Trial of Toothpaste to Reduce Plaque and Inflammation

• Sponsor: University of Illinois at Chicago (Other)
• Overall Status: Completed
• CT.gov ID: NCT02666508
• Collaborator: Florida Atlantic University (Other)
• Enrollment: 61
• Location: 1
• Arms: 2
• Actual Duration (Months): 11.7
• Patients Per Site Per Month: 5.2

Study Details

Study Description

Brief Summary

Dental plaque causes caries and periodontal disease and data are sparse about toothpaste and plaque removal. Inflammation, caused by dental plaque, is a risk factor for cardiovascular disease. (CVD) The availability of (Plaque HD (TM), a plaque identifying toothpaste with targetol technology (TM)), afforded the unique opportunity to test whether there were statistically significant and clinically important reductions in plaque and inflammation in a randomized trial of apparently healthy individuals.

Condition or Disease	Intervention/Treatment	Phase
Plaque; Inflammation	Other: Plaque identifying toothpaste; Other: Non-plaque identifying toothpaste	N/A

Detailed Description

The protocol was approved by the Institutional Review Board of the University of Illinois and the trial was posted on ClinicalTrials.gov. We screened all potentially eligible subjects from the Medical District of the University of Illinois which includes the Colleges of Dentistry, Medicine, Public Health and Pharmacy.

All willing and eligible subjects signed informed consent forms and were instructed to refrain from brushing or flossing teeth, using any oral hygiene aids (such as mouthwash or chewing gum) the evening prior to and the morning of the data collection appointment. All subjects were be asked to complete the following procedures:

1. Rinse for 10 seconds with 25 mL of phosphate buffer

2. Rinse for 1 minute with 5.0 mL of 1240-ppm fluorescein in phosphate buffer

3. Rinse 3 times (for 10 seconds) with 25mL of phosphate buffer

4. Be positioned on a tripod chin rest 15 inches in front of the camera, retraction placed and intraoral images captured under UV LED light imaging.

5. Provide a blood sample for hs-CRP.

6. Use a 30 day supply of their assigned toothpaste and were instructed to follow the same brushing protocol for the entire month as well as a brushing diary to assist in recording daily participation.

The identical procedures were repeated at the 30 day follow up visit.. In addition, the Plaque HD group was instructed to brush in front of a mirror for 1 minute and to concentrate on removing all visible dye. The placebo group was asked to brush their teeth for 1 minute in front of a mirror, using the provided manual toothbrush.

.

Study Design

• Study Type: Interventional
• Actual Enrollment: 61 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: A Randomized Trial of Plaque Identifying Toothpaste on Reduction of Plaque and Inflammation
• Actual Study Start Date: Sep 1, 2015
• Actual Primary Completion Date: Apr 1, 2016
• Actual Study Completion Date: Aug 22, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Plaque identifying toothpaste A 30 day supply of daily syringes containing a plaque identifying toothpaste with targetol	Other: Plaque identifying toothpaste; Plaque identifying toothpaste with targetol
Active Comparator: Non-plaque identifying toothpaste A 30 day supply of daily syringes containing an identical non plaque identifying toothpaste without targetol	Other: Non-plaque identifying toothpaste; Non-plaque identifying toothpaste without targetol

Outcome Measures

Primary Outcome Measures

1. Change in Oral Plaque [Baseline to 30 - 60 days post baseline]

   Measure description "percentage" refers to the change in plaque percentage from the baseline to the follow-up visit. The follow-up visit occurred between 30 and 60 days post baseline.

2. Change in Hs-CRP Serum Level [Baseline to 30 - 60 days post baseline]

   Measure description "mg/L" refers to the change in hs-CRP per mg/L from the baseline to the follow-up visit. The follow-up visit occurred between 30 and 60 days post baseline.

Secondary Outcome Measures

1. Change in Oral Plaque - PSS Analysis [Baseline to 30-60 days post]

   Measure description "percentage" refers to the change in plaque percentage from the baseline to the follow-up visit. The follow-up visit occurred between 30 and 60 days post baseline for the Pre-Specified Subgroup (PSS).

