A New Non-invasive Method to Assess and Measure Palatal Masticatory Mucosa Using Dynamic Navigation System

February 2, 2023 updated by: National Taiwan University Hospital

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion criteria:

  1. Above 20 years old
  2. The patient need dental implant surgery in maxilla
  3. The patient have at least complete canine to second molar at one side
  4. Periodontaliy healthy patients
  5. The patient could sign for the consent form.

Exclusion criteria:

  1. patients can not receive dental implant surgery
  2. fuzzy palatal alveolar bone line
  3. all maxillary posterior teeth with metal crowns
  4. all posterior teeth are missing at one side over maxilla
  5. all maxillary posterior teeth with hyper-mobility
  6. Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Palatal masticatory mucosa thickness measurement
Diagnostic test: palatal masticatory mucosa thickness measurement
Measure the thickness of palatal masticatory mucosa by a dynamic navigation system (Navident®, ClaroNav Inc., Toronto, Canada) and periodontal probe piercing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
measure thickness of palatal masticatory mucosa using dynamic navigation system (in mm) and periodontal probe (in mm)
Time Frame: immediately after examination
immediately after examination

Secondary Outcome Measures

Outcome Measure
Time Frame
Information of palatal masticatory mucosa thickness in Taiwanese people
Time Frame: immediately after examination
immediately after examination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Study Director: CHEN-YING WANG, PhD, National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 9, 2021

Primary Completion (Anticipated)

June 30, 2024

Study Completion (Anticipated)

June 30, 2024

Study Registration Dates

First Submitted

October 31, 2021

First Submitted That Met QC Criteria

November 15, 2021

First Posted (Actual)

November 18, 2021

Study Record Updates

Last Update Posted (Actual)

February 3, 2023

Last Update Submitted That Met QC Criteria

February 2, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 202103099DIND

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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