What side effects are associated with this type of intervention?

Common treatments for gum disease, such as local drug delivery agents (LDAs) like minocycline gel and antimicrobial photodynamic therapy (aPDT), can have side effects including localized irritation, allergic reactions, and temporary staining of teeth or gums. Non-invasive imaging techniques like intra-oral ultrasound, which reduce radiation exposure, generally have minimal side effects, primarily limited to potential discomfort during the procedure. Overall, these treatments are considered safe with manageable side effects.

What prior FDA approvals exist?

The FDA has approved various treatments for gum disease, including antimicrobial mouth rinses, antibiotic gels, and enzyme suppressants. These treatments aim to reduce bacterial load and inflammation in the gums. While intra-oral ultrasound itself is not a treatment but a diagnostic tool, it represents a shift towards non-invasive methods that minimize radiation exposure. This aligns with the broader trend of developing safer, less invasive diagnostic and therapeutic options for managing gum disease.

What other types of research exist?

Promising alternatives to intra-oral ultrasound for gum disease patients in 2024 include low-intensity pulsed ultrasound (LIPUS) for its role in accelerating periodontal wound healing and Er:YAG laser instrumentation for its effectiveness in nonsurgical periodontal therapy. These methods offer non-invasive options that minimize radiation exposure while enhancing treatment outcomes.

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Intraoral Ultrasound Imaging for Gum Disease

N/A

Waitlist Available

Led By Fabiana Marques, PhD

Research Sponsored by University of Alberta

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new way to take pictures of teeth and gums using ultrasound, similar to pregnancy scans. The study focuses on orthodontic patients aged 10-60 years old who need frequent imaging. Unlike current methods that use radiation, ultrasound is safe and does not expose patients to harmful rays. Ultrasound imaging in dentistry has been extensively explored in recent years due to its non-invasive nature and lack of harmful ionizing radiation.

Who is the study for?

This trial is for males and females aged 10-60 with all permanent teeth, undergoing CBCT imaging for orthodontic records. It's suitable for those with mild to moderate dental crowding but not for individuals missing teeth, having severe crowding, gum recession, past braces treatment, poor oral hygiene or craniofacial syndromes.

What is being tested?

The study tests the use of intraoral ultrasound as a non-invasive and radiation-free alternative to CBCT in imaging the tooth-gum complex during orthodontic treatment. The goal is to see if it can reliably visualize bone and gingiva around misaligned teeth.

What are the potential side effects?

Intraoral ultrasound does not involve ionizing radiation and is generally considered safe with minimal risks. Side effects are rare but may include discomfort from holding the probe in the mouth.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Alveolar bone thickness

Cemento-enamel junction identification

Distance from alveolar bone crest to the cemento-enamel junction

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Ultrasound scanningExperimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Intraoral ultrasound

2021

N/A

~70

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for gum disease include mechanical debridement (scaling and root planing), photodynamic therapy (PDT), and the use of lasers. Mechanical debridement involves the physical removal of plaque and tartar from tooth surfaces and beneath the gums, which helps reduce bacterial load and inflammation. Photodynamic therapy uses light-activated compounds to destroy bacteria, although its effectiveness as an adjunct to traditional treatments is debated. Laser therapy can target and reduce bacterial populations and promote tissue healing. Intra-oral ultrasound is a non-invasive imaging technique that uses sound waves to visualize bone and gingiva, reducing the need for radiation exposure from traditional X-rays. This is particularly beneficial for patients requiring frequent monitoring, such as those undergoing orthodontic treatment, as it minimizes cumulative radiation risks.

Do Lasers Have an Adjunctive Role in Initial Non-Surgical Periodontal Therapy? A Systematic Review.Photonic Therapy in Periodontal Diseases an Overview with Appraisal of the Literature and Reasoned Treatment Recommendations.Is nonsurgical management effective in temporomandibular joint disorders? - A systematic review and meta-analysis.