GingivitisNCT01821261
A Clinical Trial to Test the Effect of an Experimental Mouth Rinse on Gum Disease
A study testing Mouth Rinse 19668-012, Mouth Rinse 500347078842 and Toothpaste 035000513007 in people with Gingivitis, run by Johnson & Johnson Consumer Inc. (J&JCI).
Trial summary
Subjects will be given special instructions about eating, smoking and taking care of their teeth during the 18 hours before they come to the dentist's office for screening. At that first visit, they will be examined by a dentist, who will examine their mouths with a dental instrument to determine whether they qualify… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gingivitis
- What is being tested?
- Mouth Rinse 19668-012, Mouth Rinse 500347078842 and Toothpaste 035000513007
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 30 Apr 2014to 31 Jul 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Assessed by site personnel as able to comprehend and follow the requirements of the study in the Portuguese language, and to be available on scheduled visit dates
- After being informed of all pertinent aspects of the trial, and having all questions answered, voluntarily signed an informed consent document
- Assessed by the investigator to have gingivitis, and otherwise qualify to be a participant in the trial
Who cannot join
- Relative, partner or staff of any clinical research site personnel
- Any oral, psychiatric or medical condition (including pregnancy or nursing), laboratory abnormality, or use of experimental or other products that may (per protocol or in the opinion of the investigator) compromise the safety of the participant or the interpretation of study results
About this study
Official title: Three Month Clinical Efficacy of an Ethyl Lauroyl Arginate HCL (LAE) Mouth Rinse: Effect on Gingivitis
Subjects will be given special instructions about eating, smoking and taking care of their teeth during the 18 hours before they come to the dentist's office for screening. At that first visit, they will be examined by a dentist, who will examine their mouths with a dental instrument to determine whether they qualify to participate in the trial. Someone who works for the dentist will also take some oral measurements.
Participants who qualify to be in the study will receive a treatment for their gingivitis and have an equal chance of being assigned to one of three treatment groups. Subjects in all three groups will be given toothpaste that is already available in stores. They will brush their teeth twice daily with a one-inch strip of toothpaste in their regular manner. After brushing, subjects in one group will use an experimental mouth rinse that is not available in stores. Another group will be given a mouth rinse to use that is already available in stores, and the third group will not use any mouth rinse at all. After they receive their assigned products subjects will be supervised while they brush their teeth and/or rinse to ensure they understand exactly how to use the products. All other brushing and rinsing over the next three months will be at home, but subjects will be required to keep a diary to record their brushing and rinsing times twice each day.
Read more
Subjects will be required to bring their diaries and any leftover toothpaste and mouth rinse with them for four more scheduled appointments after about 1 week, 2 weeks, 4 weeks, and 3 months. At those appointments, the dentist will examine their mouths, make sure there are no safety concerns, and examine again to get the measurements needed. One of the dentist's staff members will take other measurements as well.
The study will determine the measured effects of the experimental mouth rinse on gingivitis, and compare these results to the mouth rinse that is already available, as well as to using no mouth rinse at all.
Read the detailed description
At screening/baseline, subjects will present to the clinical site having refrained from oral hygiene for at least 8 hours, but no more than 18 hours, and from eating or smoking for at least 4 hours for baseline examinations. Baseline examinations will include Macpherson modification of the Lobene Stain Index (Extrinsic Stain), Volpe-Manhold Index (Calculus), and oral hard and soft tissue exam, Modified Gingival Index (MGI), Bleeding Index (BI) and Plaque Index (PI). After the baseline oral examinations, subjects who qualify will receive a whole-mouth supragingival dental prophylaxis and random assignment to one of three treatment groups.
Subjects randomized to the control group will brush twice daily with a marketed fluoride toothpaste. Subjects randomized to the experimental group will brush twice daily with a marketed fluoride toothpaste and use an experimental mouth rinse. The last randomized group will brush twice daily with a marketed fluoride toothpaste and rinse with a marketed mouth rinse twice daily. The first product use will be conducted under supervision of study personnel. All other brushing and rinsing will be unsupervised and the subjects will be required to maintain a diary card to document twice-daily product use, with brushing and rinsing times. Diaries along with product accountability will be used to check for subject compliance.
