Measuring Soft Tissue Thickness by CBCT | NCT03932357

Studies
Measuring Soft Tissue Thickness by CBCT

NCT03932357

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Aug 20, 2021Actual

Enrollment

15Estimated

Phase

Not provided

Conditions

Cone Beam Computed Tomography

Interventions

CBCT

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 20, 2019Actual

Primary Completion Date

Sep 30, 2021Estimated

Completion Date

Dec 9, 2021Estimated

First Submitted Date

Apr 23, 2019

First Submission Date that Met QC Criteria

Apr 29, 2019

First Posted Date

Apr 30, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 16, 2021

Last Update Posted Date

Aug 20, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

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 UniversityPrincipal Investigator

Lead Sponsor

Cairo UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

15Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CBCT	Radiation	measuring soft tissue thickness using a CBCT

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

CBCT measuring soft tissue thickness using a radiopaque material

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
mahinaz R abdelhamed, master	Contact	01005610622	02	dentist_m2012@hotmail.com
mohamed A abas, master	Contact	01004100946	02	dentist-86-2009@hotmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mahinaz Reda Hassan	Recruiting	Cairo	Giza-elharam	11211	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided