Viewing Study NCT04135222



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Last Modification Date: 2024-10-26 @ 1:20 PM
Study NCT ID: NCT04135222
Status: COMPLETED
Last Update Posted: 2019-10-22
First Post: 2019-09-19

Brief Title: Evaluation of Periodontal Phenotype Using CBCT Computed Aided Design CAD and Prosthetic-driven Implant Planing PDIP
Sponsor: Wroclaw Medical University
Organization: Wroclaw Medical University

Study Overview

Official Title: Evaluation of Periodontal Phenotype Using Cone Beam Computed Tomography CBCT Intraoral Scanning by Computed Aided Design CAD and Prosthetic-driven Implant Planing PDIP
Status: COMPLETED
Status Verified Date: 2019-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: CBCTCAD
Brief Summary: The use of CBCTCAD and PDIP technology makes it possible to determine the gingival and the periodontal phenotype and it can be useful in establishing treatment plan in which it is required to carry out radiological diagnostics Assessment of the periodontal and the gingival phenotype in a patient using the method based on CWCL ratio is unreliable Determining it for each dento-gingival unit is the appropriate method

Positive correlation between FGT WKT and AC-GM distance confirms the purpose of measuring these parameters for evaluation of the gingival phenotype and additional TLPAC2 for the periodontal phenotype
Detailed Description: The gingival phenotype - GP is defined as three-dimensional volume of the gingiva and is defined by 2 clinical parameters - gingival thickness GT measured in mm and width of keratinized tissue WKT0measured in mm Assessment of the gingival phenotype was performed with the use of visual methods using the method of gingival transparency while probing the gingival grooves with a periodontal probe on the basis of transparency of the free gingiva of the upper incisors the shape of the crowns the height of gingival papillae and the width of the gingiva and recently using the Colorvue Periodontal Probes The gingival phenotype may be determined more precisely by using biometry of width of keratinized tissue and gingival thickness During surgical procedures in which it is planned to form a full thickness flap GT can be measured in a direct way for example using an orthodontic caliper or a gauge for thickness of prosthetic crowns measurement Most often however it is advisable to determine the gingival or the periodontal phenotype before initiating dental treatment at its planning stage

GT assessment can be performed with the use of invasive methods with a needle an endodontic tool or a periodontal probe with the use of radiological methods - parallel profile radiographs and CBCT and non-invasive methods - using an ultrasonic device and the optical coherence tomography Measurements of keratinized tissue width are most often carried out using a periodontal probe calibrated every 1mm

Assessment of the phenotype is very important not only while planning dental treatment but also in prediction of its results A patient with healthy periodontium but thin phenotype found in a single or in multiple dental units can be protected from the occurrence of complications of orthodontic prosthetic or implant-prosthetic treatment Radiological images obtained by CT scans are increasingly often assessed while planning such treatment Scientists have begun to use the possibilities of 3D visualization for the assessment of the periodontal phenotype using the CBCT method

Assessment of the periodontal and the gingival phenotype in a patient using the method based on CWCL is unreliable The phenotype should be assessed for each dento-gingival unit

The presence of positive correlation between WKT FGT and AC-GM confirms the validity of determining these parameters in the assessment of the gingival phenotype and additionally TLPAC2 in determining the periodontal phenotype

Using the CBCT CAD PDIP technology allows for determination of the gingival and the periodontal phenotype and can be useful while planning implantological and orthodontic treatment in which conducting radiological diagnostics is required In each case of gingival and periodontal phenotype assessment clinical examination of a patient along with determination of PD CAL and WKT in the conditions of healthy periodontium should be carried out

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None