Subjects will return to the clinical site after one week (Day 7±1 day), two weeks (Day 14±2 days), four weeks (Day 28±3 days) and three months (Day 91±5 days). Oral hard and soft tissue safety, MGI, BI, and PI will be assessed at all visits. Extrinsic Stain and Calculus will be assessed at baseline, four weeks and three months by a different examiner.
At the end of the study, subjects will return all used and unused product to the clinical site.
- Conditions
- Gingivitis
- Being tested
- Mouth Rinse 19668-012, Mouth Rinse 500347078842, Toothpaste 035000513007
- Keywords
- Gums, Gingiva, Gingival Inflammation, Gingival Bleeding
- Medical subject headings
- Gingivitis, Gingival Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mouth Rinse 19668-012Device
20 ml of experimental mouth rinse 19668-012 for 30 seconds, twice daily
Mouth Rinse 500347078842Drug
Also called Mouth rinse containing Chlorhexidine, Corsodyl Mouthwash
10 ml of mouth rinse 500347078842 for 60 seconds, twice daily
Toothpaste 035000513007Drug
Also called Toothpaste containing fluoride, Colgate® Cavity Protection Regular
Approximately one inch of toothpaste 035000513007, twice daily
| Study group | Role | What they receive |
|---|---|---|
| Mouth Rinse 19668-012 | Experimental | Twice each day, brush with about one inch of toothpaste 035000513007 in the usual manner, rinse mouth with water, and then rinse with 20 ml of mouth rinse 19668-012 for 30 seconds and spit it out - do not swallow. Receives: Device: Mouth Rinse 19668-012; Drug: Toothpaste 035000513007 |
| Mouth Rinse 500347078842 | Active comparator | Twice each day, brush with about one inch of toothpaste 035000513007 in the usual manner, rinse mouth with water, and then rinse with 10 ml of mouth rinse 500347078842 for 60 seconds and spit it out - do not swallow.
Attention: Toothpastes can stop mouth rinse from working. Rinse your mouth thoroughly with water and wait 5 minutes after brushing your teeth before using the mouth rinse. You can also use the mouthwash at a different time of day. Receives: Drug: Mouth Rinse 500347078842; Drug: Toothpaste 035000513007 |
| Toothpaste 035000513007 | Other | Twice each day, brush with about one inch of toothpaste 035000513007 in the usual manner. Subjects in this arm will not use any mouth rinse. Receives: Drug: Toothpaste 035000513007 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whole-mouth Mean Bleeding Index (BI) at 3 Months
Bleeding after periodontal probe will be 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: 3 months
Secondary outcomes (9)
Whole-mouth Mean Bleeding Index (BI)
Bleeding after periodontal probe will be 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: within 4 weeks
Whole-mouth Mean Modified Gingival Index (MGI)
Gingivitis will be assessed by scoring inflammation on a 0-4 scale, according to the Modified Gingival Index, where 0=Normal and 4=Severe Inflammation.
