InflammationCOHESIONNCT03641989
Correlation Between Oral Health and Systemic Inflammation (COHESION)
A study testing Plaque disclosing toothpaste and Non-plaque disclosing toothpaste in people with Inflammation and Periodontal Disease, run by Marshfield Clinic Research Foundation at 1 site in United States.
Trial summary
COHESION is a randomized trial targeting reduction of systemic inflammation through an oral hygiene regimen incorporating a plaque-disclosing toothpaste and a control toothpaste. Read more about this study
- Who is it for?
- Ages 21 to 84 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammation, Periodontal Disease, Gingivitis
- What is being tested?
- Plaque disclosing toothpaste and Non-plaque disclosing toothpaste
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Sep 2018to 30 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 to 84 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Willing and able to provide written informed consent
- Speak and understand English
- Willing and able to comply with all procedures for the duration of the trial
- ≥ 12 natural teeth
- Baseline hs-CRP level ≥0.5 and ≤10.0 mg/L
- No exposure to statins
- Presence of dental provider assessed gingivitis or mild, moderate or severe periodontitis based on the American Academy of Periodontology (AAP) and presence of visible plaque/calculus
Who cannot join
- Diagnosis or history of atherosclerosis, myocardial infarction, stroke, transient ischemic attack, peripheral vascular disease
- History of inflammatory conditions such as rheumatoid arthritis, lupus or other chronic inflammatory condition; cancer
- Exposure to statins
- Consistent or prescribed use of aspirin, nonsteroidal anti-inflammatory drugs (NSAIDS) or immunosuppressive drugs (defined as 10 or more doses in past 30 days)
- Removable appliances only if gum inflammation is present where the appliance is seated
- Dental prophylaxis [e.g., cleaning, scaling or root planning to mechanically remove plaque and calculus] within 30 days of randomization
Show all 13Show fewer
- Infection anywhere in the body 2 weeks prior to baseline visit (excluding presence of PD) or exposure to antibiotics or anti-viral agents during this time frame
- Trauma to oral cavity within two weeks of baseline visit
- Current tobacco use
- Women who are pregnant or breast-feeding
- Use of any investigational products within 30 days of randomization
- History of allergies to dyes
- Deemed not suitable for study participation based on the clinical judgment of the investigator
Trial locations and contacts
1 site in 1 country.
United States1 site
Marshfield Clinic-Marshfield Center
Marshfield, Wisconsin, 54449
About this study
COHESION is a randomized trial targeting reduction of systemic inflammation through an oral hygiene regimen incorporating a plaque-disclosing toothpaste and a control toothpaste.
Read the detailed description
The present pilot trial will test the hypothesis that regular brushing with Plaque HD (interventional toothpaste) compared to conventional toothpaste (control) for 30 days in participants with confirmed mild to severe PD will significantly reduce hsCRP levels, a sensitive marker of inflammation and predictor of CVD. By completing the COHESION trial, we will collect important and relevant data to support application for investigator-initiated research funding from the US National Institutes of Health to directly test whether Plaque HD reduces CVD in larger, scaled multi-center randomized trial.
Participants will be asked to participate in three visits. During Visit One, we will be reviewing their medical and dental information as well as performing an oral evaluation to determine their level of gingivitis or periodontal disease. If the participant remains eligible, their blood will be drawn to determine whether the baseline hsCRP level falls within the eligible range (≥0.5 to ≤10.0 mg/L).
During Visit Two, if the participant remains eligible, they will be randomized and given a 30-day supply of the interventional or control toothpaste along with a study diary to track their progress.
The participant will receive a follow-up call 15 days after Visit Two to track compliance with study activity and monitor for any adverse events.
30-days later, during Visit Three, the participants will undergo another oral evaluation in addition to a second blood draw to measure the hsCRP level after using their assigned toothpaste for 30 days.
