- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05470023
Imaging-based Assessment of Oral Biofilm and Gingival Health
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Dr. Petra Wilder-Smith
- Phone Number: 949-824-7632
- Email: pwsmith@uci.edu
Study Contact Backup
- Name: Nicole Wakida, PhD
- Phone Number: 949-824-4360
- Email: nwakida@uci.edu
Study Locations
-
-
California
-
Irvine, California, United States, 92617
- Recruiting
- Beckman Laser Institute and Medical Clinic
-
Contact:
- Petra Wilder-Smith, DDS, PhD
- Phone Number: 949-824-7632
- Email: pwsmith@hs.uci.edu
-
Contact:
- Nicole Wakida, PhD
- Phone Number: 949-824-4360
- Email: nwakida@uci.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- At least 18 years of age or older
- In good general health
Exclusion Criteria:
- History of allergy or intolerance of oral hygiene products such as toothpastes and mouthrinses
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / 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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
OTC Toothpastes or mouthrinses used according to standard of care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
1 week
|
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).
|
1 month
|
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).
|
3 months
|
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).
|
6 months
|
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).
|
1 week
|
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).
|
1 month
|
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).
|
3 months
|
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).
|
6 months
|
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).
|
1 week
|
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).
|
1 month
|
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).
|
3 months
|
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).
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dr. Petra Wilder-Smith, Beckman Laser Institute University of California Irvine
Publications and helpful links
General Publications
- LOE 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.
- Eke 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.
- Turesky 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.
- Theilade 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.
- 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.
- Baek 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.
- Colston 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.
- Haffajee 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.
- Llena-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.
- Madlena 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.
- Morris 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.
- Nogueira-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.
- van 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.
- Yates 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 881
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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