PlaqueNCT03214406
Clinical Evaluation of the Efficacy of a Marketed Dentifrice on Plaque and Gingivitis
A study testing Arm & Hammer Advance White Brilliant Sparkle (Test product) in people with Plaque and Gingivitis, run by Church & Dwight Company, Inc. at 1 site in Canada.
Trial summary
Parallel, double blind, randomized, Institutional Review Board (IRB) -approved study involving approximately 160 subjects to complete. Subjects were randomly assigned to either the test product (Arm \& Hammer Advance White Brilliant Sparkle) or the control (Crest Cavity Protection Regular) based on baseline mean… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Plaque, Gingivitis
- What is being tested?
- Arm & Hammer Advance White Brilliant Sparkle (Test product)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 181 participants
- Where
- 1 siteCanada
- Study dates
- 8 Feb 2010to 3 Aug 2010
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Have provided written informed consent prior to being entered into study
- Have at least 18 scorable natural teeth as determined by the examiner
- Have a mean baseline plaque index score greater than or equal to 2.0 as determined by the Soparkar Modification of the Turesky modification of the Quigley-Hein Plaque Index
- Have a mean baseline gingival index score of greater than 1.80 as determined by the Modified Gingival Index
- Presence of greater than 10 bleeding sites upon probing
- Agree not to have dental prophylaxis or any other elective, no -emergency dental procedures (other than those provided during the study) any time during the study
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- Agree to abstain from use of floss, chewing gum, mouth rinses, any toothpaste other than the study toothpaste, tooth whitening products (either professional or at home use) and all other oral hygiene other than the study procedures for the duration of the study.
- Agree to refrain from all oral hygiene on the morning of each evaluation visit and to refrain from eating and drinking for 4 hours prior to each evaluation visit
- Agree to comply with the conditions and schedule of the study
Who cannot join
- Physical limitations or restrictions that might preclude normal tooth brushing
- Evidence of gross oral pathology, including widespread caries or chronic neglect, extensive restoration, pre-existing gross plaque or soft or hard tissue tumor of the oral cavity.
- Heavy calculus that might interfere with evaluations as determined by the Investigator/Examiner
- Chronic disease with concomitant oral manifestations
- Conditions requiring antibiotic prophylaxis prior to invasive procedures, such as heart murmur, history of rheumatic fever, valvular disease or certain prosthetic implants
- History of uncontrolled diabetes or hepatic or renal disease, or other serious conditions or transmittable diseases (eg cardiovascular disease, AIDS)
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- Subjects with fixed or removable orthodontic appliances or removable partial dentures
- Subjects who are currently undergoing, or require, extensive dental work or orthodontic treatment
- Treatment with antibiotics within the 1-month period before the baseline examination, or a condition that is likely to require antibiotic treatment over the course of the trial
- Chronic treatment (2 weeks or more) with any medication known to affect periodontal status (including phenytoin, calcium antagonists, cyclosporine, coumarin, nonsteroidal anti-inflammatory drugs, and aspirin) within 1 month of baseline examination. All other medications for chronic medical conditions must have been initiated at least 3 months before enrollment
- Moderately advanced to advanced periodontitis as indicated by clinical attachment loss, radiographic alveolar bone loss, and/or periodontal pockets greater than 5 millimeters
- Having history of early-onset periodontitis or acute necrotizing ulcerative gingivitis
- Concomitant endodontic or periodontal therapy other than prophylaxis in the last 6 months
- Professional prophylaxis within 1 month prior to the baseline clinical evaluation
- Currently using bleaching trays
- Currently using power toothbrush
- Currently a smoker or recently (during the past 6 months) quit smoking
- Having any oral piercings in or around the oral cavity with ornament or accessory
- Regular use of any chemotherapeutic antiplaque/antigingivitis products such as Colgate Total, Crest Pro-Health, Listerine, etc
- History of significant adverse effects following use of oral hygiene products such as toothpastes and mouthrinses
- Subjects who are nursing, pregnant or plan to become pregnant for the duration of the study
Trial locations and contacts
1 site in 1 country.