- Conditions
- Inflammation, Periodontal Disease, Gingivitis
- Being tested
- Plaque disclosing toothpaste, Non-plaque disclosing toothpaste
- Keywords
- Toothpaste, Inflammation, Periodontal Disease, hsCRP, Oral health, Oral hygiene
- Medical subject headings
- Inflammation, Periodontal Diseases, Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plaque disclosing toothpasteOther
Plaque identifying toothpaste with a FDA-registered seed-extract dye (Annatto (Bixa Orellana)) and FD\&C Blue No. 1.
Non-plaque disclosing toothpasteOther
Toothpaste that does not contain the FDA-registered seed-extract dye (Annatto (Bixa Orellana)) and FD\&C Blue No. 1.
| Study group | Role | What they receive |
|---|---|---|
| Plaque disclosing toothpaste | Active comparator | Based on a randomization schema, a 30 day supply of the plaque disclosing toothpaste will be distributed to the participant. Participants will be instructed to brush two times a day for 30 days with the plaque disclosing toothpaste; avoiding the use of mouth rinses and floss. They will also be instructed to avoid any dental prophylaxis (e.g., cleaning, scaling or root planing to mechanically remove plaque and calculus) while on the trial and 30 days before they are enrolled. Receives: Other: Plaque disclosing toothpaste |
| Non-plaque disclosing toothpaste | Placebo comparator | Based on a randomization schema, a 30 day supply of the over-the-counter, non-plaque disclosing toothpaste will be distributed to the participant. Participants will be instructed to brush two times a day for 30 days with the plaque disclosing toothpaste; avoiding the use of mouth rinses and floss. They will also be instructed to avoid any dental prophylaxis (e.g., cleaning, scaling or root planing to mechanically remove plaque and calculus) while on the trial and 30 days before they are enrolled. Receives: Other: Non-plaque disclosing toothpaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hsCRP levels with the use of the assigned toothpaste.
The primary outcome measure is magnitude of change in level of high sensitivity CRP (hsCRP) pre-trial compared to post trial as a surrogate marker to monitor change in local and systemic inflammation. Study eligible subjects with hsCRP levels between 0.5 and 10.0 mg/L at baseline (Visit 1) will be randomized to brushing for 30 days with one of two toothpastes followed by reassessment at visit 3 at the end of the intervention. Since distribution of hsCRP is skewed toward higher values, to satisfy statistical model assumptions, significance of the observed differences in outcomes between groups from baseline to day 30 will be tested on log-transformed data by using ANCOVA with treatment and baseline measurement as main factors and treatment by baseline measurement interaction. All significance tests for hsCRP will be conducted using R version 3.3.1 and two-sided significance levels of 0.05.
Measured: 30 days
Secondary outcomes (5)
Bleeding on Probing (BOP
Decrease in number of teeth with BOP following tooth-brushing intervention from baseline visit is a represents a primary clinical indicator of reduction in local inflammation of periodontal tissue. BOP per tooth will be evaluated by a dental professional using a periodontal probe along the gum line of each tooth at 6 sites per tooth at the baseline pre-trial visit (Visit One) and at post trial Visit Three after the 30 day tooth brushing intervention. The outcome measure will be the difference in the number of teeth exhibiting BOP pre and post the 30 day trial. This variable has no units and is a dichotomous nominal variable (i.e yes/no) evaluated on a per-tooth basis across total number of evaluable teeth present in the participant's mouth. (Scoring: 1=BOP present; 0=BOP absent).
Measured: 30 days
Periodontal Pocket Depth (PPD)
PPD per tooth at 6 sites per tooth as a measure of periodontal health at baseline pre and post use of the assigned toothpaste will be assessed to determine presence and extent of PD. A dental professional will perform a periodontal assessment, pre (Visit one) and post (Visit three) the 30 day tooth brushing intervention applying Periodontology (AAP) 1999 Classification Criteria with 2015 updates to classify extent of PD as a continuous variable. PPD measurement, measured in mm, will be carried out pre and post clinical trial participation using a periodontal probe.
Measured: 30 days
Plaque Levels
Each evaluable tooth will be examined by a dental professional for presence of supra-gingival biofilm deposited by oral pathogens using a periodontal probe at the pre baseline visit (Visit One) and post (Visit Three) visit following the 30 day tooth brushing intervention. Number of teeth with a change in visible plaque deposits post-trial compared to pre-trial levels will be determined. This variable has no units and will be evaluated as a dichotomous nominal variable (i.e., yes/no) on a per-tooth basis across total number of evaluable teeth. (Scoring: 1=visible plaque present; 0= no visible plaque).
Measured: 30 days
Overall oral health assessment and analytical plan
Analytical plan for secondary outcomes: Significance of any differences in oral health characteristics at baseline (pre) and post intervention will be tested by t-tests for continuous and chi-square tests for discrete variables. For parameter estimation, means and mean ratios will calculated for each treatment group at each time point along with standard deviations. The purpose of collection of overall oral health assessment is to inform on the relative health of the participants mouth at time zero to support conduct of a sub-analysis to determine whether the magnitude of change in hsCRP correlated with relative health of the mouth determined during the pre-trial oral health assessment.
Measured: 30 days
Evaluate CD4/CD8 ratio for participants over the age of 45
CD4/CD8 ratios will be measured in the subset of subjects who meet eligibility based on hsCRP measures but whose CD4/CD8 ratio is less than 1.2 following analysis of blood collected in visit 1. Subjects whose CD4/CD8 ratio fell below 1.2 in visit 1 will have reassessment of CD4/CD8 ratio done on blood collected in visit 3. The magnitude of change in CD4/CD8 pre and post-trial will be evaluated tested by t-test analysis for this continuous variable.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2018
- Study start17 Sep 2018
- Primary completion30 Dec 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for InflammationStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to brush twice daily for 30 days with the plaque disclosing agent toothpaste or a reference, non-plaque disclosing toothpaste. Toothpastes are comparable based on equivalent content of the active ingredient: fluoride.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marshfield Clinic Research Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- University of Wisconsin, Madison
- Responsible party
- Principal investigator, Amit Acharya, BDS, MS, PhD, Marshfield Clinic Research Foundation
- Investigators
- Amit Acharya, BDS, MS, PhD, Principal investigator, Marshfield Clinic Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03641989
- Sponsor's protocol ID
- ACH10317
- Acronym
- COHESION
- Status last verified
- Feb 2020
- First submitted
- 26 Jun 2018
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Eke PI, Dye BA, Wei L, Slade GD, Thornton-Evans GO, Borgnakke WS, Taylor GW, Page RC, Beck JD, Genco RJ. Update on Prevalence of Periodontitis in Adults in the United States: NHANES 2009 to 2012. J Periodontol. 2015 May;86(5):611-22. doi: 10.1902/jop.2015.140520. Epub 2015 Feb 17.
PubMed 25688694Glurich I, Acharya A, Shukla SK, Nycz GR, Brilliant MH. The oral-systemic personalized medicine model at Marshfield Clinic. Oral Dis. 2013 Jan;19(1):1-17. doi: 10.1111/j.1601-0825.2012.01921.x. Epub 2012 Mar 28.
PubMed 22458294Ridker 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. doi: 10.1056/NEJM199704033361401.
PubMed 9077376Demmer RT, Trinquart L, Zuk A, Fu BC, Blomkvist J, Michalowicz BS, Ravaud P, Desvarieux M. The influence of anti-infective periodontal treatment on C-reactive protein: a systematic review and meta-analysis of randomized controlled trials. PLoS One. 2013 Oct 14;8(10):e77441. doi: 10.1371/journal.pone.0077441. eCollection 2013.
PubMed 24155956Anitha V, Nair S, Shivakumar V, Shanmugam M, Priya BM, Rajesh P. Estimation of high sensitivity C-reactive protein in patients with periodontal disease and without coronary artery disease. Indian J Dent Res. 2015 Sep-Oct;26(5):500-3. doi: 10.4103/0970-9290.172048.
PubMed 26672420Ajwani S, Mattila KJ, Narhi TO, Tilvis RS, Ainamo A. Oral health status, C-reactive protein and mortality--a 10 year follow-up study. Gerodontology. 2003 Jul;20(1):32-40. doi: 10.1111/j.1741-2358.2003.00032.x.
