Clinical trial NCT05470023: Imaging-based Assessment of Oral Biofilm and Gingival Health
Official title: Imaging-based Assessment of Oral Biofilm and Gingival Health
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Plaque, Dental
Gingivitis
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2022-07-22
Enrollment: 275
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects will be randomized to different treatments.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Plaque level at Week 1
timeFrame: 1 week
measure: Plaque level at Month 1
timeFrame: 1 month
measure: Plaque level at Month 3
timeFrame: 3 months
measure: Plaque level at Month 6
timeFrame: 6 months
measure: Gingival health (gingival index) at Week 1
timeFrame: 1 week
measure: Gingival health (gingival index) at Month 1
timeFrame: 1 month
measure: Gingival health (gingival index) at Month 3
timeFrame: 3 months
measure: Gingival health (gingival index) at Month 6
timeFrame: 6 months
measure: Gingival health (sulcus bleeding index) at Week 1
timeFrame: 1 week
measure: Gingival health (sulcus bleeding index) at Month 1
timeFrame: 1 month
measure: Gingival health (sulcus bleeding index) at Month 3
timeFrame: 3 months
measure: Gingival health (sulcus bleeding index) at Month 6
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Beckman Laser Institute and Medical Clinic
state: California
Study officials:
affiliation: Beckman Laser Institute University of California Irvine
name: Dr. Petra Wilder-Smith
role: PRINCIPAL_INVESTIGATOR
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