AzTrials
AzTrials

Periodontal Diseases(CBCT)(CAD)NCT04135222

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

An observational study of Periodontal Diseases, run by Wroclaw Medical University at 1 site in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 24 to 54 yearsHealthy volunteers can take part
Conditions the study is for
Periodontal Diseases
What is being tested?
Measurements of gingiva thickness
How many people
30 participants
Where
1 sitePoland
Study dates
11 Oct 2018to 7 Jul 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 24 to 54 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Study population: male 16 female 14

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Poland1 site
  • Wroclaw Medical University

    Wroclaw, 52129

Other trials in Poland

About this study

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)

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.

Read the 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.

Being tested
Measurements of gingiva thickness
Medical subject headings
Periodontal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Measurements of gingiva thicknessDiagnostic test

    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).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. determination the gingival and the periodontal phenotype

    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.

    Measured: October 2018 to July 2019

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Oct 2019
  2. Study start11 Oct 2018
  3. Primary completion13 May 2019
  4. Study completion7 Jul 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04135222
Sponsor's protocol ID
kb245/2018
Acronym
(CBCT)(CAD)
Status last verified
Oct 2019
First submitted
19 Sep 2019
Last updated
22 Oct 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Periodontal Diseases, run by Wroclaw Medical University at 1 site in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

determination the gingival and the periodontal phenotype (time frame: October 2018 to July 2019). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2019.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in