PubMed 12926749VanWormer JJ, Acharya A, Greenlee RT, Nieto FJ. Oral hygiene and cardiometabolic disease risk in the survey of the health of Wisconsin. Community Dent Oral Epidemiol. 2013 Aug;41(4):374-84. doi: 10.1111/cdoe.12015. Epub 2012 Oct 29.
PubMed 23106415Fasula K, Evans CA, Boyd L, Giblin L, Belavsky BZ, Hetzel S, McBride P, DeMets DL, Hennekens CH. Randomized Trial of Plaque-Identifying Toothpaste: Decreasing Plaque and Inflammation. Am J Med. 2017 Jun;130(6):746-749. doi: 10.1016/j.amjmed.2016.09.003. Epub 2016 Oct 19.
PubMed 27771276Henson BS, Wong DT. Collection, storage, and processing of saliva samples for downstream molecular applications. Methods Mol Biol. 2010;666:21-30. doi: 10.1007/978-1-60761-820-1_2.
PubMed 20717775Lim Y, Totsika M, Morrison M, Punyadeera C. The saliva microbiome profiles are minimally affected by collection method or DNA extraction protocols. Sci Rep. 2017 Aug 17;7(1):8523. doi: 10.1038/s41598-017-07885-3.
PubMed 28819242
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Oral Health and Systemic Inflammation (COHESION)
- ClinicalTrials.gov ID
- NCT03641989
- Acronym / sponsor ID
- COHESION / ACH10317
- Conditions
- Inflammation, Periodontal Disease, Gingivitis
- Keywords
- Toothpaste, Inflammation, Periodontal Disease, hsCRP, Oral health, Oral hygiene
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Marshfield Clinic Research FoundationUniversity, hospital or other
- Collaborators
- University of Wisconsin, Madison
- Study start
- 17 Sep 2018 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 22 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
COHESION is a randomized trial targeting reduction of systemic inflammation through an oral hygiene regimen incorporating a plaque-disclosing toothpaste and a control toothpaste.
Detailed description
The present pilot trial will test the hypothesis that regular brushing with Plaque HD (interventional toothpaste) compared to conventional toothpaste (control) for 30 days in participants with confirmed mild to severe PD will significantly reduce hsCRP levels, a sensitive marker of inflammation and predictor of CVD. By completing the COHESION trial, we will collect important and relevant data to support application for investigator-initiated research funding from the US National Institutes of Health to directly test whether Plaque HD reduces CVD in larger, scaled multi-center randomized trial.
Participants will be asked to participate in three visits. During Visit One, we will be reviewing their medical and dental information as well as performing an oral evaluation to determine their level of gingivitis or periodontal disease. If the participant remains eligible, their blood will be drawn to determine whether the baseline hsCRP level falls within the eligible range (≥0.5 to ≤10.0 mg/L).
During Visit Two, if the participant remains eligible, they will be randomized and given a 30-day supply of the interventional or control toothpaste along with a study diary to track their progress.
The participant will receive a follow-up call 15 days after Visit Two to track compliance with study activity and monitor for any adverse events.
30-days later, during Visit Three, the participants will undergo another oral evaluation in addition to a second blood draw to measure the hsCRP level after using their assigned toothpaste for 30 days.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be randomized to brush twice daily for 30 days with the plaque disclosing agent toothpaste or a reference, non-plaque disclosing toothpaste. Toothpastes are comparable based on equivalent content of the active ingredient: fluoride.
