Measuring Soft Tissue Thickness by CBCT

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

Study Overview

• Status: Recruiting
• Conditions: Cone Beam Computed Tomography
• Intervention / Treatment: Radiation: CBCT

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 Type: Observational
• Enrollment (Anticipated): 15

Contacts and Locations

• Study Contact: Name: Mahinaz R Abdelhamed, master; Phone Number: 02 01005610622; Email: dentist_m2012@hotmail.com
• Study Contact Backup: Name: Mohamed A abas, master; Phone Number: 02 01004100946; Email: dentist-86-2009@hotmail.com

Study Locations

• Egypt
  • Giza-elharam
    • Cairo, Giza-elharam, Egypt, 11211
      • Recruiting
      • Mahinaz Reda Hassan
      • Contact: Mahinaz R Abdelhamed, master; Phone Number: 02 01005610622; Email: dentist_m2012@hotmail.com
      • Contact: Mohamed A abas, master; Phone Number: 02 01004100946; Email: dentist-86-2009@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

CBCT measuring soft tissue thickness using a radiopaque material

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cbct	measuring soft tissue thickness using cbct in pig jaw	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2019
• Primary Completion (Anticipated): September 30, 2021
• Study Completion (Anticipated): December 9, 2021

Study Registration Dates

• First Submitted: April 23, 2019
• First Submitted That Met QC Criteria: April 29, 2019
• First Posted (Actual): April 30, 2019

Study Record Updates

• Last Update Posted (Actual): August 20, 2021
• Last Update Submitted That Met QC Criteria: August 16, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: Mahinaz Reda

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No