Imaging-based Assessment of Oral Biofilm and Gingival Health

Study Overview
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Brief Summary
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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
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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.

Official Title
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Imaging-based Assessment of Oral Biofilm and Gingival Health

Conditions
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Plaque, Dental, Gingivitis

Intervention / Treatment
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* Other: OTC Toothpastes or Mouthrinses


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Subjects will be randomized to different treatments.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Brushing with LivFresh Dental Gel<br>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. | Other: OTC Toothpastes or Mouthrinses<br>* OTC Toothpastes or mouthrinses used according to standard of care<br>|
| Active Comparator: Brushing with LivFree Dental Gel<br>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. | Other: OTC Toothpastes or Mouthrinses<br>* OTC Toothpastes or mouthrinses used according to standard of care<br>|
| Active Comparator: Brushing with AIM Dental Gel<br>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. | Other: OTC Toothpastes or Mouthrinses<br>* OTC Toothpastes or mouthrinses used according to standard of care<br>|
| Active Comparator: Brushing with Crest Prohealth Dental Gel<br>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. | Other: OTC Toothpastes or Mouthrinses<br>* OTC Toothpastes or mouthrinses used according to standard of care<br>|
| Active Comparator: Brushing with Parodontax Dental Gel<br>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. | Other: OTC Toothpastes or Mouthrinses<br>* OTC Toothpastes or mouthrinses used according to standard of care<br>|
| Active Comparator: Brushing with Colgate Total Dental Gel<br>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. | Other: OTC Toothpastes or Mouthrinses<br>* OTC Toothpastes or mouthrinses used according to standard of care<br>|
| Active Comparator: Rinsing with Lumineux or Listerine Mouthwashes<br>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. | Other: OTC Toothpastes or Mouthrinses<br>* OTC Toothpastes or mouthrinses used according to standard of care<br>|

What is the study measuring?
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Primary Outcome Measures

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