Dental PlaqueNCT01462110
A Four-Week Study to Measure the Effectiveness of an Experimental Mouthwash Used After Teeth Cleaning
A study testing 19416-154-1 and W002194-0221P in people with Dental Plaque, run by Johnson & Johnson Consumer and Personal Products Worldwide at 1 site in United States.
Trial summary
This study will test the idea that using an experimental mouth rinse after each time you brush your teeth will result in a healthier mouth than using the regular mouth rinse. Participants will be expected to avoid oral hygiene (like brushing teeth or using mouthwash) for at least 12 hours before each visit and will… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dental Plaque
- What is being tested?
- 19416-154-1 and W002194-0221P
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 87 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2011to 2 Dec 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females at least 18 years of age and in good general health.
- Must display adequate oral hygiene (i.e., brush teeth daily and exhibit no signs of oral neglect).
- Volunteers must read, sign, and receive a copy of the Informed Consent Form after the nature of the study has been fully explained.
- Must be willing to use the products according to instructions and be available for appointments.
- Baseline dental measurements meet protocol-specified criteria.
- Willingness to refrain from using all oral hygiene procedures within 12-18 hours prior to each visit.
- Refrain from eating, drinking or smoking for four hours prior to each visit.
Who cannot join
- Lip, tongue, or other form of oral piercing.
- Fixed or removable orthodontic appliance (such as bridges, braces or dentures).
- Pregnancy or breast-feeding at any time during the trial.
- Any medical, dental or psychiatric condition, abnormality or history, or use of any product or drug, that (per protocol or in the opinion of the investigator) may increase the risk to the subject associated with trial participation or investigational product administration, or interfere with the interpretation of trial results.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determination of Anti-Plaque and Anti-Gingivitis Efficacy of One Experimental Mouthrinse Following a Baseline Oral Prophylaxis: A Four Week Study
This study will test the idea that using an experimental mouth rinse after each time you brush your teeth will result in a healthier mouth than using the regular mouth rinse. Participants will be expected to avoid oral hygiene (like brushing teeth or using mouthwash) for at least 12 hours before each visit and will not be allowed to eat, drink or smoke for at least 4 hours before each visit.
At the first visit, the study will be explained to you in detail and you will be allowed to ask any questions you may have before signing a consent form. You will complete a medical/dental history and the dentist will examine your mouth, during which he will poke your gums and scrape some plaque off your teeth for testing. If you do not meet the requirements to continue in the trial, you will be told that you do not need to return for more testing.
Read more
If you meet requirements to continue, you will have an equal chance of being assigned to use either of the two mouth rinses being studied. You will be given a diary, toothbrush, toothpaste, and your assigned mouth rinse, with instructions on how they must be used.
You will be instructed not to use any unassigned oral care products and to follow your usual eating habits. You will be given appointments to return two times within the next four weeks. At those visits, the staff will check to make sure you're following the instructions and ask how you're feeling, and the dentist will do the same thing he did during the first visit.
Read the detailed description
The primary objective of this randomized, double-blind, single-center, controlled, parallel-designed clinical study is to determine the efficacy of an experimental mouth rinse on whole-mouth mean plaque and gingivitis scores as an adjunct to brushing after four weeks of use.
The secondary objectives will be to determine the efficacy of the an experimental mouth rinse as an adjunct to brushing on whole-mouth mean plaque and gingivitis measured at 2 weeks as well as a bleeding assessment according to the Bleeding Index at 2 and 4 weeks. A microbiological assessment will be performed to identify and quantify specific oral microbes to assess any change in population.
- Conditions
- Dental Plaque
- Being tested
- 19416-154-1, W002194-0221P
- Keywords
- Gingivitis, Microorganisms
- Medical subject headings
- Dental Plaque, Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
19416-154-1Device
Also called Not Marketed
0.15% ethyl lauroyl arginate HCl-containing mouthrinse
W002194-0221PDevice
Also called Not Marketed
5% hydroalcohol mouthrinse
| Study group | Role | What they receive |
|---|---|---|
| 0.15% ethyl lauroyl arginate HCl-containing mouthrinse | Experimental | Brush teeth as usual, followed immediately by rinsing with 20 mL of assigned 0.15% ethyl lauroyl arginate HCl-containing mouthrinse (19415-154-1) for 30 seconds - repeat twice daily for four weeks. Receives: Device: 19416-154-1 |
| 5% hydroalcohol mouthrinse | Sham comparator | Brush teeth as usual, followed immediately by rinsing with 20 mL of assigned 5% hydroalcohol mouthrinse (W002194-0221P) for 30 seconds - repeat twice daily for four weeks. Receives: Device: W002194-0221P |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whole-mouth Mean Modified Gingival Index (MGI)
Gingivitis was assessed by scoring inflammation on a 0-4 scale, according to the Modified Gingival Index (MGI) where 0=Normal and 4=Severe Inflammation.
