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NCT Number: NCT05470023

Imaging-based Assessment of Oral Biofilm and Gingival Health

The purpose of this research study is to develop a better way of measuring the health of patients' mouth using photographs and imaging software. The investigators will also study the specific effects of individual toothpastes and mouthwashes on oral health.

Participants who have volunteered to be in the study will be asked to use a toothpaste or over a period of 7 days to 6 months. The investigators will determine the participants' oral plaque levels, gum health, and saliva (spit) production with clinical exams as well as photographs of the participants' mouths. It is the hope of the study team to find better ways of assessing the health of patients' mouths and to identify whether gum health can be improved by specific toothpastes or mouthwashes.

Recruiting

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Key information

Conditions

Plaque, Dental Dental Deposits Dental Plaque Gingival Diseases Gingivitis Infections Mouth Diseases Periodontal Diseases Stomatognathic Diseases Tooth Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Participants will be asked whether they fulfill study inclusion/exclusion criteria. If recruited, they will be asked to sign the informed consent form. No professional dental cleaning will be performed before or during the trial in order to avoid the influence this would have on the data gathered. Participants will be randomly assigned to use one of the oral care products, which are all OTC products and will be used in the intended manner.

For toothpastes, participants will be asked to brush twice daily for the study duration with one of the following test dental gels: LivFresh Dental Gel (Livionex, Los Gatos, CA); LivFree Dental Gel (Los Gatos, CA); AIM (Church and Dwight, Ewing, NJ); Parodontax (GSK, Philadelphia, PA); Crest Prohealth (P&G, Cincinnati, OH); and Colgate Total (Colgate-Palmolive, New York, NY). A standard Oral B ProFlexR toothbrush will be provided to each volunteer, and participants will be trained in standard sulcular brushing technique. Participants will brush participants' teeth two hours prior to each visit and refrain from eating from that time onwards until after participants' visit. Participants allocated to mouthrinse use will continue with participants' usual oral hygiene protocol; additionally, the participants will be asked to rinse twice daily with 1 capful for 1 minute with the Lumineux Mouthrinse (Lumineux, Beverley Hills, CA) directly after brushing participants' teeth. Plaque levels (P.I.), gingival inflammation, and sulcus bleeding (mSBI) will be recorded.

A standardized periodontal probe will be used to measure pockets. Saliva production will be measured by asking participants to expectorate into a graduated cylinder for 5 minutes. Saliva will not be stored or analyzed in any way.

Volunteers will be photographed and evaluated on all study dates by the same blinded, pre-calibrated investigator. Photographs will be recorded using a standard dental intraoral camera, which only records intraoral images, thus automatically rendering the images unidentifiable with regard to each subject's facial appearance. These photos will not show the subject's face but will focus on the subject's mouth. Participants will be asked whether participants fulfill study inclusion/exclusion criteria inclusion/exclusion criteria.

Study duration will be 7 days or 1, 3, or 6 months. Each visit will last approximately 30 minutes. Initially, study duration will be 7 days as the investigators develop the imaging- based techniques. Once the techniques are finalized, study duration will be incrementally increased to 1 month, then 3 months, then 6 months to validate and refine the imaging-based techniques.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • At least 18 years of age or older
  • In good general health

Exclusion criteria

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

Treatment and study plan

OTC Toothpastes or Mouthrinses

Other

OTC Toothpastes or mouthrinses used according to standard of care

Primary outcomes

  1. Plaque level at Week 1

    Time frame: 1 week

    Oral plaque will be measured using the gold standard plaque index (0-5; 0-best, 5 worst).

  2. Plaque level at Month 1

    Time frame: 1 month

    Oral plaque will be measured using the gold standard plaque index (0-5; 0-best, 5 worst).

  3. Plaque level at Month 3

    Time frame: 3 months

    Oral plaque will be measured using the gold standard plaque index (0-5; 0-best, 5 worst).

  4. Plaque level at Month 6

    Time frame: 6 months

    Oral plaque will be measured using the gold standard plaque index (0-5; 0-best, 5 worst).

  5. Gingival health (gingival index) at Week 1

    Time frame: 1 week

    Gingival health will be measured using the gold standard gingival index (0-3; 0-best, 3 worst).

  6. Gingival health (gingival index) at Month 1

    Time frame: 1 month

    Gingival health will be measured using the gold standard gingival index (0-3; 0-best, 3 worst).

  7. Gingival health (gingival index) at Month 3

    Time frame: 3 months

    Gingival health will be measured using the gold standard gingival index (0-3; 0-best, 3 worst).

  8. Gingival health (gingival index) at Month 6

    Time frame: 6 months

    Gingival health will be measured using the gold standard gingival index (0-3; 0-best, 3 worst).

  9. Gingival health (sulcus bleeding index) at Week 1

    Time frame: 1 week

    Gingival health will be measured using the gold standard modified sulcus bleeding index (0-3; 0-best, 3 worst).

  10. Gingival health (sulcus bleeding index) at Month 1

    Time frame: 1 month

    Gingival health will be measured using the gold standard modified sulcus bleeding index (0-3; 0-best, 3 worst).

  11. Gingival health (sulcus bleeding index) at Month 3

    Time frame: 3 months

    Gingival health will be measured using the gold standard modified sulcus bleeding index (0-3; 0-best, 3 worst).

  12. Gingival health (sulcus bleeding index) at Month 6

    Time frame: 6 months

    Gingival health will be measured using the gold standard modified sulcus bleeding index (0-3; 0-best, 3 worst).

Study contacts

Contact information is provided by the study sponsor or research team.

Dr. Petra Wilder-Smith

CONTACT

[email protected]

949-824-7632

Nicole Wakida, PhD

CONTACT

[email protected]

949-824-4360

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Registry information

Important dates

Study start
2022
Primary completion
2028
Study completion
2028
First posted
Jul 22, 2022
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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