Measured: within 3 months
Whole Mouth Mean Plaque Index (PI)
Plaque will be 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: within 3 months
Mean Area Stain Score for Mesial Region
A mean area stain score for the Mesial Region will be recorded on a scale of 0-3, where 0 = no stain present, natural tooth color and 3 = stain outside pits/grooves, over 10% of surface affected
Measured: within 3 months
Mean Area Stain Score for Gingival Region
A mean area stain score will be recorded for Gingival Region, on a scale of 0-3, where 0 = no stain present, natural tooth color and 3 = stain outside pits/grooves, over 10% of surface affected
Measured: within 3 months
Mean Area Stain Score for Distal Region
A mean area stain score will be recorded for Distal Region, on a scale of 0-3, where 0 = no stain present, natural tooth color and 3 = stain outside pits/grooves, over 10% of surface affected
Measured: within 3 months
Mean Area Stain Score for Body of Tooth
Mean area stain scores will be recorded for Body of Tooth, on a scale of 0-3, where 0 = no stain present, natural tooth color and 3 = stain outside pits/grooves, over 10% of surface affected
Measured: within 3 months
Mean Stain Intensity Score
A score for stain intensity will be recorded on a scale of 0-3, where 0 = no stain and 3 = heavy, dark stain (obvious and aesthetically unacceptable)
Measured: within 3 months
Mean Tartar Height
Mean tartar height will be recorded in millimeters
Measured: within 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2013 (estimated)
- Study start30 Apr 2014
- Primary completion30 Apr 2014 (estimated)
- Study completion31 Jul 2014 (estimated)
Why it stopped: Business Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GingivitisStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Consumer Inc. (J&JCI)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Lynch, DMD, PhD, Study director, Johnson & Johnson Consumer Inc. (J&JCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01821261
- Sponsor's protocol ID
- LAEBBA0004
- Status last verified
- Jan 2019
- First submitted
- 22 Mar 2013
- Last updated
- 28 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three Month Clinical Efficacy of an Ethyl Lauroyl Arginate HCL (LAE) Mouth Rinse: Effect on Gingivitis
- ClinicalTrials.gov ID
- NCT01821261
- Acronym / sponsor ID
- LAEBBA0004
- Conditions
- Gingivitis
- Keywords
- Gums, Gingiva, Gingival Inflammation, Gingival Bleeding
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Business Decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johnson & Johnson Consumer Inc. (J&JCI)Industry (pharma, biotech, devices)
- Study start
- 30 Apr 2014 (actual)
- Primary completion
- 30 Apr 2014 (estimated)
- Study completion
- 31 Jul 2014 (estimated)
- First posted
- 29 Mar 2013 (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.
Subjects will be given special instructions about eating, smoking and taking care of their teeth during the 18 hours before they come to the dentist's office for screening. At that first visit, they will be examined by a dentist, who will examine their mouths with a dental instrument to determine whether they qualify to participate in the trial. Someone who works for the dentist will also take some oral measurements.
Participants who qualify to be in the study will receive a treatment for their gingivitis and have an equal chance of being assigned to one of three treatment groups. Subjects in all three groups will be given toothpaste that is already available in stores. They will brush their teeth twice daily with a one-inch strip of toothpaste in their regular manner. After brushing, subjects in one group will use an experimental mouth rinse that is not available in stores. Another group will be given a mouth rinse to use that is already available in stores, and the third group will not use any mouth rinse at all. After they receive their assigned products subjects will be supervised while they brush their teeth and/or rinse to ensure they understand exactly how to use the products. All other brushing and rinsing over the next three months will be at home, but subjects will be required to keep a diary to record their brushing and rinsing times twice each day.
Subjects will be required to bring their diaries and any leftover toothpaste and mouth rinse with them for four more scheduled appointments after about 1 week, 2 weeks, 4 weeks, and 3 months. At those appointments, the dentist will examine their mouths, make sure there are no safety concerns, and examine again to get the measurements needed. One of the dentist's staff members will take other measurements as well.
The study will determine the measured effects of the experimental mouth rinse on gingivitis, and compare these results to the mouth rinse that is already available, as well as to using no mouth rinse at all.
Detailed description
At screening/baseline, subjects will present to the clinical site having refrained from oral hygiene for at least 8 hours, but no more than 18 hours, and from eating or smoking for at least 4 hours for baseline examinations. Baseline examinations will include Macpherson modification of the Lobene Stain Index (Extrinsic Stain), Volpe-Manhold Index (Calculus), and oral hard and soft tissue exam, Modified Gingival Index (MGI), Bleeding Index (BI) and Plaque Index (PI). After the baseline oral examinations, subjects who qualify will receive a whole-mouth supragingival dental prophylaxis and random assignment to one of three treatment groups.
Subjects randomized to the control group will brush twice daily with a marketed fluoride toothpaste. Subjects randomized to the experimental group will brush twice daily with a marketed fluoride toothpaste and use an experimental mouth rinse. The last randomized group will brush twice daily with a marketed fluoride toothpaste and rinse with a marketed mouth rinse twice daily. The first product use will be conducted under supervision of study personnel. All other brushing and rinsing will be unsupervised and the subjects will be required to maintain a diary card to document twice-daily product use, with brushing and rinsing times. Diaries along with product accountability will be used to check for subject compliance.
