Palatal Masticatory Mucosa ThicknessNCT05124418
A New Non-invasive Method to Assess and Measure Palatal Masticatory Mucosa Using Dynamic Navigation System
A study testing palatal masticatory mucosa thickness measurement in people with Palatal Masticatory Mucosa Thickness, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Periodontal plastic surgery is widely used to improve the esthetic and functional demands of patients. The palatal masticatory mucosa is the main donor area. A lot of methods to evaluate the thickness of palatal soft tissue were used. However, the methods published before were invasive or non-reproducible. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Palatal Masticatory Mucosa Thickness
- What is being tested?
- palatal masticatory mucosa thickness measurement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteTaiwan
- Study dates
- 9 Sep 2021to 30 Jun 2024
- Phase
- Interventional
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Above 20 years old
- The patient need dental implant surgery in maxilla
- The patient have at least complete canine to second molar at one side
- Periodontaliy healthy patients
- The patient could sign for the consent form.
Who cannot join
- patients can not receive dental implant surgery
- fuzzy palatal alveolar bone line
- all maxillary posterior teeth with metal crowns
- all posterior teeth are missing at one side over maxilla
- all maxillary posterior teeth with hyper-mobility
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
CHEN-YING WANG, PhD, jywang8919@ntu.edu.tw
About this study
Periodontal plastic surgery is widely used to improve the esthetic and functional demands of patients. The palatal masticatory mucosa is the main donor area. A lot of methods to evaluate the thickness of palatal soft tissue were used. However, the methods published before were invasive or non-reproducible. Therefore, the aim of this study was to investigate the accuracy of the novel invasive method to evaluate the thickness of palatal masticatory mucosa thickness.
Twelve periodontally healthy patients who will have CBCT on maxilla for implant surgery will be recruited in this study. Each patient will be measured at 15 points of palatal masticatory mucosa over canine to the second molar area, it will be done by a dynamic navigation system (test group) and periodontal probe piercing (control group). The data will be analyzed to evaluate the accuracy of dynamic navigation in the measurement of palatal masticatory mucosa thickness.
- Conditions
- Palatal Masticatory Mucosa Thickness
- Being tested
- palatal masticatory mucosa thickness measurement
- Keywords
- cone beam computed tomography,dynamic navigation,Palatal maticatory mucosa thickness,non-invasive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
palatal masticatory mucosa thickness measurementDiagnostic test
Measure the thickness of palatal masticatory mucosa by a dynamic navigation system (Navident®, ClaroNav Inc., Toronto, Canada) and periodontal probe piercing.
| Study group | Role | What they receive |
|---|---|---|
| Palatal masticatory mucosa thickness measurement | Other | Not described Receives: Diagnostic Test: palatal masticatory mucosa thickness measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
measure thickness of palatal masticatory mucosa using dynamic navigation system (in mm) and periodontal probe (in mm)
Measured: immediately after examination
Secondary outcomes (1)
Information of palatal masticatory mucosa thickness in Taiwanese people
Measured: immediately after examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2021
- Study start9 Sep 2021
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Palatal Masticatory Mucosa ThicknessStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- CHEN-YING WANG, PhD, Study director, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05124418
- Sponsor's protocol ID
- 202103099DIND
- Status last verified
- Feb 2023
- First submitted
- 31 Oct 2021
- Last updated
- 3 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Non-invasive Method to Assess and Measure Palatal Masticatory Mucosa Using Dynamic Navigation System
- ClinicalTrials.gov ID
- NCT05124418
- Acronym / sponsor ID
- 202103099DIND
- Conditions
- Palatal Masticatory Mucosa Thickness
- Keywords
- cone beam computed tomography,dynamic navigation,Palatal maticatory mucosa thickness,non-invasive
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 9 Sep 2021 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 18 Nov 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.
Periodontal plastic surgery is widely used to improve the esthetic and functional demands of patients. The palatal masticatory mucosa is the main donor area. A lot of methods to evaluate the thickness of palatal soft tissue were used. However, the methods published before were invasive or non-reproducible. Therefore, the aim of this study was to investigate the accuracy of the novel invasive method to evaluate the thickness of palatal masticatory mucosa thickness.
Twelve periodontally healthy patients who will have CBCT on maxilla for implant surgery will be recruited in this study. Each patient will be measured at 15 points of palatal masticatory mucosa over canine to the second molar area, it will be done by a dynamic navigation system (test group) and periodontal probe piercing (control group). The data will be analyzed to evaluate the accuracy of dynamic navigation in the measurement of palatal masticatory mucosa thickness.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Palatal masticatory mucosa thickness measurement | Other | Diagnostic Test: palatal masticatory mucosa thickness measurement |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Above 20 years old
- The patient need dental implant surgery in maxilla
- The patient have at least complete canine to second molar at one side
- Periodontaliy healthy patients
- The patient could sign for the consent form.
Key exclusion criteria (6 listed)
- patients can not receive dental implant surgery
- fuzzy palatal alveolar bone line
- all maxillary posterior teeth with metal crowns
- all posterior teeth are missing at one side over maxilla
- all maxillary posterior teeth with hyper-mobility
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 |
|---|---|---|
| palatal masticatory mucosa thickness measurementMeasure the thickness of palatal masticatory mucosa by a dynamic navigation system (Navident®, ClaroNav Inc., Toronto, Canada) and periodontal probe piercing. | Diagnostic test | Palatal masticatory mucosa thickness measurement |
Primary outcome
measure thickness of palatal masticatory mucosa using dynamic navigation system (in mm) and periodontal probe (in mm)
Time frame: immediately after examination
1 secondary outcome
Information of palatal masticatory mucosa thickness in Taiwanese people
Time frame: immediately after examination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2023.
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.
CHEN-YING WANG, PhD study director
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing palatal masticatory mucosa thickness measurement in people with Palatal Masticatory Mucosa Thickness, run by National Taiwan University Hospital at 1 site in Taiwan.
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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 3 Feb 2023. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact CHEN-YING WANG, PhD (+886-972651897, jywang8919@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measure thickness of palatal masticatory mucosa using dynamic navigation system (in mm) and periodontal probe (in mm) (time frame: immediately after examination). 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 3 Feb 2023.