Intraoral Ultrasound Imaging of Tooth-periodontium Complex

NCT04971642 | Completed

• 1 other identifier: Pro00099721
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

Misaligned teeth are very common in the population and are commonly known as malocclusion. This happens when the upper teeth do not align properly with the lower teeth. It can lead to difficulty in jaw movement, chewing, speech, and gum disease. Correction of malocclusion requires orthodontic (braces) treatment. Currently, the imaging technique known as cone-beam computed tomography (CBCT) has been routinely used in orthodontic diagnosis and treatment planning for patients with malocclusion. Although CBCT provides better information than conventional dental X-rays, it typically delivers more harmful radiation to the patients. This is especially important as radiation from repeated X-ray imaging during dental monitoring visits can be cumulative. Ultrasound is commonly used in medical imaging. The ultrasound method is non-invasive, cost-effective, and free of ionizing radiation. The application of ultrasound has been investigated in many fields in Dentistry. We plan to evaluate the ability of intra-oral ultrasound to see the bone and gingiva around the tooth for patients under orthodontic treatment. If ultrasound is found to be a reliable tool in imaging the tooth-gum complex, children and adolescents will benefit immensely from the decreased radiation risks and reduced cancer rate.

Conditions

Alveolar Bone Loss; Periodontitis

Keywords

ultrasound; periodontium

Outcome Measures

Primary Outcomes (5)

• Distance from alveolar bone crest to the cemento-enamel junction

  It is the linear measurement distance in millimeters (mm) from the alveolar bone crest to the cemento-enamel junction anatomical structures observed in the Ultrasound image. It will be evaluated using an image software.

  through study completion, an average of 1 year

• Distance from cemento-enamel junction to the gingival margin

  It is the linear measurement distance in millimeters (mm) from the cemento-enamel junction to the gingival margin observed in the Ultrasound image. It will be evaluated through an image software.

  through study completion, an average of 1 year

• Gingival thickness

  It is the linear measurement of the thickness of gingival tissue at the alveolar bone crest level in millimeters (mm) observed in the Ultrasound image. It will be evaluated using an image software

  through study completion, an average of 1 year

• Alveolar bone thickness

  It is the linear measurement of the alveolar bone thickness at the alveolar bone crest level in millimeters (mm) observed in the Ultrasound image. It will be evaluated using an image software.

  through study completion, an average of 1 year

• Cemento-enamel junction identification

  The Identification of the cemento-enamel junction will be done by adding a point to this anatomical structure in the ultrasound image. It will be evaluated using an image software

  through study completion, an average of 1 year

Study Arms (1)

Ultrasound scanning

EXPERIMENTAL

The subjects recruited are existing patients of the Orthodontic Clinic - Oral Health Clinic-Dentistry, University of Alberta. An intraoral ultrasound scanning will be done on the buccal side of the upper and lower incisor/canine/premolar/molar teeth for a total of sixteen (16) teeth (four(4) teeth in each of the four quadrants) of these subjects. The ultrasound scans will be done separately by a research assistant not involved in patient care. The whole procedure for ultrasound scanning and data storage will take about 25-30 min including 3-5 min preparation time and 22-25 min of data acquisition and storage time.

Device: Intraoral ultrasound

Interventions

Intraoral ultrasound DEVICE

Intraoral ultrasound scanning of the periodontium complex

Ultrasound scanning

Eligibility Criteria

• Age: 10 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Males or females in the age group of 10-60 years old
• Individuals with permanent dentition
• Dental malocclusion with mild to moderate crowding
• Individuals undergoing CBCT imaging as part of Orthodontic diagnostic records Individuals in the age group of 10-60 years would have a full complement of permanent teeth erupted which will help standardize the research methodology to prevent an error in data acquisition, caused by the overlap of dental tissue in the mixed dentition period.

You may not qualify if:

• Participants with missing permanent teeth, gingival recession (below CEJ), severe crowding, or a history of corrective orthodontics will be excluded. Any co-factors (previous orthodontic treatment) that might influence the ultrasound findings, will be excluded. Participants with unfavorable oral hygiene will be excluded due to the ambiguity associated with data acquisition in an inflamed periodontium. Also, participants presenting with craniofacial syndromes will be excluded due to the factors related to changes in craniofacial anatomy (maxilla-mandible anatomy)

Sponsors & Collaborators

• University of Alberta: lead
• Mitacs: collaborator

Study Sites (1)

Oral Health Clinic, 8th Floor, Kaye Edmonton Dental Clinic.

Edmonton, Alberta, T6G 1Z1, Canada

Location

Related Publications (4)

• Nguyen KCT, Duong DQ, Almeida FT, Major PW, Kaipatur NR, Pham TT, Lou EHM, Noga M, Punithakumar K, Le LH. Alveolar Bone Segmentation in Intraoral Ultrasonographs with Machine Learning. J Dent Res. 2020 Aug;99(9):1054-1061. doi: 10.1177/0022034520920593. Epub 2020 May 11.

  PMID: 32392449 BACKGROUND

• Nguyen KT, Le LH, Kaipatur NR, Zheng R, Lou EH, Major PW. High-Resolution Ultrasonic Imaging of Dento-Periodontal Tissues Using a Multi-Element Phased Array System. Ann Biomed Eng. 2016 Oct;44(10):2874-2886. doi: 10.1007/s10439-016-1634-2. Epub 2016 May 9.

  PMID: 27160674 BACKGROUND

• Nguyen KC, Le LH, Kaipatur NR, Major PW. Imaging the Cemento-Enamel Junction Using a 20-MHz Ultrasonic Transducer. Ultrasound Med Biol. 2016 Jan;42(1):333-8. doi: 10.1016/j.ultrasmedbio.2015.09.012. Epub 2015 Nov 3.

  PMID: 26546266 BACKGROUND

• Nguyen KT, Pacheco-Pereira C, Kaipatur NR, Cheung J, Major PW, Le LH. Comparison of ultrasound imaging and cone-beam computed tomography for examination of the alveolar bone level: A systematic review. PLoS One. 2018 Oct 3;13(10):e0200596. doi: 10.1371/journal.pone.0200596. eCollection 2018.

  PMID: 30281591 BACKGROUND

MeSH Terms

Conditions

Alveolar Bone Loss; Periodontitis

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Fabiana Marques, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2021
• First Posted: July 21, 2021
• Study Start: February 10, 2021
• Primary Completion: July 28, 2021
• Study Completion: January 15, 2023
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)