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Evaluation of Periodontal Phenotype Using CBCT, Computed Aided Design (CAD) and Prosthetic-driven Implant Planing (PDIP). ((CBCT)(CAD))

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ClinicalTrials.gov Identifier: NCT04135222
Recruitment Status : Completed
First Posted : October 22, 2019
Last Update Posted : October 22, 2019
Sponsor:
Information provided by (Responsible Party):
Wroclaw Medical University

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.


Condition or disease Intervention/treatment
Periodontal Diseases Diagnostic Test: Measurements of gingiva thickness

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.

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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Other
Time Perspective: Prospective
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)
Actual Study Start Date : October 11, 2018
Actual Primary Completion Date : May 13, 2019
Actual Study Completion Date : July 7, 2019

Intervention Details:
  • Diagnostic Test: Measurements of gingiva thickness
    Measurements were performed at upper canines and incisors in thirty periodontally healthy patients. The CBCT/CAD technology along with the PDIP software were used to measure crestal (CGT in mm ), supracrestal (SGT in mm) and free gingival thickness (FGT in mm ) as well as alveolar crest-gingival margin (AC-GM) and cemento-enamel junction (AC-CEJ) distance and the TLPAC localized 2, 4 and 8mm apically than the edge of the AC. Width of keratinized tissue (WKT) were measured using a periodontal probe. For each patient, the periodontal phenotype was evaluated on the basis of coronal width/length (CW/CL in percentages) ratio of both upper central incisors. For each tooth, the gingival phenotype was assessed on the basis of the GT measurement( in mm).


Primary Outcome Measures :
  1. determination the gingival and the periodontal phenotype [ Time Frame: October 2018 to July 2019 ]

    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 (mm), WKT(mm) and AC-GM (mm) distance confirms the purpose of measuring these parameters for evaluation of the gingival phenotype and additional TLPAC2 for the periodontal phenotype.




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Ages Eligible for Study:   24 Years to 54 Years   (Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   16 male 14 female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
male 16 female 14
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04135222


Locations
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Poland
Wroclaw Medical University
Wrocław, Poland, 52129
Sponsors and Collaborators
Wroclaw Medical University
Investigators
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Study Director: wojciech bednarz, prof Medical Uniwersity Wroclaw
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Responsible Party: Wroclaw Medical University
ClinicalTrials.gov Identifier: NCT04135222    
Other Study ID Numbers: kb245/2018
First Posted: October 22, 2019    Key Record Dates
Last Update Posted: October 22, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases