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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/22/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/22/2021.

Measuring Soft Tissue Thickness by CBCT

Clinicaltrials.gov identifier NCT03932357

Recruitment Status Recruiting

First Posted April 30, 2019

Last update posted April 30, 2019

Study Description

Brief summary:

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

  • Condition or Disease:Cone Beam Computed Tomography
  • Intervention/Treatment: Radiation: CBCT
  • Phase: N/A
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
  • Study Type: Observational
  • Estimated Enrollment: 15 participants
  • Observational Model: Case-Only
  • Time Perspective: Cross-Sectional
  • Official Title: Diagnostic Accuracy of Cone Beam Computed Tomography in Measuring Soft Tissue Thickness Using a Radiopque Material :an in Viteo Study
  • Actual Study Start Date: April 2019
  • Estimated Primary Completion Date: December 2019
  • Estimated Study Completion Date: May 2020
Outcome Measures
  • Primary Outcome Measures: 1. cbct [ Time Frame: 6 months ]
    measuring soft tissue thickness using cbct in pig jaw
  • Secondary Outcome Measures: 1. Acutal thickness measurement [ Time Frame: 6 months ]
    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
Eligibility Criteria
  • Ages Eligible for Study: (Child, Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
  • Sampling Method: Probability Sample
  • Study Population: CBCT measuring soft tissue thickness using a radiopaque material
Criteria

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

Contacts and Locations
Contacts

Contact: mahinaz R abdelhamed, master 01005610622 ext 02 dentist_m2012@hotmail.com

Contact: mohamed A abas, master 01004100946 ext 02 dentist-86-2009@hotmail.com

Locations

Egypt, Giza-elharam
Mahinaz Reda Hassan
Cairo

Sponsors and Collaborators

Cairo University

More Information
  • Responsible Party: Cairo University
  • ClinicalTrials.gov Identifier: NCT03932357 History of Changes
  • Other Study ID Numbers: Mahinaz Reda
  • First Posted: April 30, 2019 Key Record Dates
  • Last Update Posted: April 30, 2019
  • Last Verified: April 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • 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.: Yes