About this study
Parallel, double blind, randomized, Institutional Review Board (IRB) -approved study involving approximately 160 subjects to complete. Subjects were randomly assigned to either the test product (Arm \& Hammer Advance White Brilliant Sparkle) or the control (Crest Cavity Protection Regular) based on baseline mean whole-mouth plaque and gingival scores and age.Subjects brushed with their assigned dentifrice two times (2X) daily and were evaluated for gingivitis, bleeding and plaque at Baseline and after 4-, 8-, and 12-weeks of product use. Return to pre-study hygiene regimen for 4 weeks and final evaluation at 16 weeks.
- Conditions
- Plaque, Gingivitis
- Being tested
- Arm & Hammer Advance White Brilliant Sparkle (Test product), Crest Cavity Protection Regular Toothpaste (Negative Control)
- Medical subject headings
- Plaque, Amyloid, Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm & Hammer Advance White Brilliant Sparkle (Test product)Drug
20% sodium bicarbonate
Crest Cavity Protection Regular Toothpaste (Negative Control)Drug
Negative control
| Study group | Role | What they receive |
|---|---|---|
| Arm & Hammer Advance White Brilliant Sparkle (Test product) | Experimental | 2X daily brushing for 12 weeks with Arm \& Hammer Advance White Brilliant Sparkle (Test product). Return to pre-study hygiene regimen for 4 weeks and final evaluation at 16 weeks. Receives: Drug: Arm & Hammer Advance White Brilliant Sparkle (Test product) |
| Crest Cavity Protection Regular Toothpaste (Negative Control) | Active comparator | 2X daily brushing for 12 weeks with Crest Cavity Protection Regular Toothpaste (Negative Control). Return to pre-study hygiene regimen for 4 weeks and final evaluation at 16 weeks. Receives: Drug: Crest Cavity Protection Regular Toothpaste (Negative Control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Within-Treatment Whole-Mouth Differences (vs Baseline) - Gingival Efficacy
change in score as measured by Gingival Index (0=absence of inflammation, 1=mild inflammation: slight change in color, little change in texture of any portion of but not the entire marginal or papillary gingival unit, 2=mild inflammation: slight change in color, little change in texture to entire marginal or papillary gingival unit, 3=moderate inflammation: glazing, redness, edema and/or hypertrophy of the marginal or papillary gingival unit, 4=severe inflammation: marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration. The scale ranges from 0-4.
Measured: 16 weeks
Within-Treatment Whole-Mouth Differences (vs Baseline) Gingival Bleeding Efficacy
change in score as measured by Gingival Bleeding Index (0=absence of bleeding after 30 seconds, 1= bleeding observed after 30 seconds, 2= bleeding occurs instantly). The scale ranges from 0-2.
Measured: 16 weeks
Within-Treatment Whole-Mouth Differences (vs Baseline) - Plaque Efficacy
change in score as measured by Plaque Index (0=no visible plaque, 1=separate flecks of plaque at the cervical margin of the tooth, 2=a thin, continuous band of plaque (up to 1mm wide) at the cervical margin, 3= a band of plaque wider than 1 mm but covering less than one-third of the crown, 4=plaque covering at least one-third but less than two-thirds of the crown, 5= plaque covering two-thirds or more of the crown. The scale ranges from 0-5.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study start8 Feb 2010
- Primary completion3 Aug 2010
- Study completion3 Aug 2010
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.