Measured: 4 weeks
Whole-mouth Mean Plaque Index (PI)
Plaque was assessed on a scale of 0-5 using the Turesky modification of the Quigley-Hein Plaque Index, where 0=No plaque and 5=Plaque covering 2/3 or more of surface.
Measured: 4 weeks
Secondary outcomes (6)
Whole-mouth Mean Modified Gingival Index (MGI)
Gingivitis was assessed by scoring inflammation on a 0-4 scale, according to the Modified Gingival Index, where 0=Normal and 4=Severe Inflammation.
Measured: 2 weeks
Whole-mouth Mean Plaque Index (PI)
Plaque was assessed on a scale of 0-5 using the Turesky modification of the Quigley-Hein Plaque Index, where 0=No plaque and 5=Plaque covering 2/3 or more of surface.
Measured: 2 Weeks
Whole-mouth Mean Bleeding Index (BI)
Bleeding after periodontal probe was assessed by scores on a scale of 0-2 using the Gingival Bleeding Index (BI), where 0=Absence of Bleeding after 30 Seconds and 2=Immediate Bleeding.
Measured: 2 Weeks
Whole-mouth Mean Bleeding Index (BI)
Bleeding after periodontal probe was assessed by scores on a scale of 0-2 using the Gingival Bleeding Index (BI), where 0=Absence of Bleeding after 30 Seconds and 2=Immediate Bleeding.
Measured: 4 Weeks
Microbiological Assessments - Absolute Counts
An assay (a checkerboard DNA-DNA hybridization) was conducted to estimate the number of bacterial cells in collected plaque samples. First, the bacterial cells were lysed (split open) in solution. DNA from the bacteria was then detected using fluorescent probes for different bacterial species. The sensitivity of the assay was 10^4 cells and failure to detect a signal was recorded as zero. Signals were converted to absolute counts by comparison with the fluorescent signal of standards of known concentrations.
The following hybridized categories of bacteria were analyzed:
- Actinomyces species
- Purple complex
- Yellow complex
- Green complex
- Orange complex
- Red complex
- Other species
Measured: 4 weeks
Microbiological Assessments - LOG Counts
An assay (a checkerboard DNA-DNA hybridization) was conducted to estimate the number of bacterial cells in collected plaque samples. First, the bacterial cells were lysed (split open) in solution. DNA from the bacteria was then detected using fluorescent probes for different bacterial species. The sensitivity of the assay was 10^4 cells and failure to detect a signal was recorded as zero. Signals were converted to log counts by comparison with the fluorescent signal of standards of known concentrations.
The following hybridized categories of bacteria were analyzed:
- Actinomyces species
- Purple complex
- Yellow complex
- Green complex
- Orange complex
- Red complex
- Other species
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2011 (estimated)
- Study start1 Nov 2011
- Primary completion2 Dec 2011
- Study completion2 Dec 2011
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 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Consumer and Personal Products Worldwide
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marcelo Araujo, DDS, MS, PhD, Study director, Johnson & Johnson Consumer and Personal Products Worldwide
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01462110
- Sponsor's protocol ID
- LAEBBA0001
- Status last verified
- Mar 2020
- First submitted
- 26 Oct 2011
- Last updated
- 7 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Johnson \& Johnson Consumer Inc. has an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Anti-Plaque and Anti-Gingivitis Efficacy of One Experimental Mouthrinse Following a Baseline Oral Prophylaxis: A Four Week Study
- ClinicalTrials.gov ID
- NCT01462110
- Acronym / sponsor ID
- LAEBBA0001
- Conditions
- Dental Plaque
- Keywords
- Gingivitis, Microorganisms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Johnson & Johnson Consumer and Personal Products WorldwideIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2011 (actual)
- Primary completion
- 2 Dec 2011 (actual)
- Study completion
- 2 Dec 2011 (actual)
- First posted
- 31 Oct 2011 (estimated)
- Results
- Posted 23 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will test the idea that using an experimental mouth rinse after each time you brush your teeth will result in a healthier mouth than using the regular mouth rinse. Participants will be expected to avoid oral hygiene (like brushing teeth or using mouthwash) for at least 12 hours before each visit and will not be allowed to eat, drink or smoke for at least 4 hours before each visit.
At the first visit, the study will be explained to you in detail and you will be allowed to ask any questions you may have before signing a consent form. You will complete a medical/dental history and the dentist will examine your mouth, during which he will poke your gums and scrape some plaque off your teeth for testing. If you do not meet the requirements to continue in the trial, you will be told that you do not need to return for more testing.
If you meet requirements to continue, you will have an equal chance of being assigned to use either of the two mouth rinses being studied. You will be given a diary, toothbrush, toothpaste, and your assigned mouth rinse, with instructions on how they must be used.
You will be instructed not to use any unassigned oral care products and to follow your usual eating habits. You will be given appointments to return two times within the next four weeks. At those visits, the staff will check to make sure you're following the instructions and ask how you're feeling, and the dentist will do the same thing he did during the first visit.
