PlaqueNCT02666508
Trial of Toothpaste to Reduce Plaque and Inflammation
A study testing Plaque identifying toothpaste and Non-plaque identifying toothpaste in people with Plaque and Inflammation, run by University of Illinois Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Plaque, Inflammation
- What is being tested?
- Plaque identifying toothpaste and Non-plaque identifying toothpaste
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2015to 22 Aug 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 19 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- • 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UIC Clinical Research Center
Chicago, Illinois, 60612
About this study
Official title: A Randomized Trial of Plaque Identifying Toothpaste on Reduction of Plaque and Inflammation
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.
Read the 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:
- Rinse for 10 seconds with 25 mL of phosphate buffer
- Rinse for 1 minute with 5.0 mL of 1240-ppm fluorescein in phosphate buffer
- Rinse 3 times (for 10 seconds) with 25mL of phosphate buffer
- 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.
- Provide a blood sample for hs-CRP.
- 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.
.
- Conditions
- Plaque, Inflammation
- Being tested
- Plaque identifying toothpaste, Non-plaque identifying toothpaste
- Keywords
- plaque identifying toothpaste, plaque score, C-reactive protein
- Medical subject headings
- Plaque, Amyloid, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plaque identifying toothpasteOther
Plaque identifying toothpaste with targetol
Non-plaque identifying toothpasteOther
Non-plaque identifying toothpaste without targetol
| Study group | Role | What they receive |
|---|---|---|
| Plaque identifying toothpaste | Active comparator | A 30 day supply of daily syringes containing a plaque identifying toothpaste with targetol Receives: Other: Plaque identifying toothpaste |
| Non-plaque identifying toothpaste | Active comparator | A 30 day supply of daily syringes containing an identical non plaque identifying toothpaste without targetol Receives: Other: Non-plaque identifying toothpaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Oral Plaque
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.
Measured: Baseline to 30 - 60 days post baseline
Change in Hs-CRP Serum Level
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.
Measured: Baseline to 30 - 60 days post baseline
Secondary outcomes (2)
Change in Oral Plaque - PSS Analysis
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).
Measured: Baseline to 30-60 days post
Change in Inflammation - PSS Analysis
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
Measured: Baseline to 30-60 days post
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2016 (estimated)
- Study start1 Sep 2015
- Primary completion1 Apr 2016
- Study completion22 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (35)Papers the sponsor has linked to this study.
- Other trials for PlaqueStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Florida Atlantic University
- Responsible party
- Principal investigator, Kim Fasula, University of Illinois Chicago
- Investigators
- Kimberly Fasula, MS, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02666508
- Sponsor's protocol ID
- 2015-0620
- Status last verified
- Jan 2021
- First submitted
- 24 Jan 2016
- Last updated
- 14 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 25463904de 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.
PubMed 20508025Kholy 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.
PubMed 25892452Mbawalla HS, Masalu JR, Astrom 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.
PubMed 21118499Gundala 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.
PubMed 22114373Al-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.
PubMed 22044115Carter K, Landini G, Walmsley AD. Automated quantification of dental plaque accumulation using digital imaging. J Dent. 2004 Nov;32(8):623-8. doi: 10.1016/j.jdent.2004.06.006.
PubMed 15476956Short 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. doi: 10.1155/2014/861461.
PubMed 25844257Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, de Ferranti S, Despres 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. No abstract available.
PubMed 25520374Anderson KM, Odell PM, Wilson PW, Kannel WB. Cardiovascular disease risk profiles. Am Heart J. 1991 Jan;121(1 Pt 2):293-8. doi: 10.1016/0002-8703(91)90861-b.
PubMed 1985385Loos 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. doi: 10.1902/jop.2000.71.10.1528.
PubMed 11063384Danesh 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. doi: 10.1056/NEJMoa032804.
PubMed 15070788Ramamoorthy 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.
PubMed 23066303D'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. doi: 10.1177/154405910408300214.
PubMed 14742655Noack 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. doi: 10.1902/jop.2000.72.9.1221.
PubMed 11577954
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Plaque Identifying Toothpaste on Reduction of Plaque and Inflammation
- ClinicalTrials.gov ID
- NCT02666508
- Acronym / sponsor ID
- 2015-0620
- Conditions
- Plaque, Inflammation
- Keywords
- plaque identifying toothpaste, plaque score, C-reactive protein
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- Florida Atlantic University
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- 1 Apr 2016 (actual)
- Study completion
- 22 Aug 2016 (actual)
- First posted
- 28 Jan 2016 (estimated)
- Results
- Posted 14 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- Rinse for 10 seconds with 25 mL of phosphate buffer
- Rinse for 1 minute with 5.0 mL of 1240-ppm fluorescein in phosphate buffer
- Rinse 3 times (for 10 seconds) with 25mL of phosphate buffer
- 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.
- Provide a blood sample for hs-CRP.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Plaque identifying toothpaste | Active comparator | Other: Plaque identifying toothpasteA 30 day supply of daily syringes containing a plaque identifying toothpaste with targetol |
| Non-plaque identifying toothpaste | Active comparator | Other: Non-plaque identifying toothpasteA 30 day supply of daily syringes containing an identical non plaque identifying toothpaste without targetol |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (13 listed)
- • 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
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 |
|---|---|---|
| Plaque identifying toothpastePlaque identifying toothpaste with targetol | Other | Plaque identifying toothpaste |
| Non-plaque identifying toothpasteNon-plaque identifying toothpaste without targetol | Other | Non-plaque identifying toothpaste |
Primary outcome
Change in Oral Plaque
Time frame: 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.
Change in Hs-CRP Serum Level
Time frame: 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.
2 secondary outcomes
Change in Oral Plaque - PSS Analysis
Time frame: Baseline to 30-60 days post
Change in Inflammation - PSS Analysis
Time frame: Baseline to 30-60 days post
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25463904Kim 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.
- Background: PubMed 20508025de 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.
- Background: PubMed 25892452Kholy 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.
- Background: PubMed 21118499Mbawalla HS, Masalu JR, Astrom 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.
- Background: PubMed 22114373Gundala 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.
- Background: PubMed 22044115Al-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.
- Background: PubMed 15476956Carter K, Landini G, Walmsley AD. Automated quantification of dental plaque accumulation using digital imaging. J Dent. 2004 Nov;32(8):623-8. doi: 10.1016/j.jdent.2004.06.006.
- Background: PubMed 25844257Short 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. doi: 10.1155/2014/861461.
- Background: PubMed 25520374Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, de Ferranti S, Despres 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. No abstract available.
- Background: PubMed 1985385Anderson KM, Odell PM, Wilson PW, Kannel WB. Cardiovascular disease risk profiles. Am Heart J. 1991 Jan;121(1 Pt 2):293-8. doi: 10.1016/0002-8703(91)90861-b.
- Background: PubMed 11063384Loos 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. doi: 10.1902/jop.2000.71.10.1528.
- Background: PubMed 15070788Danesh 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. doi: 10.1056/NEJMoa032804.
- The World Health Organization. Cardiovascular Diseases (CVDs)Link provided by the sponsor.
- American Heart Association. Heart and Stroke Statistics.Link provided by the sponsor.
- Relationship between serum antibody titres to porphyromonas gingivalis and hs-CRP levels as inflammatory markers of periodontitis.Link provided by the sponsor.
- Hs-CRP: The test \| high-sensitivity C-reactive protein; hs-CRP test: High-sensitivity C-reactive protein \| lab tests online.Link provided by the sponsor.
- HSRIC: Grants, funding and fellowships.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Enrolling by invitation
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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. This study is not recruiting at the moment.
Kimberly Fasula, MS principal investigator
University of Illinois Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plaque identifying toothpaste and Non-plaque identifying toothpaste in people with Plaque and Inflammation, run by University of Illinois Chicago 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 5 inclusion and 13 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: finished, as of the sponsor's last update on 14 Jan 2021. 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?
Yes. Results are posted in the registry (first posted 14 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Oral Plaque (time frame: Baseline to 30 - 60 days post baseline). The study lists 2 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 NCT02666508, which also lists 35 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 14 Jan 2021.