a PROMAX R 3DMid CBCT device (Planmeca Oy, Helsinki, Finland) with scanning protocol 90 kVp, 8 mA and 13.58 seconds exposure time with a single 360 degree rotation ROMEXIS software. The jawes will be placed on the horizontal plate of the device. The midline and mandibular position will be adjusted using the laser guide
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- CBCT measuring soft tissue thickness using a radiopaque material
Key inclusion criteria (3 listed)
- The study samples will not identified by age or gender group.
- The selected pig jaw should be intact with no mechanical damage.
- jaw with attached natural teeth
Key exclusion criteria (2 listed)
- Teeth with anomalies and fractures.
- Periodontally affected teeth
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 |
|---|---|---|
| CBCTmeasuring soft tissue thickness using a CBCT | Radiation | – |
Primary outcome
cbct
Time frame: 6 months
measuring soft tissue thickness using cbct in pig jaw
1 secondary outcome
Acutal thickness measurement
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2021.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cone Beam Computed Tomography, run by Cairo University 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 3 inclusion and 2 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 20 Aug 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact mahinaz R abdelhamed, master (01005610622 ext. 02, dentist_m2012@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cbct (time frame: 6 months). 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 20 Aug 2021.