Detailed description
The primary objective of this randomized, double-blind, single-center, controlled, parallel-designed clinical study is to determine the efficacy of an experimental mouth rinse on whole-mouth mean plaque and gingivitis scores as an adjunct to brushing after four weeks of use.
The secondary objectives will be to determine the efficacy of the an experimental mouth rinse as an adjunct to brushing on whole-mouth mean plaque and gingivitis measured at 2 weeks as well as a bleeding assessment according to the Bleeding Index at 2 and 4 weeks. A microbiological assessment will be performed to identify and quantify specific oral microbes to assess any change in population.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0.15% ethyl lauroyl arginate HCl-containing mouthrinse | Experimental | Device: 19416-154-1Brush teeth as usual, followed immediately by rinsing with 20 mL of assigned 0.15% ethyl lauroyl arginate HCl-containing mouthrinse (19415-154-1) for 30 seconds - repeat twice daily for four weeks. |
| 5% hydroalcohol mouthrinse | Sham comparator | Device: W002194-0221PBrush teeth as usual, followed immediately by rinsing with 20 mL of assigned 5% hydroalcohol mouthrinse (W002194-0221P) for 30 seconds - repeat twice daily for four weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Males and females at least 18 years of age and in good general health.
- Must display adequate oral hygiene (i.e., brush teeth daily and exhibit no signs of oral neglect).
- Volunteers must read, sign, and receive a copy of the Informed Consent Form after the nature of the study has been fully explained.
- Must be willing to use the products according to instructions and be available for appointments.
- Baseline dental measurements meet protocol-specified criteria.
Key exclusion criteria (4 listed)
- Lip, tongue, or other form of oral piercing.
- Fixed or removable orthodontic appliance (such as bridges, braces or dentures).
- Pregnancy or breast-feeding at any time during the trial.
- Any medical, dental or psychiatric condition, abnormality or history, or use of any product or drug, that (per protocol or in the opinion of the investigator) may increase the risk to the subject associated with trial participation or investigational product administration, or interfere with the interpretation of trial results.
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 |
|---|---|---|
| 19416-154-1Also: Not Marketed0.15% ethyl lauroyl arginate HCl-containing mouthrinse | Device | 0.15% ethyl lauroyl arginate HCl-containing mouthrinse |
| W002194-0221PAlso: Not Marketed5% hydroalcohol mouthrinse | Device | 5% hydroalcohol mouthrinse |
Primary outcome
Whole-mouth Mean Modified Gingival Index (MGI)
Time frame: 4 weeks
Gingivitis was assessed by scoring inflammation on a 0-4 scale, according to the Modified Gingival Index (MGI) where 0=Normal and 4=Severe Inflammation.
Whole-mouth Mean Plaque Index (PI)
Time frame: 4 weeks
Plaque was assessed on a scale of 0-5 using the Turesky modification of the Quigley-Hein Plaque Index, where 0=No plaque and 5=Plaque covering 2/3 or more of surface.
6 secondary outcomes
Whole-mouth Mean Modified Gingival Index (MGI)
Time frame: 2 weeks
Whole-mouth Mean Plaque Index (PI)
Time frame: 2 Weeks
Whole-mouth Mean Bleeding Index (BI)
Time frame: 2 Weeks
Whole-mouth Mean Bleeding Index (BI)
Time frame: 4 Weeks
Microbiological Assessments - Absolute Counts
Time frame: 4 weeks
Microbiological Assessments - LOG Counts
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Johnson \& Johnson Consumer Inc. has an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.
Related trials for Dental Plaque
Active, not recruitingPhase 3
A Study to Assess the Efficacy of Two Brushing Regimens in the Reduction of Established Dental Plaque and Gingivitis
Plaque, Gingivitis
Not yet recruiting
Effectiveness of Personalized Digital Oral Health Intervention in Patients With Fixed Orthodontic Appliances.
Oral Hygiene in Patients With Fixed Orthodontic Appliances, Dental Plaque
Not yet recruiting
Effect of Xylitol- Versus Erythritol-Sweetened Mints on Plaque ATP-Bioluminescence Readings
Dental Caries, Dental Plaque
Not yet recruitingObservational study
Plaque and Bleeding on Probing Around Implants Supporting Fixed Full-Arch Dental Prostheses
Peri-Implant Health
Not yet recruiting
Effectiveness of Oil Pulling Using Oils in Comparison With Mouthwash for Gingivitis
Gingivitis
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.
Marcelo Araujo, DDS, MS, PhD study director
Johnson & Johnson Consumer and Personal Products Worldwide
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 19416-154-1 and W002194-0221P in people with Dental Plaque, run by Johnson & Johnson Consumer and Personal Products Worldwide 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 4 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 7 Apr 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?
Yes. Results are posted in the registry (first posted 23 Mar 2020). 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?
Whole-mouth Mean Modified Gingival Index (MGI) (time frame: 4 weeks). 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?
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 7 Apr 2020.