Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID05470023

Imaging-based Assessment of Oral Biofilm and Gingival Health Using OTC Toothpastes and Mouthwashes

Led by University of California, Irvine · Updated on 2025-12-23

275

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to develop improved methods for measuring oral health by using photographs and imaging software. The study evaluates the effects of different over-the-counter toothpastes and mouthwashes on oral health, focusing on plaque levels, gum health, and saliva production. The goal is to find better ways to assess mouth health and determine if specific products can improve gum condition. Participants will be randomly assigned to use one of several toothpastes or mouthrinses. Toothpaste users will brush twice daily with a provided standard toothbrush and a specific dental gel, following a trained brushing technique. Mouthrinse users will continue their usual oral hygiene and rinse twice daily with a mouthwash after brushing. Study durations vary from 7 days to 6 months, with the initial period for developing imaging techniques and longer periods to validate them. During study visits, participants will have clinical assessments including plaque, gum inflammation, and bleeding recorded, as well as saliva production measured by expectorating into a cylinder. Photos of the mouth will be taken using an intraoral camera that does not capture the face. Visits last about 30 minutes, and the same investigator will evaluate participants at each visit. The study carefully avoids professional dental cleaning to maintain consistent data.

CONDITIONS

Brief Title

Imaging-based Assessment of Oral Biofilm and Gingival Health

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • At least 18 years of age or older
  • In good general health
Not Eligible

You will not qualify if you...

  • History of allergy or intolerance of oral hygiene products such as toothpastes and mouthrinses

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 7 days or 1, 3, or 6 months

Participants use assigned over-the-counter toothpastes or mouthrinses twice daily for the study duration, following training on brushing techniques. They refrain from eating two hours before each visit. Plaque levels, gingival inflammation, sulcus bleeding, pocket depth, and saliva production are measured. Participants are photographed using an intraoral camera focusing on the mouth at each visit.

Visits at baseline and at Weeks 1, Month 1, Month 3, and Month 6 depending on study duration

Trial Site Locations

Total: 1 location

1

Beckman Laser Institute and Medical Clinic

Irvine, California, United States, 92617

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Research Team

D

Dr. Petra Wilder-Smith

N

Nicole Wakida, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

7

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Published Research Related To This Trial

Effects of amine and stannous fluorides on plaque accumulation and gingival health in orthodontic patients treated with fixed appliances: a pilot study.

Melinda Madlena, Jolan Banoczy, Gergely Gotz...

https://pubmed.ncbi.nlm.nih.gov/22692271