Plaque, DentalNCT05470023
Imaging-based Assessment of Oral Biofilm and Gingival Health
A study testing OTC Toothpastes or Mouthrinses in people with Plaque, Dental and Gingivitis, run by University of California, Irvine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Plaque, Dental, Gingivitis
- What is being tested?
- OTC Toothpastes or Mouthrinses
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 275 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2022to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 18 years of age or older
- In good general health
Who cannot join
- History of allergy or intolerance of oral hygiene products such as toothpastes and mouthrinses
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Beckman Laser Institute and Medical Clinic
Irvine, California, 92617
Petra Wilder-Smith, DDS, PhD, 949-824-7632, pwsmith@hs.uci.edu
Nicole Wakida, PhD, 949-824-4360, nwakida@uci.edu
About this study
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.
Read the 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.
- Conditions
- Plaque, Dental, Gingivitis
- Being tested
- OTC Toothpastes or Mouthrinses
- Medical subject headings
- Dental Plaque, Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OTC Toothpastes or MouthrinsesOther
OTC Toothpastes or mouthrinses used according to standard of care
| Study group | Role | What they receive |
|---|---|---|
| Brushing with LivFresh Dental Gel | Active comparator | 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. Receives: Other: OTC Toothpastes or Mouthrinses |
| Brushing with LivFree Dental Gel | Active comparator | 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. Receives: Other: OTC Toothpastes or Mouthrinses |
| Brushing with AIM Dental Gel | Active comparator | 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. Receives: Other: OTC Toothpastes or Mouthrinses |
| Brushing with Crest Prohealth Dental Gel | Active comparator | 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. Receives: Other: OTC Toothpastes or Mouthrinses |
| Brushing with Parodontax Dental Gel | Active comparator | 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. Receives: Other: OTC Toothpastes or Mouthrinses |
| Brushing with Colgate Total Dental Gel | Active comparator | 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. Receives: Other: OTC Toothpastes or Mouthrinses |
| Rinsing with Lumineux or Listerine Mouthwashes | Active comparator | 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. Receives: Other: OTC Toothpastes or Mouthrinses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plaque level at Week 1
Oral plaque will be measured using the gold standard plaque index (0-5; 0-best, 5 worst).
Measured: 1 week
Plaque level at Month 1
Oral plaque will be measured using the gold standard plaque index (0-5; 0-best, 5 worst).
Measured: 1 month
Plaque level at Month 3
Oral plaque will be measured using the gold standard plaque index (0-5; 0-best, 5 worst).
Measured: 3 months
Plaque level at Month 6
Oral plaque will be measured using the gold standard plaque index (0-5; 0-best, 5 worst).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2022
- Study start1 Sep 2022
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Plaque, DentalStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be randomized to different treatments.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 275 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Petra E. Wilder-Smith, University of California, Irvine
- Investigators
- Dr. Petra Wilder-Smith, Principal investigator, Beckman Laser Institute University of California Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05470023
- Sponsor's protocol ID
- 881
- Status last verified
- Dec 2025
- First submitted
- 15 Jul 2022
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Axelsson P, Lindhe J. The significance of maintenance care in the treatment of periodontal disease. J Clin Periodontol. 1981 Aug;8(4):281-94. doi: 10.1111/j.1600-051x.1981.tb02039.x. No abstract available.
PubMed 6947992Baek JH, Krasieva T, Tang S, Ahn Y, Kim CS, Vu D, Chen Z, Wilder-Smith P. Optical approach to the salivary pellicle. J Biomed Opt. 2009 Jul-Aug;14(4):044001. doi: 10.1117/1.3158994.
PubMed 19725713Colston BW Jr, Everett MJ, Da Silva LB, Otis LL, Stroeve P, Nathel H. Imaging of hard- and soft-tissue structure in the oral cavity by optical coherence tomography. Appl Opt. 1998 Jun 1;37(16):3582-5. doi: 10.1364/ao.37.003582.
PubMed 18273327Eke PI, Dye BA, Wei L, Thornton-Evans GO, Genco RJ; CDC Periodontal Disease Surveillance workgroup: James Beck (University of North Carolina, Chapel Hill, USA), Gordon Douglass (Past President, American Academy of Periodontology), Roy Page (University of Washin. Prevalence of periodontitis in adults in the United States: 2009 and 2010. J Dent Res. 2012 Oct;91(10):914-20. doi: 10.1177/0022034512457373. Epub 2012 Aug 30.