2. Change in Inflammation - PSS Analysis [Baseline to 30-60 days post]

   Measure description "mg/L" refers to the change in hs-CRP per mg/L from the baseline to the follow-up visit. The follow-up visit occurred between 30 and 60 days post baseline. -PSS analysis

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

The inclusion criteria were as follows:

• Apparently healthy men and women age 19-45 with no history of CVD

• All 12 anterior teeth present (canine to canine in both upper and lower arches)

• English speaking

• Ability to commit to two 30 minute appointments These appointment must be 1 month apart)

Exclusion Criteria:

• • Student, faculty or staff with a clinical role at the University of Illinois College of Dentistry

• Individuals taking aspirin, other non-steroidal anti-inflammatory drugs or statins.

• Women who are pregnant or nursing

• Women taking birth control pills or using any hormone released birth control device

• Women on hormone replacement therapy

• Individuals who have taken antibiotics within two weeks of data collection appointment

• Individuals experiencing xerostomia

• Individuals who have experienced an illness, infection or tissue injury within two weeks of data collection appointment

• Individuals with arthritis, lupus or other chronic inflammatory conditions or syndromes

• Individuals with allergies to dyes or over the counter products

• Individuals who have missing anterior teeth, fixed or removable appliances or visible decay or staining in the anterior region (canine to canine in both upper and lower arches)

• Individuals whom have had a dental prophylaxis within 30 days of the data collection visit

• Individuals who have had a new restoration placed (anywhere in the oral cavity) within 30 days of the data collection visit

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UIC Clinical Research Center	Chicago	Illinois	United States	60612

Sponsors and Collaborators

• University of Illinois at Chicago
• Florida Atlantic University

Investigators

• Principal Investigator: Kimberly Fasula, MS, University of Illinois at Chicago

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• The World Health Organization. Cardiovascular Diseases (CVDs)
• American Heart Association. Heart and Stroke Statistics.
• Relationship between serum antibody titres to porphyromonas gingivalis and hs-CRP levels as inflammatory markers of periodontitis.
• Hs-CRP: The test | high-sensitivity C-reactive protein; hs-CRP test: High-sensitivity C-reactive protein | lab tests online.
• HSRIC: Grants, funding and fellowships.