- Other trials for PlaqueStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- Church & Dwight Company, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03214406
- Sponsor's protocol ID
- ST-7323
- Status last verified
- Apr 2021
- First submitted
- 10 Jul 2017
- Last updated
- 11 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Efficacy of a Marketed Dentifrice on Plaque and Gingivitis
- ClinicalTrials.gov ID
- NCT03214406
- Acronym / sponsor ID
- ST-7323
- Conditions
- Plaque, Gingivitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- Church & Dwight Company, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Feb 2010 (actual)
- Primary completion
- 3 Aug 2010 (actual)
- Study completion
- 3 Aug 2010 (actual)
- First posted
- 11 Jul 2017 (actual)
- Results
- Posted 23 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Parallel, double blind, randomized, Institutional Review Board (IRB) -approved study involving approximately 160 subjects to complete. Subjects were randomly assigned to either the test product (Arm \& Hammer Advance White Brilliant Sparkle) or the control (Crest Cavity Protection Regular) based on baseline mean whole-mouth plaque and gingival scores and age.Subjects brushed with their assigned dentifrice two times (2X) daily and were evaluated for gingivitis, bleeding and plaque at Baseline and after 4-, 8-, and 12-weeks of product use. Return to pre-study hygiene regimen for 4 weeks and final evaluation at 16 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm & Hammer Advance White Brilliant Sparkle (Test product) | Experimental | Drug: Arm & Hammer Advance White Brilliant Sparkle (Test product)2X daily brushing for 12 weeks with Arm \& Hammer Advance White Brilliant Sparkle (Test product). Return to pre-study hygiene regimen for 4 weeks and final evaluation at 16 weeks. |
| Crest Cavity Protection Regular Toothpaste (Negative Control) | Active comparator | Drug: Crest Cavity Protection Regular Toothpaste (Negative Control)2X daily brushing for 12 weeks with Crest Cavity Protection Regular Toothpaste (Negative Control). Return to pre-study hygiene regimen for 4 weeks and final evaluation at 16 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Have provided written informed consent prior to being entered into study
- Have at least 18 scorable natural teeth as determined by the examiner
- Have a mean baseline plaque index score greater than or equal to 2.0 as determined by the Soparkar Modification of the Turesky modification of the Quigley-Hein Plaque Index
- Have a mean baseline gingival index score of greater than 1.80 as determined by the Modified Gingival Index
- Presence of greater than 10 bleeding sites upon probing
Key exclusion criteria (21 listed)
- Physical limitations or restrictions that might preclude normal tooth brushing
- Evidence of gross oral pathology, including widespread caries or chronic neglect, extensive restoration, pre-existing gross plaque or soft or hard tissue tumor of the oral cavity.
- Heavy calculus that might interfere with evaluations as determined by the Investigator/Examiner
- Chronic disease with concomitant oral manifestations
- Conditions requiring antibiotic prophylaxis prior to invasive procedures, such as heart murmur, history of rheumatic fever, valvular disease or certain prosthetic implants
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 |
|---|---|---|
| Arm & Hammer Advance White Brilliant Sparkle (Test product)20% sodium bicarbonate | Drug | Arm & Hammer Advance White Brilliant Sparkle (Test product) |
| Crest Cavity Protection Regular Toothpaste (Negative Control)Negative control | Drug | Crest Cavity Protection Regular Toothpaste (Negative Control) |
Primary outcome
Within-Treatment Whole-Mouth Differences (vs Baseline) - Gingival Efficacy
Time frame: 16 weeks
change in score as measured by Gingival Index (0=absence of inflammation, 1=mild inflammation: slight change in color, little change in texture of any portion of but not the entire marginal or papillary gingival unit, 2=mild inflammation: slight change in color, little change in texture to entire marginal or papillary gingival unit, 3=moderate inflammation: glazing, redness, edema and/or hypertrophy of the marginal or papillary gingival unit, 4=severe inflammation: marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration. The scale ranges from 0-4.
Within-Treatment Whole-Mouth Differences (vs Baseline) Gingival Bleeding Efficacy
Time frame: 16 weeks
change in score as measured by Gingival Bleeding Index (0=absence of bleeding after 30 seconds, 1= bleeding observed after 30 seconds, 2= bleeding occurs instantly). The scale ranges from 0-2.
Within-Treatment Whole-Mouth Differences (vs Baseline) - Plaque Efficacy
Time frame: 16 weeks
change in score as measured by Plaque Index (0=no visible plaque, 1=separate flecks of plaque at the cervical margin of the tooth, 2=a thin, continuous band of plaque (up to 1mm wide) at the cervical margin, 3= a band of plaque wider than 1 mm but covering less than one-third of the crown, 4=plaque covering at least one-third but less than two-thirds of the crown, 5= plaque covering two-thirds or more of the crown. The scale ranges from 0-5.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arm & Hammer Advance White Brilliant Sparkle (Test product) in people with Plaque and Gingivitis, run by Church & Dwight Company, Inc. at 1 site in Canada.
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 9 inclusion and 21 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 11 May 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 Canada. 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 23 Jul 2019). 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?
Within-Treatment Whole-Mouth Differences (vs Baseline) - Gingival Efficacy (time frame: 16 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 May 2021.