| Arm | Type | Receives |
|---|---|---|
| Plaque disclosing toothpaste | Active comparator | Other: Plaque disclosing toothpasteBased on a randomization schema, a 30 day supply of the plaque disclosing toothpaste will be distributed to the participant. Participants will be instructed to brush two times a day for 30 days with the plaque disclosing toothpaste; avoiding the use of mouth rinses and floss. They will also be instructed to avoid any dental prophylaxis (e.g., cleaning, scaling or root planing to mechanically remove plaque and calculus) while on the trial and 30 days before they are enrolled. |
| Non-plaque disclosing toothpaste | Placebo comparator | Other: Non-plaque disclosing toothpasteBased on a randomization schema, a 30 day supply of the over-the-counter, non-plaque disclosing toothpaste will be distributed to the participant. Participants will be instructed to brush two times a day for 30 days with the plaque disclosing toothpaste; avoiding the use of mouth rinses and floss. They will also be instructed to avoid any dental prophylaxis (e.g., cleaning, scaling or root planing to mechanically remove plaque and calculus) while on the trial and 30 days before they are enrolled. |
Who may qualify
- Ages
- 21 to 84 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Willing and able to provide written informed consent
- Speak and understand English
- Willing and able to comply with all procedures for the duration of the trial
- ≥ 12 natural teeth
- Baseline hs-CRP level ≥0.5 and ≤10.0 mg/L
Key exclusion criteria (13 listed)
- Diagnosis or history of atherosclerosis, myocardial infarction, stroke, transient ischemic attack, peripheral vascular disease
- History of inflammatory conditions such as rheumatoid arthritis, lupus or other chronic inflammatory condition; cancer
- Exposure to statins
- Consistent or prescribed use of aspirin, nonsteroidal anti-inflammatory drugs (NSAIDS) or immunosuppressive drugs (defined as 10 or more doses in past 30 days)
- Removable appliances only if gum inflammation is present where the appliance is seated
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 disclosing toothpastePlaque identifying toothpaste with a FDA-registered seed-extract dye (Annatto (Bixa Orellana)) and FD\&C Blue No. 1. | Other | Plaque disclosing toothpaste |
| Non-plaque disclosing toothpasteToothpaste that does not contain the FDA-registered seed-extract dye (Annatto (Bixa Orellana)) and FD\&C Blue No. 1. | Other | Non-plaque disclosing toothpaste |
Primary outcome
Change in hsCRP levels with the use of the assigned toothpaste.
Time frame: 30 days
The primary outcome measure is magnitude of change in level of high sensitivity CRP (hsCRP) pre-trial compared to post trial as a surrogate marker to monitor change in local and systemic inflammation. Study eligible subjects with hsCRP levels between 0.5 and 10.0 mg/L at baseline (Visit 1) will be randomized to brushing for 30 days with one of two toothpastes followed by reassessment at visit 3 at the end of the intervention. Since distribution of hsCRP is skewed toward higher values, to satisfy statistical model assumptions, significance of the observed differences in outcomes between groups from baseline to day 30 will be tested on log-transformed data by using ANCOVA with treatment and baseline measurement as main factors and treatment by baseline measurement interaction. All significance tests for hsCRP will be conducted using R version 3.3.1 and two-sided significance levels of 0.05.
5 secondary outcomes
Bleeding on Probing (BOP
Time frame: 30 days
Periodontal Pocket Depth (PPD)
Time frame: 30 days
Plaque Levels
Time frame: 30 days
Overall oral health assessment and analytical plan
Time frame: 30 days
Evaluate CD4/CD8 ratio for participants over the age of 45
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2020.
- Background: PubMed 25688694Eke PI, Dye BA, Wei L, Slade GD, Thornton-Evans GO, Borgnakke WS, Taylor GW, Page RC, Beck JD, Genco RJ. Update on Prevalence of Periodontitis in Adults in the United States: NHANES 2009 to 2012. J Periodontol. 2015 May;86(5):611-22. doi: 10.1902/jop.2015.140520. Epub 2015 Feb 17.
- Background: PubMed 22458294Glurich I, Acharya A, Shukla SK, Nycz GR, Brilliant MH. The oral-systemic personalized medicine model at Marshfield Clinic. Oral Dis. 2013 Jan;19(1):1-17. doi: 10.1111/j.1601-0825.2012.01921.x. Epub 2012 Mar 28.
- Background: PubMed 9077376Ridker 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. doi: 10.1056/NEJM199704033361401.
- Background: PubMed 24155956Demmer RT, Trinquart L, Zuk A, Fu BC, Blomkvist J, Michalowicz BS, Ravaud P, Desvarieux M. The influence of anti-infective periodontal treatment on C-reactive protein: a systematic review and meta-analysis of randomized controlled trials. PLoS One. 2013 Oct 14;8(10):e77441. doi: 10.1371/journal.pone.0077441. eCollection 2013.