Publications

• Al-Anezi SA, Harradine NW. Quantifying plaque during orthodontic treatment:. Angle Orthod. 2012 Jul;82(4):748-53. doi: 10.2319/050111-312.1. Epub 2011 Nov 1. Review.
• Anderson KM, Odell PM, Wilson PW, Kannel WB. Cardiovascular disease risk profiles. Am Heart J. 1991 Jan;121(1 Pt 2):293-8.
• Anitha G, Nagaraj M, Jayashree A. Comparative evaluation of levels of C-reactive protein and PMN in periodontitis patients related to cardiovascular disease. J Indian Soc Periodontol. 2013 May;17(3):330-2. doi: 10.4103/0972-124X.115657.
• Bokhari SA, Khan AA, Butt AK, Azhar M, Hanif M, Izhar M, Tatakis DN. Non-surgical periodontal therapy reduces coronary heart disease risk markers: a randomized controlled trial. J Clin Periodontol. 2012 Nov;39(11):1065-74. doi: 10.1111/j.1600-051X.2012.01942.x. Epub 2012 Sep 11.
• Carter K, Landini G, Walmsley AD. Automated quantification of dental plaque accumulation using digital imaging. J Dent. 2004 Nov;32(8):623-8.
• Chen T, Yu WH, Izard J, Baranova OV, Lakshmanan A, Dewhirst FE. The Human Oral Microbiome Database: a web accessible resource for investigating oral microbe taxonomic and genomic information. Database (Oxford). 2010 Jul 6;2010:baq013. doi: 10.1093/database/baq013.
• Cusumano CA. Periodontal disease associated with an increased CRP in chronic hemodialysis patients. Rev Nefrol Dial Trans. 2013; 33:188-195.
• D'Aiuto F, Parkar M, Andreou G, Suvan J, Brett PM, Ready D, Tonetti MS. Periodontitis and systemic inflammation: control of the local infection is associated with a reduction in serum inflammatory markers. J Dent Res. 2004 Feb;83(2):156-60.
• Danesh J, Wheeler JG, Hirschfield GM, Eda S, Eiriksdottir G, Rumley A, Lowe GD, Pepys MB, Gudnason V. C-reactive protein and other circulating markers of inflammation in the prediction of coronary heart disease. N Engl J Med. 2004 Apr 1;350(14):1387-97.
• de Oliveira C, Watt R, Hamer M. Toothbrushing, inflammation, and risk of cardiovascular disease: results from Scottish Health Survey. BMJ. 2010 May 27;340:c2451. doi: 10.1136/bmj.c2451.
• Goyal L, Bey A, Gupta ND, Sharma VK. Comparative evaluation of serum C-reactive protein levels in chronic and aggressive periodontitis patients and association with periodontal disease severity. Contemp Clin Dent. 2014 Oct;5(4):484-8. doi: 10.4103/0976-237X.142816.
• Gundala R, Chava VK. Effect of lifestyle, education and socioeconomic status on periodontal health. Contemp Clin Dent. 2010 Jan;1(1):23-6. doi: 10.4103/0976-237X.62516.
• Harnacke D, Winterfeld T, Erhardt J, Schlueter N, Ganss C, Margraf-Stiksrud J, Deinzer R. What is the best predictor for oral cleanliness after brushing? Results from an observational cohort study. J Periodontol. 2015 Jan;86(1):101-7. doi: 10.1902/jop.2014.140152.
• Kajikawa M, Nakashima A, Maruhashi T, Iwamoto Y, Iwamoto A, Matsumoto T, Hidaka T, Kihara Y, Chayama K, Goto C, Taguchi A, Noma K, Higashi Y. Poor oral health, that is, decreased frequency of tooth brushing, is associated with endothelial dysfunction. Circ J. 2014;78(4):950-4. Epub 2014 Feb 5.
• Kholy KE, Genco RJ, Van Dyke TE. Oral infections and cardiovascular disease. Trends Endocrinol Metab. 2015 Jun;26(6):315-21. doi: 10.1016/j.tem.2015.03.001. Epub 2015 Apr 16. Review.
• Kim HC, Yang DM, Lee CM, Jin W, Nam DH, Song JY, Kim JY. Acute appendicitis: relationships between CT-determined severities and serum white blood cell counts and C-reactive protein levels. Br J Radiol. 2011 Dec;84(1008):1115-20. doi: 10.1259/bjr/47699219. Epub 2010 Dec 1.
• Kim YH, Lee SY. Identification of non-streptococcal organisms from human dental plaque grown on the Streptococcus-selective medium mitis-salivarius agar. Arch Oral Biol. 2015 Feb;60(2):267-71. doi: 10.1016/j.archoralbio.2014.11.002. Epub 2014 Nov 8.
• Kumar KR, Ranganath V, Naik R, Banu S, Nichani AS. Assessment of high-sensitivity C-reactive protein and lipid levels in healthy adults and patients with coronary artery disease, with and without periodontitis--a cross-sectional study. J Periodontal Res. 2014 Dec;49(6):836-44. doi: 10.1111/jre.12172. Epub 2014 Mar 12.
