Clinical trial NCT04135222: Evaluation of Periodontal Phenotype Using CBCT, Computed Aided Design (CAD) and Prosthetic-driven Implant Planing (PDIP).
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Periodontal Diseases
Lead sponsor: Wroclaw Medical University
Sponsor class: OTHER
First posted: 2019-10-22
Enrollment: 30
Sex: ALL
Minimum age (years): 24
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: male 16 female 14

Brief summary: The use of CBCT/CAD 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 CW/CL 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 CW/CL, 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.

Eligibility criteria: Inclusion criteria:

* lack of general diseases
* good hygiene of oral cavity
* healthy periodontium - API ratio\<15%, BOP\<10%
* no loss of clinical attachment in the examined sites (CAL=0)
* no use of drugs that could influence the structure of the periodontal tissues
* no addictions, especially nicotinism
* no use of mobile prosthetic restorations and orthodontic appliances
* no contraindications for X-ray examinations

Exclusion criteria:

* general diseases
* bad hygiene of oral cavity
* non healthy periodontium - API ratio\>15%, BOP\>10%
* loss of clinical attachment in the examined sites (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

Primary outcomes:
measure: determination the gingival and the periodontal phenotype
timeFrame: October 2018 to July 2019
Secondary outcomes:
Other outcomes:
Locations:
city: Wrocław
country: Poland
facility: Wroclaw Medical University
Study officials:
affiliation: Medical Uniwersity Wroclaw
name: wojciech bednarz, prof
role: STUDY_DIRECTOR
References: