Imaging-based Assessment of Oral Biofilm and Gingival Health

NCT05470023 | Recruiting

• 1 other identifier: 881
• Study Type: interventional
• Target: 275
• Locations: 1 country
• Sites: 1

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.

Conditions

Plaque, Dental; Gingivitis

Outcome Measures

Primary Outcomes (12)

• Plaque level at Week 1

  Oral plaque will be measured using the gold standard plaque index (0-5; 0-best, 5 worst).

  1 week

• Plaque level at Month 1

  Oral plaque will be measured using the gold standard plaque index (0-5; 0-best, 5 worst).

  1 month

• Plaque level at Month 3

  Oral plaque will be measured using the gold standard plaque index (0-5; 0-best, 5 worst).

  3 months

• Plaque level at Month 6

  Oral plaque will be measured using the gold standard plaque index (0-5; 0-best, 5 worst).

  6 months

• Gingival health (gingival index) at Week 1

  Gingival health will be measured using the gold standard gingival index (0-3; 0-best, 3 worst).

  1 week

• Gingival health (gingival index) at Month 1

  Gingival health will be measured using the gold standard gingival index (0-3; 0-best, 3 worst).

  1 month

• Gingival health (gingival index) at Month 3

  Gingival health will be measured using the gold standard gingival index (0-3; 0-best, 3 worst).

  3 months

• Gingival health (gingival index) at Month 6

  Gingival health will be measured using the gold standard gingival index (0-3; 0-best, 3 worst).

  6 months

• Gingival health (sulcus bleeding index) at Week 1

  Gingival health will be measured using the gold standard modified sulcus bleeding index (0-3; 0-best, 3 worst).

  1 week

• Gingival health (sulcus bleeding index) at Month 1

  Gingival health will be measured using the gold standard modified sulcus bleeding index (0-3; 0-best, 3 worst).

  1 month

• Gingival health (sulcus bleeding index) at Month 3

  Gingival health will be measured using the gold standard modified sulcus bleeding index (0-3; 0-best, 3 worst).

  3 months

• Gingival health (sulcus bleeding index) at Month 6

  Gingival health will be measured using the gold standard modified sulcus bleeding index (0-3; 0-best, 3 worst).

  6 months

Study Arms (7)

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.

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.

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.

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.

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.

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.

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.

Other: OTC Toothpastes or Mouthrinses

Interventions

OTC Toothpastes or Mouthrinses OTHER

OTC Toothpastes or mouthrinses used according to standard of care

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years of age or older
• In good general health

You may not qualify if:

• History of allergy or intolerance of oral hygiene products such as toothpastes and mouthrinses

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

Beckman Laser Institute and Medical Clinic

Irvine, California, 92617, United States

RECRUITING

Related Publications (14)

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  PMID: 6947992 BACKGROUND

• 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.

  PMID: 19725713 BACKGROUND

• 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.

  PMID: 18273327 BACKGROUND

• 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.

  PMID: 22935673 BACKGROUND

• 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.

  PMID: 9673164 BACKGROUND

• 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.

  PMID: 16878065 BACKGROUND

• 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.

  PMID: 14121956 BACKGROUND

• 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.

  PMID: 22692271 BACKGROUND

• 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.

  PMID: 11551090 BACKGROUND

• 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.

  PMID: 10914890 BACKGROUND

• 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.

  PMID: 4224181 BACKGROUND

• 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.

  PMID: 5264376 BACKGROUND

• 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.

  PMID: 16128840 BACKGROUND

• 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.

  PMID: 8436632 BACKGROUND

MeSH Terms

Conditions

Dental Plaque; Gingivitis

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases

Study Officials

• Dr. Petra Wilder-Smith

  Beckman Laser Institute University of California Irvine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Petra Wilder-Smith

CONTACT

949-824-7632; pwsmith@uci.edu

Nicole Wakida, PhD

CONTACT

949-824-4360; nwakida@uci.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: White tape over receptacle.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery and Director of Dentistry

Model Details: Subjects will be randomized to different treatments.

Study Record Dates

• First Submitted: July 15, 2022
• First Posted: July 22, 2022
• Study Start: September 1, 2022
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)