• Loos BG, Craandijk J, Hoek FJ, Wertheim-van Dillen PM, van der Velden U. Elevation of systemic markers related to cardiovascular diseases in the peripheral blood of periodontitis patients. J Periodontol. 2000 Oct;71(10):1528-34.
• Loos BG. Systemic markers of inflammation in periodontitis. J Periodontol. 2005 Nov;76(11 Suppl):2106-15. Review.
• Mani A, Vadvadgi V, Anarthe R, Saini R, Mani S. A clinical study on Dental Air Force Cleaning System on adult chronic periodontits and its assessment to C-reactive protein levels. Int J Exp Dent Sci. 2012; 1:14-18.
• Mbawalla HS, Masalu JR, Astrøm AN. Socio-demographic and behavioural correlates of oral hygiene status and oral health related quality of life, the Limpopo-Arusha school health project (LASH): a cross-sectional study. BMC Pediatr. 2010 Nov 30;10:87. doi: 10.1186/1471-2431-10-87.
• Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, de Ferranti S, Després JP, Fullerton HJ, Howard VJ, Huffman MD, Judd SE, Kissela BM, Lackland DT, Lichtman JH, Lisabeth LD, Liu S, Mackey RH, Matchar DB, McGuire DK, Mohler ER 3rd, Moy CS, Muntner P, Mussolino ME, Nasir K, Neumar RW, Nichol G, Palaniappan L, Pandey DK, Reeves MJ, Rodriguez CJ, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Willey JZ, Woo D, Yeh RW, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2015 update: a report from the American Heart Association. Circulation. 2015 Jan 27;131(4):e29-322. doi: 10.1161/CIR.0000000000000152. Epub 2014 Dec 17. Erratum in: Circulation. 2015 Jun 16;131(24):e535. Circulation. 2016 Feb 23;133(8):e417.
• Noack B, Genco RJ, Trevisan M, Grossi S, Zambon JJ, De Nardin E. Periodontal infections contribute to elevated systemic C-reactive protein level. J Periodontol. 2001 Sep;72(9):1221-7.
• Pejcic A, Kesic LJ, Milasin J. C-reactive protein as a systemic marker of inflammation in periodontitis. Eur J Clin Microbiol Infect Dis. 2011 Mar;30(3):407-14. doi: 10.1007/s10096-010-1101-1. Epub 2010 Nov 6.
• Pepys MB, Hirschfield GM. C-reactive protein: a critical update. J Clin Invest. 2003 Jun;111(12):1805-12. Review. Erratum in: J Clin Invest. 2003 Jul;112(2):299.
• Persson GR, Persson RE. Cardiovascular disease and periodontitis: an update on the associations and risk. J Clin Periodontol. 2008 Sep;35(8 Suppl):362-79. doi: 10.1111/j.1600-051X.2008.01281.x. Review.
• Ramamoorthy RD, Nallasamy V, Reddy R, Esther N, Maruthappan Y. A review of C-reactive protein: A diagnostic indicator in periodontal medicine. J Pharm Bioallied Sci. 2012 Aug;4(Suppl 2):S422-6. doi: 10.4103/0975-7406.100318.
• Ridker PM, Cushman M, Stampfer MJ, Tracy RP, Hennekens CH. Inflammation, aspirin, and the risk of cardiovascular disease in apparently healthy men. N Engl J Med. 1997 Apr 3;336(14):973-9. Erratum in: N Engl J Med 1997 Jul 31;337(5):356.
• Ridker PM, Hennekens CH, Buring JE, Rifai N. C-reactive protein and other markers of inflammation in the prediction of cardiovascular disease in women. N Engl J Med. 2000 Mar 23;342(12):836-43.
• Short VL, Ivory-Walls T, Smith L, Loustalot F. The Mississippi Delta Cardiovascular Health Examination Survey: Study Design and Methods. Epidemiol Res Int. 2014 Jan 1;2014(Article 499 861461):861461.
• Stevens K, Belavsky B, Evans CA, Viana MG, Wu C. Evaluation of plaque removal efficacy of a novel dye-containing toothpaste: a clinical trial. Int J Dentistry Oral Sci. 2016; 3(1):185-189
• Tonetti MS. Periodontitis and risk for atherosclerosis: an update on intervention trials. J Clin Periodontol. 2009 Jul;36 Suppl 10:15-9. doi: 10.1111/j.1600-051X.2009.01417.x. Review.
• Van Dyke TE, van Winkelhoff AJ. Infection and inflammatory mechanisms. J Clin Periodontol. 2013 Apr;40 Suppl 14:S1-7. doi: 10.1111/jcpe.12088. Review.
• Zijnge V, van Leeuwen MB, Degener JE, Abbas F, Thurnheer T, Gmür R, Harmsen HJ. Oral biofilm architecture on natural teeth. PLoS One. 2010 Feb 24;5(2):e9321. doi: 10.1371/journal.pone.0009321.

• Responsible Party: Kim Fasula, Director of Clinic Operations & Clinical Instructor, College of Dentistry, University of Illinois at Chicago
• ClinicalTrials.gov Identifier: NCT02666508
• Other Study ID Numbers: 2015-0620
• First Posted: Jan 28, 2016
• Last Update Posted: Jan 14, 2021
• Last Verified: Jan 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Kim Fasula, Director of Clinic Operations & Clinical Instructor, College of Dentistry, University of Illinois at Chicago: plaque identifying toothpaste; plaque score; C-reactive protein
• Additional relevant MeSH terms: Inflammation

Study Results

Participant Flow

Recruitment Details	Sixty-one apparently healthy subjects aged 19-45 were recruited from the University of Illinois at Chicago campus and surrounding Medical District. Recruitment began in August 2015.
Pre-assignment Detail	This study did not include pre-assignment criteria other than inclusion/exclusion criteria that determined study eligibility. Only 5 of the 66 screened subjects did not meet eligibility for participation. Qualified subjects were then assigned, by computer randomization in Crosspad©, a subject identification number and randomized.

Arm/Group Title	Plaque Identifying Toothpaste	Non-plaque Identifying Toothpaste
Arm/Group Description	A 30 day supply of dosed syringes containing a plaque identifying toothpaste. Toothpaste was dosed in 2 ml syringes and subjects were instructed to use half (1ml) in the morning and half (1ml) in the evening.	A 30 day supply of dosed syringes containing an identical non-plaque identifying toothpaste. Toothpaste was dosed in 2 ml syringes and subjects were instructed to use half (1ml) in the morning and half (1ml) in the evening.
Period Title: Overall Study
STARTED	31	30
COMPLETED	31	30
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Plaque Identifying Toothpaste	Non-plaque Identifying Toothpaste	Total
Arm/Group Description	A 30 day supply of dosed syringes containing a plaque identifying toothpaste Plaque identifying toothpaste: Plaque identifying toothpaste Toothpaste is dosed in 2 ml syringes and subjects were instructed to use half (1ml) in the morning and half (1ml) in the evening.	A 30 day supply of dosed syringes containing an identical non-plaque identifying toothpaste Non-plaque identifying toothpaste: Non-plaque identifying toothpaste Toothpaste is dosed in 2 ml syringes and subjects were instructed to use half (1ml) in the morning and half (1ml) in the evening.	Total of all reporting groups
Overall Participants	31	30	61
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	31 100%	30 100%	61 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	16 51.6%	18 60%	34 55.7%
Male	15 48.4%	12 40%	27 44.3%
Race/Ethnicity, Customized (Count of Participants)
African American	6 19.4%	5 16.7%	11 18%
Asian	13 41.9%	10 33.3%	23 37.7%
Caucasian	8 25.8%	8 26.7%	16 26.2%
Hispanic	4 12.9%	7 23.3%	11 18%
Other	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
United States	31 100%	30 100%	61 100%
Digital Plaque Image Analysis (DPIA) (log(Percentage)) [Geometric Mean (Standard Deviation) ]
Geometric Mean (Standard Deviation) [log(Percentage)]	1.69 (1.21)	1.06 (1.58)	1.38 (1.43)
High-sensitivity C-Reactive Protein (hs-CRP) (log(mg/L)) [Geometric Mean (Standard Deviation) ]
Geometric Mean (Standard Deviation) [log(mg/L)]	0.10 (1.30)	0.24 (1.17)	0.17 (1.23)

Outcome Measures

1. Primary Outcome

Title	Change in Oral Plaque
Description	Measure description "percentage" refers to the change in plaque percentage from the baseline to the follow-up visit. The follow-up visit occurred between 30 and 60 days post baseline.
Time Frame	Baseline to 30 - 60 days post baseline

Outcome Measure Data

Analysis Population Description

Primary analysis group definition was based on the Intent-to-Treat (ITT) principle.

Arm/Group Title	Plaque Identifying Toothpaste	Non-plaque Identifying Toothpaste
Arm/Group Description	A 30 day supply of daily syringes containing a plaque identifying toothpaste with targetol Plaque identifying toothpaste: Plaque identifying toothpaste with targetol	A 30 day supply of daily syringes containing an identical non plaque identifying toothpaste without targetol Non-plaque identifying toothpaste: Non-plaque identifying toothpaste without targetol
Measure Participants	31	30
Geometric Mean (95% Confidence Interval) [log(percentage)]	-1.05	-0.03

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Plaque Identifying Toothpaste, Non-plaque Identifying Toothpaste
	Comments
	Type of Statistical Test	Other
	Comments	Test conducted was a test of difference between plaque identifying toothpaste and non-plaque identifying toothpaste for change in DPIA from pre to post.
Statistical Test of Hypothesis	p-Value	0.001
	Comments
	Method	Repeated Measures ANOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-1.02
	Confidence Interval	(2-Sided) 95%; -1.60 to -0.44
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	Change in Hs-CRP Serum Level
Description	Measure description "mg/L" refers to the change in hs-CRP per mg/L from the baseline to the follow-up visit. The follow-up visit occurred between 30 and 60 days post baseline.
Time Frame	Baseline to 30 - 60 days post baseline

Outcome Measure Data

Analysis Population Description

Primary analysis group definition was based on the Intent-to-Treat (ITT) principle.

