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CompletedNCT04845581Updated Apr 15, 2021

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

An observational study in Periodontal Diseases, sponsored by Wroclaw Medical University. Completed at 1 site in Poland. Open to participants aged 24 Years to 54 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-04-15.

Sponsored by Wroclaw Medical University · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
30
Ages
24 Years to 54 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Periodontal Diseases

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03

In context

Periodontal Diseases

830 studies on the registry are indexed under Periodontal Diseases; 188 are open to participants now.

This study's enrollment of 30 is below the median of 100 across 291 observational studies indexed under Periodontal Diseases.

Browse Periodontal Diseases studies →

Lead sponsor

Wroclaw Medical University is the lead sponsor of 93 studies on the registry; 28 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
24 Years to 54 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

male 16 female 14

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

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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
30 participants (actual)
Patient registry
No

Interventions

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

    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 \&gt; 0,7 mm ≤ 1,0 mm - medium gingival phenotype, GT \&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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: october 2018 to august 2019

07

Study locations

1 site
  • Wroclaw Medical University
    Wrocław, 52129, Poland
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 15, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04845581
Lead sponsor
Wroclaw Medical University
Responsible party
Sponsor
First posted
Apr 15, 2021
Start date
Oct 11, 2018
Primary completion
Jul 20, 2019
Completion
Aug 2, 2019
Last update
Apr 15, 2021

Study contacts

wojciech bednarz, prof
study director · wroclaw medical univeristy

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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