- Background: PubMed 26672420Anitha V, Nair S, Shivakumar V, Shanmugam M, Priya BM, Rajesh P. Estimation of high sensitivity C-reactive protein in patients with periodontal disease and without coronary artery disease. Indian J Dent Res. 2015 Sep-Oct;26(5):500-3. doi: 10.4103/0970-9290.172048.
- Background: PubMed 12926749Ajwani S, Mattila KJ, Narhi TO, Tilvis RS, Ainamo A. Oral health status, C-reactive protein and mortality--a 10 year follow-up study. Gerodontology. 2003 Jul;20(1):32-40. doi: 10.1111/j.1741-2358.2003.00032.x.
- Background: PubMed 23106415VanWormer JJ, Acharya A, Greenlee RT, Nieto FJ. Oral hygiene and cardiometabolic disease risk in the survey of the health of Wisconsin. Community Dent Oral Epidemiol. 2013 Aug;41(4):374-84. doi: 10.1111/cdoe.12015. Epub 2012 Oct 29.
- Background: PubMed 27771276Fasula K, Evans CA, Boyd L, Giblin L, Belavsky BZ, Hetzel S, McBride P, DeMets DL, Hennekens CH. Randomized Trial of Plaque-Identifying Toothpaste: Decreasing Plaque and Inflammation. Am J Med. 2017 Jun;130(6):746-749. doi: 10.1016/j.amjmed.2016.09.003. Epub 2016 Oct 19.
- Background: PubMed 20717775Henson BS, Wong DT. Collection, storage, and processing of saliva samples for downstream molecular applications. Methods Mol Biol. 2010;666:21-30. doi: 10.1007/978-1-60761-820-1_2.
- Background: PubMed 28819242Lim Y, Totsika M, Morrison M, Punyadeera C. The saliva microbiome profiles are minimally affected by collection method or DNA extraction protocols. Sci Rep. 2017 Aug 17;7(1):8523. doi: 10.1038/s41598-017-07885-3.
- Wisconsin Department of Health Services. Deaths.Link provided by the sponsor.
- Cornell University. Cardiovascular Disease in the United States: Economic ImpactsLink provided by the sponsor.
- Department of Health and Human Services (US). Sacher D. Oral health in America: a report of the Surgeon General. Rockville (MD): HHS, Office of the Surgeon General (US); 2000Link provided by the sponsor.
- Salimetrics. Saliva Collection and Handling Advice. 3rd Edition. 2015.Link provided by the sponsor.
Related trials for Inflammation
Not yet recruitingPhase 2
A Phase 2 Study to Compare Efficacy and Safety of a Novel Topical Therapy (APT-001, Spinosad 1.8%) in Patients With Blepharitis
Blepharitis
Not yet recruitingObservational study
Arterial Stiffness During Negative Pressure Wound Therapy for Abdominal Wall Wounds
Postoperative Abdominal Wall Wound Complications, Surgical Wound Infection
RecruitingObservational study
Effects Of Periodontal Therapy In Patients With Inflammatory Bowel Disease
Periodontal Diseases, IBD
Active, not recruitingPhase 2
A Study on the Safety and Clinical Efficacy of Guominkang in the Treatment of Diabetic Kidney Disease
Diabetic Kidney Disease (DKD), Type 2 Diabetes
Active, not recruitingPhase 2
A Study to Evaluate Efficacy, Safety and Tolerability of Hydroxychloroquine in Subjects With Parkinson's Disease
Parkinson&Amp;#39;s Disease
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.
Amit Acharya, BDS, MS, PhD principal investigator
Marshfield Clinic Research Institute
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 disclosing toothpaste and Non-plaque disclosing toothpaste in people with Inflammation and Periodontal Disease, run by Marshfield Clinic Research Foundation 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 7 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 20 Feb 2020. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 hsCRP levels with the use of the assigned toothpaste. (time frame: 30 days). 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 NCT03641989, which also lists 10 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 20 Feb 2020.