Imaging-based Assessment of Oral Biofilm and Gingival Health

Not Applicable

Recruiting

• Conditions: Gingivitis; Plaque, Dental
• Interventions: Other: OTC Toothpastes or Mouthrinses

• Registration Number: NCT05470023
• Lead Sponsor: University of California, Irvine

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.

Study Timeline

• Study First Submitted: 2022-07-15
• Study First Submitted QC: 2022-07-19
• Study First Posted: 2022-07-22
• Study Start: 2022-09-01
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-14
• Last Update Posted: 2025-01-16
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 275

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Brushing with LivFresh Dental Gel	OTC Toothpastes or Mouthrinses	Subjects will brush twice daily for the study duration with LivFresh Dental Gel with a standard Oral B ProFlexR toothbrush and will be trained in standard sulcular brushing technique. Subjects will brush their teeth two hours prior to each visit and refrain from eating from that time onwards until after their visit. Plaque levels, gingival inflammation, and sulcus bleeding will be recorded. A standardized periodontal probe will be used to measure pockets. Subjects will expectorate into a graduated cylinder for 5 minutes and their saliva production will be measured. Saliva will not be stored or analyzed in any way. Subjects 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. These photos will not show the subject's face but will focus on the subject's mouth.
Brushing with Colgate Total Dental Gel	OTC Toothpastes or Mouthrinses	Subjects will brush twice daily for the study duration with Colgate Total Dental Gel with a standard Oral B ProFlexR toothbrush and will be trained in standard sulcular brushing technique. Subjects will brush their teeth two hours prior to each visit and refrain from eating from that time onwards until after their visit. Plaque levels, gingival inflammation, and sulcus bleeding will be recorded. A standardized periodontal probe will be used to measure pockets. Subjects will expectorate into a graduated cylinder for 5 minutes and their saliva production will be measured. Saliva will not be stored or analyzed in any way. Subjects 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. These photos will not show the subject's face but will focus on the subject's mouth.
Brushing with Crest Prohealth Dental Gel	OTC Toothpastes or Mouthrinses	Subjects will brush twice daily for the study duration with Crest Prohealth Dental Gel with a standard Oral B ProFlexR toothbrush and will be trained in standard sulcular brushing technique. Subjects will brush their teeth two hours prior to each visit and refrain from eating from that time onwards until after their visit. Plaque levels, gingival inflammation, and sulcus bleeding will be recorded. A standardized periodontal probe will be used to measure pockets. Subjects will expectorate into a graduated cylinder for 5 minutes and their saliva production will be measured. Saliva will not be stored or analyzed in any way. Subjects 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. These photos will not show the subject's face but will focus on the subject's mouth.
Brushing with LivFree Dental Gel	OTC Toothpastes or Mouthrinses	Subjects will brush twice daily for the study duration with LivFree Dental Gel with a standard Oral B ProFlexR toothbrush and will be trained in standard sulcular brushing technique. Subjects will brush their teeth two hours prior to each visit and refrain from eating from that time onwards until after their visit. Plaque levels, gingival inflammation, and sulcus bleeding will be recorded. A standardized periodontal probe will be used to measure pockets. Subjects will expectorate into a graduated cylinder for 5 minutes and their saliva production will be measured. Saliva will not be stored or analyzed in any way. Subjects 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. These photos will not show the subject's face but will focus on the subject's mouth.
Brushing with AIM Dental Gel	OTC Toothpastes or Mouthrinses	Subjects will brush twice daily for the study duration with AIM Dental Gels with a standard Oral B ProFlexR toothbrush and will be trained in standard sulcular brushing technique. Subjects will brush their teeth two hours prior to each visit and refrain from eating from that time onwards until after their visit. Plaque levels, gingival inflammation, and sulcus bleeding will be recorded. A standardized periodontal probe will be used to measure pockets. Subjects will expectorate into a graduated cylinder for 5 minutes and their saliva production will be measured. Saliva will not be stored or analyzed in any way. Subjects 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. These photos will not show the subject's face but will focus on the subject's mouth.
Rinsing with Lumineux or Listerine Mouthwashes	OTC Toothpastes or Mouthrinses	Subjects will be asked to rinse twice daily with 1 capful for 1 minute with Lumineux or Listerine Mouthwashes directly after brushing their teeth, while continuing with their usual oral hygiene protocol. Plaque levels, gingival inflammation, and sulcus bleeding will be recorded. A standardized periodontal probe will be used to measure pockets. Subjects will expectorate into a graduated cylinder for 5 minutes and their saliva production will be measured. Saliva will not be stored or analyzed in any way. Subjects 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. These photos will not show the subject's face but will focus on the subject's mouth.
Brushing with Parodontax Dental Gel	OTC Toothpastes or Mouthrinses	Subjects will brush twice daily for the study duration with Parodontax Dental Gel with a standard Oral B ProFlexR toothbrush and will be trained in standard sulcular brushing technique. Subjects will brush their teeth two hours prior to each visit and refrain from eating from that time onwards until after their visit. Plaque levels, gingival inflammation, and sulcus bleeding will be recorded. A standardized periodontal probe will be used to measure pockets. Subjects will expectorate into a graduated cylinder for 5 minutes and their saliva production will be measured. Saliva will not be stored or analyzed in any way. Subjects 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. These photos will not show the subject's face but will focus on the subject's mouth.

Primary Outcome Measures

Name	Time	Method
Plaque level at Month 3	3 months	Oral plaque will be measured using the gold standard plaque index (0-5; 0-best, 5 worst).
Gingival health (gingival index) at Month 3	3 months	Gingival health will be measured using the gold standard gingival index (0-3; 0-best, 3 worst).
Gingival health (sulcus bleeding index) at Month 1	1 month	Gingival health will be measured using the gold standard modified sulcus bleeding index (0-3; 0-best, 3 worst).
Gingival health (sulcus bleeding index) at Month 6	6 months	Gingival health will be measured using the gold standard modified sulcus bleeding index (0-3; 0-best, 3 worst).
Plaque level at Week 1	1 week	Oral plaque will be measured using the gold standard plaque index (0-5; 0-best, 5 worst).
Plaque level at Month 6	6 months	Oral plaque will be measured using the gold standard plaque index (0-5; 0-best, 5 worst).
Gingival health (gingival index) at Month 1	1 month	Gingival health will be measured using the gold standard gingival index (0-3; 0-best, 3 worst).
Gingival health (gingival index) at Month 6	6 months	Gingival health will be measured using the gold standard gingival index (0-3; 0-best, 3 worst).
Plaque level at Month 1	1 month	Oral plaque will be measured using the gold standard plaque index (0-5; 0-best, 5 worst).
Gingival health (gingival index) at Week 1	1 week	Gingival health will be measured using the gold standard gingival index (0-3; 0-best, 3 worst).
Gingival health (sulcus bleeding index) at Week 1	1 week	Gingival health will be measured using the gold standard modified sulcus bleeding index (0-3; 0-best, 3 worst).
Gingival health (sulcus bleeding index) at Month 3	3 months	Gingival health will be measured using the gold standard modified sulcus bleeding index (0-3; 0-best, 3 worst).

Trial Locations

Locations (1)

Beckman Laser Institute and Medical Clinic; 🇺🇸 Irvine, California, United States