PubMed 22935673Haffajee AD, Socransky SS. Microbial etiological agents of destructive periodontal diseases. Periodontol 2000. 1994 Jun;5:78-111. doi: 10.1111/j.1600-0757.1994.tb00020.x. No abstract available.
PubMed 9673164Llena-Puy C. The role of saliva in maintaining oral health and as an aid to diagnosis. Med Oral Patol Oral Cir Bucal. 2006 Aug;11(5):E449-55. English, Spanish.
PubMed 16878065LOE H, SILNESS J. PERIODONTAL DISEASE IN PREGNANCY. I. PREVALENCE AND SEVERITY. Acta Odontol Scand. 1963 Dec;21:533-51. doi: 10.3109/00016356309011240. No abstract available.
PubMed 14121956Madlena M, Banoczy J, Gotz G, Marton S, Kaan M Jr, Nagy G. Effects of amine and stannous fluorides on plaque accumulation and gingival health in orthodontic patients treated with fixed appliances: a pilot study. Oral Health Dent Manag. 2012 Jun;11(2):57-61.
PubMed 22692271Morris AJ, Steele J, White DA. The oral cleanliness and periodontal health of UK adults in 1998. Br Dent J. 2001 Aug 25;191(4):186-92. doi: 10.1038/sj.bdj.4801135.
PubMed 11551090Nogueira-Filho GR, Toledo S, Cury JA. Effect of 3 dentifrices containing triclosan and various additives. An experimental gingivitis study. J Clin Periodontol. 2000 Jul;27(7):494-8. doi: 10.1034/j.1600-051x.2000.027007494.x.
PubMed 10914890Theilade E, Wright WH, Jensen SB, Loe H. Experimental gingivitis in man. II. A longitudinal clinical and bacteriological investigation. J Periodontal Res. 1966;1:1-13. doi: 10.1111/j.1600-0765.1966.tb01842.x. No abstract available.
PubMed 4224181Turesky S, Gilmore ND, Glickman I. Reduced plaque formation by the chloromethyl analogue of victamine C. J Periodontol. 1970 Jan;41(1):41-3. doi: 10.1902/jop.1970.41.41.41. No abstract available.
PubMed 5264376van der Weijden GA, Hioe KP. A systematic review of the effectiveness of self-performed mechanical plaque removal in adults with gingivitis using a manual toothbrush. J Clin Periodontol. 2005;32 Suppl 6:214-28. doi: 10.1111/j.1600-051X.2005.00795.x.
PubMed 16128840Yates R, Jenkins S, Newcombe R, Wade W, Moran J, Addy M. A 6-month home usage trial of a 1% chlorhexidine toothpaste (1). Effects on plaque, gingivitis, calculus and toothstaining. J Clin Periodontol. 1993 Feb;20(2):130-8. doi: 10.1111/j.1600-051x.1993.tb00327.x.
PubMed 8436632
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging-based Assessment of Oral Biofilm and Gingival Health
- ClinicalTrials.gov ID
- NCT05470023
- Acronym / sponsor ID
- 881
- Conditions
- Plaque, Dental, Gingivitis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 275 participants (estimated)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 22 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
- Model description
- Subjects will be randomized to different treatments.
| Arm | Type | Receives |
|---|---|---|
| Brushing with LivFresh Dental Gel | Active comparator | Other: OTC Toothpastes or MouthrinsesSubjects 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 LivFree Dental Gel | Active comparator | Other: OTC Toothpastes or MouthrinsesSubjects 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 | Active comparator | Other: OTC Toothpastes or MouthrinsesSubjects 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. |
| Brushing with Crest Prohealth Dental Gel | Active comparator | Other: OTC Toothpastes or MouthrinsesSubjects 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 Parodontax Dental Gel | Active comparator | Other: OTC Toothpastes or MouthrinsesSubjects 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. |
| Brushing with Colgate Total Dental Gel | Active comparator | Other: OTC Toothpastes or MouthrinsesSubjects 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. |
| Rinsing with Lumineux or Listerine Mouthwashes | Active comparator | Other: OTC Toothpastes or MouthrinsesSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- At least 18 years of age or older
- In good general health
Key exclusion criteria (1 listed)
- History of allergy or intolerance of oral hygiene products such as toothpastes and mouthrinses
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OTC Toothpastes or MouthrinsesOTC Toothpastes or mouthrinses used according to standard of care | Other | Brushing with AIM Dental Gel, Brushing with Colgate Total Dental Gel, Brushing with Crest Prohealth Dental Gel, Brushing with LivFree Dental Gel, Brushing with LivFresh Dental Gel, Brushing with Parodontax Dental Gel, Rinsing with Lumineux or Listerine Mouthwashes |
Primary outcome
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Background: PubMed 6947992Axelsson P, Lindhe J. The significance of maintenance care in the treatment of periodontal disease. J Clin Periodontol. 1981 Aug;8(4):281-94. doi: 10.1111/j.1600-051x.1981.tb02039.x. No abstract available.
