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Imaging-based Assessment of Oral Biofilm and Gingival Health

Primary Purpose

Plaque, Dental, Gingivitis

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
OTC Toothpastes or Mouthrinses
Sponsored by
University of California, Irvine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Plaque, Dental

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Beckman Laser Institute and Medical ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Brushing with LivFresh Dental Gel

Brushing with LivFree Dental Gel

Brushing with AIM Dental Gel

Brushing with Crest Prohealth Dental Gel

Brushing with Parodontax Dental Gel

Brushing with Colgate Total Dental Gel

Rinsing with Lumineux or Listerine Mouthwashes

Arm Description

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.

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.

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 15, 2022
Last Updated
November 1, 2022
Sponsor
University of California, Irvine
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1. Study Identification

Unique Protocol Identification Number
NCT05470023
Brief Title
Imaging-based Assessment of Oral Biofilm and Gingival Health
Official Title
Imaging-based Assessment of Oral Biofilm and Gingival Health
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Irvine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plaque, Dental, Gingivitis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Subjects will be randomized to different treatments.
Masking
ParticipantInvestigator
Masking Description
White tape over receptacle.
Allocation
Randomized
Enrollment
275 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Brushing with LivFresh Dental Gel
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Brushing with LivFree Dental Gel
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Brushing with AIM Dental Gel
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Brushing with Crest Prohealth Dental Gel
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Brushing with Parodontax Dental Gel
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Brushing with Colgate Total Dental Gel
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Rinsing with Lumineux or Listerine Mouthwashes
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
OTC Toothpastes or Mouthrinses
Intervention Description
OTC Toothpastes or mouthrinses used according to standard of care
Primary Outcome Measure Information:
Title
Plaque level at Week 1
Description
Oral plaque will be measured using the gold standard plaque index (0-5; 0-best, 5 worst).
Time Frame
1 week
Title
Plaque level at Month 1
Description
Oral plaque will be measured using the gold standard plaque index (0-5; 0-best, 5 worst).
Time Frame
1 month
Title
Plaque level at Month 3
Description
Oral plaque will be measured using the gold standard plaque index (0-5; 0-best, 5 worst).
Time Frame
3 months
Title
Plaque level at Month 6
Description
Oral plaque will be measured using the gold standard plaque index (0-5; 0-best, 5 worst).
Time Frame
6 months
Title
Gingival health (gingival index) at Week 1
Description
Gingival health will be measured using the gold standard gingival index (0-3; 0-best, 3 worst).
Time Frame
1 week
Title
Gingival health (gingival index) at Month 1
Description
Gingival health will be measured using the gold standard gingival index (0-3; 0-best, 3 worst).
Time Frame
1 month
Title
Gingival health (gingival index) at Month 3
Description
Gingival health will be measured using the gold standard gingival index (0-3; 0-best, 3 worst).
Time Frame
3 months
Title
Gingival health (gingival index) at Month 6
Description
Gingival health will be measured using the gold standard gingival index (0-3; 0-best, 3 worst).
Time Frame
6 months
Title
Gingival health (sulcus bleeding index) at Week 1
Description
Gingival health will be measured using the gold standard modified sulcus bleeding index (0-3; 0-best, 3 worst).
Time Frame
1 week
Title
Gingival health (sulcus bleeding index) at Month 1
Description
Gingival health will be measured using the gold standard modified sulcus bleeding index (0-3; 0-best, 3 worst).
Time Frame
1 month
Title
Gingival health (sulcus bleeding index) at Month 3
Description
Gingival health will be measured using the gold standard modified sulcus bleeding index (0-3; 0-best, 3 worst).
Time Frame
3 months
Title
Gingival health (sulcus bleeding index) at Month 6
Description
Gingival health will be measured using the gold standard modified sulcus bleeding index (0-3; 0-best, 3 worst).
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dr. Petra Wilder-Smith
Phone
949-824-7632
Email
pwsmith@uci.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Hanna Kim
Phone
949-824-2251
Email
hhkim3@uci.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Petra Wilder-Smith
Organizational Affiliation
Beckman Laser Institute University of California Irvine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beckman Laser Institute and Medical Clinic
City
Irvine
State/Province
California
ZIP/Postal Code
92617
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Petra Wilder-Smith, DDS, PhD
Phone
949-824-7632
Email
pwsmith@hs.uci.edu
First Name & Middle Initial & Last Name & Degree
Hanna Kim, MA
Phone
949-824-9265
Email
hhkim3@uci.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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6947992
Citation
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Citation
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Citation
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Citation
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Imaging-based Assessment of Oral Biofilm and Gingival Health

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