Dental PlaqueNCT02401360
A Study to Assess Clinical Gingivitis and Microbiome Following the Use of Multiple Oral Hygiene Products
A study testing China Crest® Pro-health 7 Complete Toothpaste and China Crest® Cavity Protection Toothpaste in people with Dental Plaque and Dental Gingivitis, run by Procter and Gamble.
Trial summary
This study assessed the efficacy of an oral hygiene regimen relative to a standard marketed toothpaste and manual toothbrush. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Plaque, Dental Gingivitis
- What is being tested?
- China Crest® Pro-health 7 Complete Toothpaste and China Crest® Cavity Protection Toothpaste
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- No sites listed yet
- Study dates
- Apr 2013to Apr 2013
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- give written informed consent prior to their participation;
- be 18 to 65 years of age at the time of enrollment;
- agree not to participate in any other oral/dental product studies;
- agree to delay any elective dentistry (including a dental prophylaxis);
- agree to refrain from the use of any non-study oral care products (including floss and mouthrinse) during the course of the study;
- agree to return for the scheduled visits and follow study procedures;
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- be in good general health as determined by the investigator/designee based on a review of the health history/update for participation in the study;
- have more than 10 bleeding sites at visits 1-3
- Consistency of bleeding site number at baseline may be considered;
- have a minimum of 18 natural teeth with facial and lingual scorable surfaces; and
- refrain from performing any oral hygiene or consuming anything by mouth (except a small amount of water) at least 4 hours prior to their appointment.
Who cannot join
- teeth that are grossly carious, fully crowned, extensively restored and have heavy dental calculus
- antibiotic, anti-inflammatory or anti-coagulant therapy within two weeks of to the baseline exam
- medical conditions that the investigator considers significant and that may compromise the evaluation of study results
- currently participating in any other clinical trial
- participated in a clinical trial for plaque/gingivitis within the previous 30 days
- pregnant or lactating
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- orthodontic appliances or removable partial dentures
- soft or hard tissue tumor of the oral cavity
- advanced periodontal disease
- history of hepatitis, diabetes, or other communicable diseases
- history of rheumatic fever, heart murmur, mitral valve prolapse or other conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures
- history of significant adverse effects following the use of oral hygiene products such as toothpaste
- oral pathoses that could interfere with compliance and/or examinations or that need treatment.
About this study
Official title: A Controlled Study to Assess Clinical Gingivitis and Microbiome Following the Use of Multiple Oral Hygiene Products
This study assessed the efficacy of an oral hygiene regimen relative to a standard marketed toothpaste and manual toothbrush.
- Conditions
- Dental Plaque, Dental Gingivitis
- Being tested
- China Crest® Pro-health 7 Complete Toothpaste, China Crest® Cavity Protection Toothpaste
- Medical subject headings
- Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
China Crest® Pro-health 7 Complete ToothpasteDrug
Crest® pro-health manual toothbrush Crest® pro-health gum protection rinse
China Crest® Cavity Protection ToothpasteDrug
Crest® meliliangje manual toothbrush
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Oral care regimen Receives: Drug: China Crest® Pro-health 7 Complete Toothpaste |
| Control Group | Placebo comparator | Toothbrush and toothpaste Receives: Drug: China Crest® Cavity Protection Toothpaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingivitis
Gingivitis was assessed according to the Gingival Bleeding Index
Measured: Day 0
Gingivitis
Gingivitis was assessed according to the Gingival Bleeding Index
Measured: Day 3
Gingivitis
Gingivitis was assessed according to the Gingival Bleeding Index
Measured: Day 10
Gingivitis
Gingivitis was assessed according to the Gingival Bleeding Index
Measured: Day 24
Secondary outcomes (4)
Plaque Examination
The Modified Turesky Plaque Index was used to examine plaque.
Measured: Day 0
Plaque Examination
The Modified Turesky Plaque Index was used to examine plaque.
Measured: Day 3
Plaque Examination
The Modified Turesky Plaque Index was used to examine plaque.
Measured: Day 10
Plaque Examination
The Modified Turesky Plaque Index was used to examine plaque.
Measured: Day 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2015 (estimated)
- Study startApr 2013
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Procter and Gamble
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tao He, DDS, PhD, Principal investigator, Procter and Gamble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02401360
- Sponsor's protocol ID
- 2012135
- Status last verified
- Oct 2017
- First submitted
- 24 Mar 2015
- Last updated
- 6 Oct 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Controlled Study to Assess Clinical Gingivitis and Microbiome Following the Use of Multiple Oral Hygiene Products
- ClinicalTrials.gov ID
- NCT02401360
- Acronym / sponsor ID
- 2012135
- Conditions
- Dental Plaque, Dental Gingivitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Procter and GambleIndustry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 27 Mar 2015 (estimated)
- 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.
This study assessed the efficacy of an oral hygiene regimen relative to a standard marketed toothpaste and manual toothbrush.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Drug: China Crest® Pro-health 7 Complete ToothpasteOral care regimen |
| Control Group | Placebo comparator | Drug: China Crest® Cavity Protection ToothpasteToothbrush and toothpaste |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- give written informed consent prior to their participation;
- be 18 to 65 years of age at the time of enrollment;
- agree not to participate in any other oral/dental product studies;
- agree to delay any elective dentistry (including a dental prophylaxis);
- agree to refrain from the use of any non-study oral care products (including floss and mouthrinse) during the course of the study;
Key exclusion criteria (13 listed)
- teeth that are grossly carious, fully crowned, extensively restored and have heavy dental calculus
- antibiotic, anti-inflammatory or anti-coagulant therapy within two weeks of to the baseline exam
- medical conditions that the investigator considers significant and that may compromise the evaluation of study results
- currently participating in any other clinical trial
- participated in a clinical trial for plaque/gingivitis within the previous 30 days
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 |
|---|---|---|
| China Crest® Pro-health 7 Complete ToothpasteCrest® pro-health manual toothbrush Crest® pro-health gum protection rinse | Drug | Experimental Group |
| China Crest® Cavity Protection ToothpasteCrest® meliliangje manual toothbrush | Drug | Control Group |
Primary outcome
Gingivitis
Time frame: Day 0
Gingivitis was assessed according to the Gingival Bleeding Index
Gingivitis
Time frame: Day 3
Gingivitis was assessed according to the Gingival Bleeding Index
Gingivitis
Time frame: Day 10
Gingivitis was assessed according to the Gingival Bleeding Index
Gingivitis
Time frame: Day 24
Gingivitis was assessed according to the Gingival Bleeding Index
4 secondary outcomes
Plaque Examination
Time frame: Day 0
Plaque Examination
Time frame: Day 3
Plaque Examination
Time frame: Day 10
Plaque Examination
Time frame: Day 24
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 6 Oct 2017.
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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.
Tao He, DDS, PhD principal investigator
Procter and Gamble
Questions about this trial
What is this clinical trial studying?
A study testing China Crest® Pro-health 7 Complete Toothpaste and China Crest® Cavity Protection Toothpaste in people with Dental Plaque and Dental Gingivitis, run by Procter and Gamble.
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 11 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 6 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Gingivitis (time frame: Day 0). The study lists 4 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 6 Oct 2017; AzTrials last refreshed its copy on 4 Nov 2026.