- Background: PubMed 19725713Baek JH, Krasieva T, Tang S, Ahn Y, Kim CS, Vu D, Chen Z, Wilder-Smith P. Optical approach to the salivary pellicle. J Biomed Opt. 2009 Jul-Aug;14(4):044001. doi: 10.1117/1.3158994.
- Background: PubMed 18273327Colston BW Jr, Everett MJ, Da Silva LB, Otis LL, Stroeve P, Nathel H. Imaging of hard- and soft-tissue structure in the oral cavity by optical coherence tomography. Appl Opt. 1998 Jun 1;37(16):3582-5. doi: 10.1364/ao.37.003582.
- Background: PubMed 22935673Eke PI, Dye BA, Wei L, Thornton-Evans GO, Genco RJ; CDC Periodontal Disease Surveillance workgroup: James Beck (University of North Carolina, Chapel Hill, USA), Gordon Douglass (Past President, American Academy of Periodontology), Roy Page (University of Washin. Prevalence of periodontitis in adults in the United States: 2009 and 2010. J Dent Res. 2012 Oct;91(10):914-20. doi: 10.1177/0022034512457373. Epub 2012 Aug 30.
- Background: PubMed 9673164Haffajee AD, Socransky SS. Microbial etiological agents of destructive periodontal diseases. Periodontol 2000. 1994 Jun;5:78-111. doi: 10.1111/j.1600-0757.1994.tb00020.x. No abstract available.
- Background: PubMed 16878065Llena-Puy C. The role of saliva in maintaining oral health and as an aid to diagnosis. Med Oral Patol Oral Cir Bucal. 2006 Aug;11(5):E449-55. English, Spanish.
- Background: PubMed 14121956LOE H, SILNESS J. PERIODONTAL DISEASE IN PREGNANCY. I. PREVALENCE AND SEVERITY. Acta Odontol Scand. 1963 Dec;21:533-51. doi: 10.3109/00016356309011240. No abstract available.
- Background: PubMed 22692271Madlena M, Banoczy J, Gotz G, Marton S, Kaan M Jr, Nagy G. Effects of amine and stannous fluorides on plaque accumulation and gingival health in orthodontic patients treated with fixed appliances: a pilot study. Oral Health Dent Manag. 2012 Jun;11(2):57-61.
- Background: PubMed 11551090Morris AJ, Steele J, White DA. The oral cleanliness and periodontal health of UK adults in 1998. Br Dent J. 2001 Aug 25;191(4):186-92. doi: 10.1038/sj.bdj.4801135.
- Background: PubMed 10914890Nogueira-Filho GR, Toledo S, Cury JA. Effect of 3 dentifrices containing triclosan and various additives. An experimental gingivitis study. J Clin Periodontol. 2000 Jul;27(7):494-8. doi: 10.1034/j.1600-051x.2000.027007494.x.
- Background: PubMed 4224181Theilade E, Wright WH, Jensen SB, Loe H. Experimental gingivitis in man. II. A longitudinal clinical and bacteriological investigation. J Periodontal Res. 1966;1:1-13. doi: 10.1111/j.1600-0765.1966.tb01842.x. No abstract available.
- Background: PubMed 5264376Turesky S, Gilmore ND, Glickman I. Reduced plaque formation by the chloromethyl analogue of victamine C. J Periodontol. 1970 Jan;41(1):41-3. doi: 10.1902/jop.1970.41.41.41. No abstract available.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr. Petra Wilder-Smith principal investigator
Beckman Laser Institute University of California Irvine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OTC Toothpastes or Mouthrinses in people with Plaque, Dental and Gingivitis, run by University of California, Irvine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Petra Wilder-Smith (949-824-7632, pwsmith@uci.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plaque level at Week 1 (time frame: 1 week). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05470023, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.