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NCT Number: NCT04845581

Comparison of the Effectiveness of the USG and CBCT Combined With Intraoral Scanning 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.

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Key information

Age range

24 year–54 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Wroclaw Medical University

Wroclaw, 52129, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diagnostic tests: Determination of the gingival phenotype, measure gingival thickness and width of keratinized tissue

Procedure

Gingival thickness was measured using UGTM method and CBCT/ CAD with PDIP technology at upper incisors and canines in three points localized midbucally : Free gingival thickness (FGT), supracrestal ( SGT) and crestal (CGT). Width of keratinized tissue was measured using periodontal probe calibrated for 1 mm. The gingival phenotype was determined by both methods according to the following criteria: GT ≤ 0,7 mm - thin gingival phenotype, GT > 0,7 mm ≤ 1,0 mm - medium gingival phenotype, GT > 1,0 mm - thick gingival phenotype. Toincrease the repeatability of the results, two researchers tested the same values twice on 2days interval between sessions.

Primary outcomes

  1. Determination the gingival phenotype

    Time frame: october 2018 to august 2019

    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.

Sponsors and collaborators

Lead sponsor

Wroclaw Medical University

Other

Registry information

Official study title

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.

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 15, 2021
Registry last updated
Apr 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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