Clinical trial NCT04845581: Comparison of the Effectiveness of the USG and CBCT Combined With Intraoral Scanning Determing the Gingival Phenotype in the Healthy Periodontium
Official 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Periodontal Diseases
Lead sponsor: Wroclaw Medical University
Sponsor class: OTHER
First posted: 2021-04-15
Enrollment: 30
Sex: ALL
Minimum age (years): 24
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: male 16 female 14

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* lack of general diseases
* good oral hygiene
* healthy periodontium - API ratio\&lt;15%, BOP\&lt;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\&gt;15%, BOP\&gt;10%
* loss of clinical attachment in the examined areas (CAL\&gt;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

Primary outcomes:
measure: Determination the gingival phenotype
timeFrame: october 2018 to august 2019
Secondary outcomes:
Other outcomes:
Locations:
city: Wrocław
country: Poland
facility: Wroclaw Medical University
Study officials:
affiliation: wroclaw medical univeristy
name: wojciech bednarz, prof
role: STUDY_DIRECTOR
References: