Soft Tissue Volume, Dimensions and Tomographic Alveolar R... | NCT06354374

Studies
Soft Tissue Volume, Dimensions and Tomographic Alveolar Ridge Classification System for Dental Implant Treatment.

NCT06354374

Sponsor

Ain Shams University

Status

Recruiting

Last Update Posted

Aug 6, 2024Actual

Enrollment

350Estimated

Phase

Not provided

Conditions

Soft Tissue Volume

Interventions

volume survey

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 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 22, 2024Actual

Primary Completion Date

Jul 2025Estimated

Completion Date

Dec 2025Estimated

First Submitted Date

Mar 31, 2024

First Submission Date that Met QC Criteria

Apr 5, 2024

First Posted Date

Apr 9, 2024Actual

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 4, 2024

Last Update Posted Date

Aug 6, 2024Actual

Name	Class
British University In Egypt	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Despite the importance of soft tissue dimensions for periodontal, restorative, implant, and orthodontic treatment, the current classifications of tomographic alveolar ridge topography lack the soft tissue component(Tolstunov, 2014). Therefore, the present study will be to evaluate the relationship between soft tissue volume and the dimensions & tomographic alveolar ridge classes as well as to incorporate the soft tissue volumetric evaluation in the classification system.

Detailed Description

Not provided

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

350Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
volume survey	Diagnostic Test	All subjects will receive oral hygiene instructions and, if needed. A dental cleaning of plaque and calculus. After calibration using digital photographs and digital intraoral scans, CBCT scans will be taken as a prerequisite for dental implant treatment protocol. one dentist who will not be involved in the screening phase will obtain all clinical parameters (gingival biotype, probing depth, gingival thickness, gingival width) to avoid any bias. After finishing data collection, a customized treatment plan for each patient will be performed and dental implant treatment will be completed for each patient.

Measure	Description	Time Frame
the relationship between soft tissue volume & tomographic alveolar ridge classes	the relationship between soft tissue volume and tomographic alveolar ridge classes	3 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult patients in a healthy systemic condition who required comprehensive dental treatment.
Both genders with age group > 18 years old.
Patients should have at least a single missing tooth that requires dental implant placement.
Healing period of 3 months after extraction prior to surgical procedures.
CBCT scans will be obtained as a part of the comprehensive dental treatment.
Patients should approve to deliver a signature to a written consent after studying nature explanation.

Exclusion Criteria:

Patients with severe smoking habits >10 cig \ day.
Pregnant females, decisional impaired individuals, Prisoners, and handicapped patients.
Patients having poor oral hygiene or not wanting to carry out oral hygiene measures.
Patients on any medication affecting the soft tissue health (e.g., amlodipine, Cyclosporine A, hydantoin)
Patients with infections either periodontally or periapically

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

This cross sectional observational clinical study will include 350 patients that will be recruited from the outpatient clinic of the department of Oral Medicine, Periodontology, and Diagnosis, Faculty of Dentistry, The British University in Egypt.

Demographic data of all patients will be collected. Patients will be clearly instructed about the purpose of this study and will give their consent by signing an informed consent.

The study will be started after being accepted by the faculty of Dentistry, The British University in Egypt Research Ethics Committee. The study tracks the guidelines of the research ethical committee in line with the Helsinki Declaration of 1975.

Sampling Method

Probability Sample