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.
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.
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.
- Conditions
- Periodontal Diseases
- 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.
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.
- First posted22 Oct 2019
- Study start11 Oct 2018
- Primary completion13 May 2019
- Study completion7 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Wroclaw Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- wojciech bednarz, prof, Study director, Medical Uniwersity Wroclaw
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04135222
- Acronym / sponsor ID
- (CBCT)(CAD) / kb245/2018
- Conditions
- Periodontal Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Wroclaw Medical UniversityUniversity, hospital or other
- Study start
- 11 Oct 2018 (actual)
- Primary completion
- 13 May 2019 (actual)
- Study completion
- 7 Jul 2019 (actual)
- First posted
- 22 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 24 to 54 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- male 16 female 14
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measurements of gingiva thicknessMeasurements 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). | Diagnostic test | – |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
wojciech bednarz, prof study director
Medical Uniwersity Wroclaw
1 site in 1 country: see every site and its status.
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.