Measuring Soft Tissue Thickness by CBCT

Cone Beam Computed Tomography Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03932357
• Other study ID #: Mahinaz Reda
• Status: Recruiting
• Start date: April 20, 2019
• Est. completion date: December 9, 2021

Study information

• Verified date: August 2021
• Source: Cairo University
• Contact: mahinaz R abdelhamed, master
• Phone: 01005610622
• Email: dentist_m2012[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

accuracy of CBCT in measuring soft tissue thickness by using a radiopaque material as the real finding and measurements on pig jaws

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: December 9, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Teeth with anomalies and fractures.

• Periodontally affected teeth

Related Conditions & MeSH terms

• Cone Beam Computed Tomography

Intervention

Radiation:
• CBCT
measuring soft tissue thickness using a CBCT

Locations

Country	Name	City	State
Egypt	Mahinaz Reda Hassan	Cairo	Giza-elharam

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cbct	measuring soft tissue thickness using cbct in pig jaw	6 months
Secondary	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	6 months