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Measuring Soft Tissue Thickness by CBCT

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ClinicalTrials.gov Identifier: NCT03932357
Recruitment Status : Recruiting
First Posted : April 30, 2019
Last Update Posted : April 30, 2019
Sponsor:
Information provided by (Responsible Party):
Mahinaz Reda Hassan Abdelhamed, Cairo University

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 Intervention/treatment
Cone Beam Computed Tomography 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

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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 20, 2019
Estimated Primary Completion Date : December 16, 2019
Estimated Study Completion Date : May 9, 2020

Intervention Details:
  • Radiation: CBCT
    measuring soft tissue thickness using a CBCT


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




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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03932357


Contacts
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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
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Egypt
Mahinaz Reda Hassan Recruiting
Cairo, Giza-elharam, Egypt, 11211
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   
Sponsors and Collaborators
Cairo University

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Responsible Party: Mahinaz Reda Hassan Abdelhamed, main supervisor Dr. Hoda Abd El Kader Saleh Professor, .Co-supervisor Dr: Walaa Abdelaty Associate Professor, Investigator: DR. Mahinaz Reda Hassan Assistant lecturer ., 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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No