Periodontal DiseasesNCT04845581
Comparison of the Effectiveness of the USG and CBCT Combined With Intraoral Scanning Determing the Gingival Phenotype in the Healthy Periodontium
An observational study of Periodontal Diseases, run by Wroclaw Medical University at 1 site in Poland.
Trial 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. 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?
- Diagnostic tests: Determination of the gingival phenotype, measure gingival thickness and width of keratinized tissue
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 sitePoland
- Study dates
- 11 Oct 2018to 2 Aug 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 oral hygiene
- healthy periodontium - API ratio\<15%, BOP\<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
Who cannot join
- general diseases
- poor oral hygiene
- non healthy periodontium - API ratio\>15%, BOP\>10%
- loss of clinical attachment in the examined areas (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: 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.
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.
Read the 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.
- Conditions
- Periodontal Diseases
- Being tested
- Diagnostic tests: Determination of the gingival phenotype, measure gingival thickness and width of keratinized tissue
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic tests: Determination of the gingival phenotype, measure gingival thickness and width of keratinized tissueProcedure or surgery
Gingival thickness was measured using UGTM method and CBCT/ CAD with PDIP technology at upper incisors and canines in three points localized midbucally : Free gingival thickness (FGT), supracrestal ( SGT) and crestal (CGT). Width of keratinized tissue was measured using periodontal probe calibrated for 1 mm. The gingival phenotype was determined by both methods according to the following criteria: GT ≤ 0,7 mm - thin gingival phenotype, GT \> 0,7 mm ≤ 1,0 mm - medium gingival phenotype, GT \> 1,0 mm - thick gingival phenotype. Toincrease the repeatability of the results, two researchers tested the same values twice on 2days interval between sessions.
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination the gingival phenotype
The UGTM and CBCT/CAD/PDIP methods are useful to determining of gingival phenotype but more accurate and repeatability is UGTM. The presence of a positive correlation between SGT and WKT indicates the need to measured these parameters for the evaluation of GP. T. It is very important to determine the gingival phenotype for each dento-gingival unit especially before complicated dental treatment.
Measured: october 2018 to august 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2021
- Study start11 Oct 2018
- Primary completion20 Jul 2019
- Study completion2 Aug 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
- Case only
- 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, wroclaw medical univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04845581
- Sponsor's protocol ID
- kb245/2018(2)
- Status last verified
- Jan 2020
- First submitted
- 22 Mar 2021
- Last updated
- 15 Apr 2021
- 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 15 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04845581
- Acronym / sponsor ID
- kb245/2018(2)
- 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
- 20 Jul 2019 (actual)
- Study completion
- 2 Aug 2019 (actual)
- First posted
- 15 Apr 2021 (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.
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.
Study design
- Observational model
- Case only
- 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 oral hygiene
- healthy periodontium - API ratio\<15%, BOP\<10%
- no loss of clinical attachment in the examined areas (CAL=0)
- no use of drugs
Key exclusion criteria (8 listed)
- general diseases
- poor oral hygiene
- non healthy periodontium - API ratio\>15%, BOP\>10%
- loss of clinical attachment in the examined areas (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 |
|---|---|---|
| Diagnostic tests: Determination of the gingival phenotype, measure gingival thickness and width of keratinized tissueGingival thickness was measured using UGTM method and CBCT/ CAD with PDIP technology at upper incisors and canines in three points localized midbucally : Free gingival thickness (FGT), supracrestal ( SGT) and crestal (CGT). Width of keratinized tissue was measured using periodontal probe calibrated for 1 mm. The gingival phenotype was determined by both methods according to the following criteria: GT ≤ 0,7 mm - thin gingival phenotype, GT \> 0,7 mm ≤ 1,0 mm - medium gingival phenotype, GT \> 1,0 mm - thick gingival phenotype. Toincrease the repeatability of the results, two researchers tested the same values twice on 2days interval between sessions. | Procedure or surgery | – |
Primary outcome
Determination the gingival phenotype
Time frame: october 2018 to august 2019
The UGTM and CBCT/CAD/PDIP methods are useful to determining of gingival phenotype but more accurate and repeatability is UGTM. The presence of a positive correlation between SGT and WKT indicates the need to measured these parameters for the evaluation of GP. T. It is very important to determine the gingival phenotype for each dento-gingival unit especially before complicated dental treatment.
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 15 Apr 2021.
- 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
wroclaw medical univeristy
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 15 Apr 2021. 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 phenotype (time frame: october 2018 to august 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 15 Apr 2021.