Arm/Group Title	Plaque Identifying Toothpaste	Non-plaque Identifying Toothpaste
Arm/Group Description	A 30 day supply of daily syringes containing a plaque identifying toothpaste with targetol Plaque identifying toothpaste: Plaque identifying toothpaste with targetol	A 30 day supply of daily syringes containing an identical non plaque identifying toothpaste without targetol Non-plaque identifying toothpaste: Non-plaque identifying toothpaste without targetol
Measure Participants	31	30
Geometric Mean (95% Confidence Interval) [log(mg/L)]	0.04	0.22

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Plaque Identifying Toothpaste, Non-plaque Identifying Toothpaste
	Comments
	Type of Statistical Test	Other
	Comments	Test conducted was a test of the difference between plaque identifying toothpaste and non-plaque identifying toothpaste for change in hsCRP
Statistical Test of Hypothesis	p-Value	0.459
	Comments
	Method	Repeated Measures ANOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.18
	Confidence Interval	(2-Sided) 95%; -0.69 to 0.32
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Change in Oral Plaque - PSS Analysis
Description	Measure description "percentage" refers to the change in plaque percentage from the baseline to the follow-up visit. The follow-up visit occurred between 30 and 60 days post baseline for the Pre-Specified Subgroup (PSS).
Time Frame	Baseline to 30-60 days post

Outcome Measure Data

Analysis Population Description

Secondary analysis group definition was based on Pre-Specified Subgroup of subjects such that 30 <= follow-up <= 60 days

Arm/Group Title	Plaque Identifying Toothpaste	Non-plaque Identifying Toothpaste
Arm/Group Description	A 30 day supply of daily syringes containing a plaque identifying toothpaste with targetol Plaque identifying toothpaste: Plaque identifying toothpaste with targetol With follow-up between 30-60 days.	A 30 day supply of daily syringes containing an identical non plaque identifying toothpaste without targetol Non-plaque identifying toothpaste: Non-plaque identifying toothpaste without targetol With follow-up between 30-60 days.
Measure Participants	31	29
Geometric Mean (95% Confidence Interval) [log(percentage)]	-1.05	-0.10

4. Secondary Outcome

Title	Change in Inflammation - PSS Analysis
Description	Measure description "mg/L" refers to the change in hs-CRP per mg/L from the baseline to the follow-up visit. The follow-up visit occurred between 30 and 60 days post baseline. -PSS analysis
Time Frame	Baseline to 30-60 days post

Outcome Measure Data

Analysis Population Description

Secondary analysis group definition for hs-CRP was based on a Pre-Specified Subgroup which had 0.5 <= baseline hs-CRP <= 10.0 and 30 <= follow-up <= 60 days

Arm/Group Title	Plaque Identifying Toothpaste	Non-plaque Identifying Toothpaste
Arm/Group Description	A 30 day supply of daily syringes containing a plaque identifying toothpaste with targetol Plaque identifying toothpaste: Plaque identifying toothpaste with targetol With baseline hs-CRP between 0.5 and 10 mg/L and follow-up between 30-60 days.	A 30 day supply of daily syringes containing an identical non plaque identifying toothpaste without targetol Non-plaque identifying toothpaste: Non-plaque identifying toothpaste without targetol With baseline hs-CRP between 0.5 and 10 mg/L and follow-up between 30-60 days.
Measure Participants	19	19
Geometric Mean (95% Confidence Interval) [log(mg/L)]	-0.40	0.14

Adverse Events

Time Frame	Baseline to follow-up (30 - 60 days post baseline)
Adverse Event Reporting Description	Adverse events were identified as: All-Cause Mortality Serious Adverse Events Other (Not Including Serious) Adverse Events Subjects were instructed to discontinue toothpaste use and contact PI if they experienced any adverse reactions to the product. Subjects were instructed to call 911 if any serious reactions occurred. Subjects were asked at follow-up visit and post-study debriefing if any adverse events occurred. No adverse events were reported.
Arm/Group Title	Plaque Identifying Toothpaste		Non-plaque Identifying Toothpaste
Arm/Group Description	A 30 day supply of dosed syringes containing a plaque identifying toothpaste Plaque identifying toothpaste: Plaque identifying toothpaste		A 30 day supply of dosed syringes containing an identical non plaque identifying toothpaste Non-plaque identifying toothpaste: Non-plaque identifying toothpaste
All Cause Mortality
	Plaque Identifying Toothpaste		Non-plaque Identifying Toothpaste
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/31 (0%)		0/30 (0%)
Serious Adverse Events
	Plaque Identifying Toothpaste		Non-plaque Identifying Toothpaste
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/31 (0%)		0/30 (0%)
Other (Not Including Serious) Adverse Events
	Plaque Identifying Toothpaste		Non-plaque Identifying Toothpaste
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/31 (0%)		0/30 (0%)

Limitations/Caveats

Funding limited the study to a small number of subjects. Funding also limited options to compensate subject as a method to pre-select subjects with elevated hs-CRP.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.