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Imaging-based Assessment of Oral Biofilm and Gingival Health

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05470023
Recruitment Status : Not yet recruiting
First Posted : July 22, 2022
Last Update Posted : July 22, 2022
Sponsor:
Information provided by (Responsible Party):
Petra E. Wilder-Smith, 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.


Condition or disease Intervention/treatment Phase
Plaque, Dental Gingivitis Other: OTC Toothpastes or Mouthrinses Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 275 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Subjects will be randomized to different treatments.
Masking: Double (Participant, Investigator)
Masking Description: White tape over receptacle.
Primary Purpose: Prevention
Official Title: Imaging-based Assessment of Oral Biofilm and Gingival Health
Estimated Study Start Date : September 1, 2022
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2025

Arm Intervention/treatment
Active Comparator: Brushing with LivFresh Dental Gel
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
OTC Toothpastes or mouthrinses used according to standard of care

Active Comparator: Brushing with LivFree Dental Gel
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
OTC Toothpastes or mouthrinses used according to standard of care

Active Comparator: Brushing with AIM Dental Gel
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
OTC Toothpastes or mouthrinses used according to standard of care

Active Comparator: Brushing with Crest Prohealth Dental Gel
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
OTC Toothpastes or mouthrinses used according to standard of care

Active Comparator: Brushing with Parodontax Dental Gel
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
OTC Toothpastes or mouthrinses used according to standard of care

Active Comparator: Brushing with Colgate Total Dental Gel
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
OTC Toothpastes or mouthrinses used according to standard of care

Active Comparator: Rinsing with Lumineux or Listerine Mouthwashes
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
OTC Toothpastes or mouthrinses used according to standard of care




Primary Outcome Measures :
  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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05470023


Contacts
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Contact: Dr. Petra Wilder-Smith 949-824-7632 pwsmith@uci.edu
Contact: Hanna Kim 949-824-2251 hhkim3@uci.edu

Sponsors and Collaborators
University of California, Irvine
Investigators
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Principal Investigator: Dr. Petra Wilder-Smith Beckman Laser Institute University of California Irvine
Publications:

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Responsible Party: Petra E. Wilder-Smith, Professor of Surgery and Director of Dentistry, University of California, Irvine
ClinicalTrials.gov Identifier: NCT05470023    
Other Study ID Numbers: 881
First Posted: July 22, 2022    Key Record Dates
Last Update Posted: July 22, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Gingivitis
Dental Plaque
Infections
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Dental Deposits
Tooth Diseases