Comparison of the Effectiveness of the USG and CBCT Combined With Intraoral Scanning Determing the Gingival Phenotype in the Healthy Periodontium

Comparison of the Effectiveness of the Ultrasonic Method and Cone-beam Computed Tomography Combined With Intraoral Scanning and Prosthetic-driven Implant Planning Method in Determing the Gingival Phenotype in the Healthy Periodontium.

Compare two diagnostic methods: UGTM and CBCT/CAD/PDIP in determing the gingival phenotype in group of 30 periodontally healthy patients. Both methods were useful to establishing the gingival phenotype, however, ultrasonic method was more precisely for measurement of gingival thickness. There was positive correlation between the mean values of SGT and WKT and this indicates the need to measure these parameters in order to determine gingival phenotype.

Study Overview

• Status: Completed
• Conditions: Periodontal Diseases
• Intervention / Treatment: Procedure: Diagnostic tests: Determination of the gingival phenotype, measure gingival thickness and width of keratinized tissue

Detailed Description

Gingival phenotype (GP) should be determine in each dento-gingival unit as a 3D volume of gingiva with the following parameters: width of keratinized tissue (WKT) and gingival thickness (GT). The phenotype determination is extremely important during many dental procedures, such as in dental surgery, orthodontics, prosthetics or implantology because it allows to dental treatment planning and reduce the risk of complications. Previous methods of determining the gingival phenotype were based on the shape of the crowns of the upper incisors and transparency of the free gingiva. These methods are non-invasive, but innacurate. The gingival phenotype may be determined more precisely by using biometry of WKT and GT. There are several possible methods to measure the thickness of the gingiva, such as bone sounding, cone beam comuted tomography (CBCT) measurement or parallel profile radiographs, CBCT/CAD (CBCT and computer-aided design) and ultrasound method. The ultrasonic gingival tissue measurement (UGTM) method is non-invasive, removes the need for anesthesia, which may increases the volume of tissues, but requires the experience of the researcher. However, it is considered as effective and reproducible method of the measurement soft tissue thickness. CBCT/CAD/PDIP (CBCT/CAD and prosthetic-driven implant planning) method also can be used to establishing the gingival phenotype.

Measurements of WKT are most often carried out using a periodontal probe calibrated every 1mm. In each case, a necessary condition for the proper examination of the patient and determination of GP is healthy periodontium.

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Poland
  • Wrocław, Poland, 52129
    • Wroclaw Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 24 years to 54 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

male 16 female 14

Description

Inclusion Criteria:

• lack of general diseases
• good oral hygiene
• healthy periodontium - API ratio<15%, BOP<10%
• no loss of clinical attachment in the examined areas (CAL=0)
• no use of drugs
• no addictions, especially cigarette smoking
• no use of mobile prosthetic restorations and orthodontic appliances
• no contraindications for X-ray examinations

Exclusion Criteria:

• general diseases
• poor oral hygiene
• non healthy periodontium - API ratio>15%, BOP>10%
• loss of clinical attachment in the examined areas (CAL>1)
• use of drugs that could influence the structure of the periodontal tissues
• addictions, especially nicotinism
• use of mobile prosthetic restorations and orthodontic appliances
• contraindications for X-ray examinations

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determination the gingival phenotype	The UGTM and CBCT/CAD/PDIP methods are useful to determining of gingival phenotype but more accurate and repeatability is UGTM. The presence of a positive correlation between SGT and WKT indicates the need to measured these parameters for the evaluation of GP. T. It is very important to determine the gingival phenotype for each dento-gingival unit especially before complicated dental treatment.	october 2018 to august 2019

Collaborators and Investigators

• Sponsor: Wroclaw Medical University
• Investigators: Study Director: wojciech bednarz, prof, Wroclaw Medical Univeristy

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2018
• Primary Completion (Actual): July 20, 2019
• Study Completion (Actual): August 2, 2019

Study Registration Dates

• First Submitted: March 22, 2021
• First Submitted That Met QC Criteria: April 13, 2021
• First Posted (Actual): April 15, 2021

Study Record Updates

• Last Update Posted (Actual): April 15, 2021
• Last Update Submitted That Met QC Criteria: April 13, 2021
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Periodontal Diseases
• Other Study ID Numbers: kb245/2018(2)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No