Imaging-based Assessment of Oral Biofilm and Gingival Health

Overview

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.

Interventions

• Other OTC Toothpastes or Mouthrinses
  OTC Toothpastes or mouthrinses used according to standard of care

Primary outcome measures

• Plaque level at Week 1 [Time frame: 1 week]
• Plaque level at Month 1 [Time frame: 1 month]
• Plaque level at Month 3 [Time frame: 3 months]
• Plaque level at Month 6 [Time frame: 6 months]
• Gingival health (gingival index) at Week 1 [Time frame: 1 week]
• Gingival health (gingival index) at Month 1 [Time frame: 1 month]
• Gingival health (gingival index) at Month 3 [Time frame: 3 months]
• Gingival health (gingival index) at Month 6 [Time frame: 6 months]
• Gingival health (sulcus bleeding index) at Week 1 [Time frame: 1 week]
• Gingival health (sulcus bleeding index) at Month 1 [Time frame: 1 month]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Prevention

Study locations

United States · 1 center

• Beckman Laser Institute and Medical Clinic — Irvine

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. PMID 6947992
• 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
• 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
• 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: 10.1177/0022034512457 PMID 22935673
• 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
• 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
• 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
• 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

Identifiers

NCT: NCT05470023 · 881

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