Subjects will return to the clinical site after one week (Day 7±1 day), two weeks (Day 14±2 days), four weeks (Day 28±3 days) and three months (Day 91±5 days). Oral hard and soft tissue safety, MGI, BI, and PI will be assessed at all visits. Extrinsic Stain and Calculus will be assessed at baseline, four weeks and three months by a different examiner.
At the end of the study, subjects will return all used and unused product to the clinical site.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mouth Rinse 19668-012 | Experimental | Device: Mouth Rinse 19668-012, Drug: Toothpaste 035000513007Twice each day, brush with about one inch of toothpaste 035000513007 in the usual manner, rinse mouth with water, and then rinse with 20 ml of mouth rinse 19668-012 for 30 seconds and spit it out - do not swallow. |
| Mouth Rinse 500347078842 | Active comparator | Drug: Mouth Rinse 500347078842, Drug: Toothpaste 035000513007Twice each day, brush with about one inch of toothpaste 035000513007 in the usual manner, rinse mouth with water, and then rinse with 10 ml of mouth rinse 500347078842 for 60 seconds and spit it out - do not swallow. Attention: Toothpastes can stop mouth rinse from working. Rinse your mouth thoroughly with water and wait 5 minutes after brushing your teeth before using the mouth rinse. You can also use the mouthwash at a different time of day. |
| Toothpaste 035000513007 | Other | Drug: Toothpaste 035000513007Twice each day, brush with about one inch of toothpaste 035000513007 in the usual manner. Subjects in this arm will not use any mouth rinse. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Assessed by site personnel as able to comprehend and follow the requirements of the study in the Portuguese language, and to be available on scheduled visit dates
- After being informed of all pertinent aspects of the trial, and having all questions answered, voluntarily signed an informed consent document
- Assessed by the investigator to have gingivitis, and otherwise qualify to be a participant in the trial
Key exclusion criteria (2 listed)
- Relative, partner or staff of any clinical research site personnel
- Any oral, psychiatric or medical condition (including pregnancy or nursing), laboratory abnormality, or use of experimental or other products that may (per protocol or in the opinion of the investigator) compromise the safety of the participant or the interpretation of study 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 |
|---|---|---|
| Mouth Rinse 19668-01220 ml of experimental mouth rinse 19668-012 for 30 seconds, twice daily | Device | Mouth Rinse 19668-012 |
| Mouth Rinse 500347078842Also: Mouth rinse containing Chlorhexidine, Corsodyl Mouthwash10 ml of mouth rinse 500347078842 for 60 seconds, twice daily | Drug | Mouth Rinse 500347078842 |
| Toothpaste 035000513007Also: Toothpaste containing fluoride, Colgate® Cavity Protection RegularApproximately one inch of toothpaste 035000513007, twice daily | Drug | Mouth Rinse 19668-012, Mouth Rinse 500347078842, Toothpaste 035000513007 |
Primary outcome
Whole-mouth Mean Bleeding Index (BI) at 3 Months
Time frame: 3 months
Bleeding after periodontal probe will be 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.
9 secondary outcomes
Whole-mouth Mean Bleeding Index (BI)
Time frame: within 4 weeks
Whole-mouth Mean Modified Gingival Index (MGI)
Time frame: within 3 months
Whole Mouth Mean Plaque Index (PI)
Time frame: within 3 months
Mean Area Stain Score for Mesial Region
Time frame: within 3 months
Mean Area Stain Score for Gingival Region
Time frame: within 3 months
Mean Area Stain Score for Distal Region
Time frame: within 3 months
Mean Area Stain Score for Body of Tooth
Time frame: within 3 months
Mean Stain Intensity Score
Time frame: within 3 months
Mean Tartar Height
Time frame: within 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2019.
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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.
Michael Lynch, DMD, PhD study director
Johnson & Johnson Consumer Inc. (J&JCI)
Questions about this trial
What is this clinical trial studying?
A study testing Mouth Rinse 19668-012, Mouth Rinse 500347078842 and Toothpaste 035000513007 in people with Gingivitis, run by Johnson & Johnson Consumer Inc. (J&JCI).
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 3 inclusion and 2 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: withdrawn, as of the sponsor's last update on 28 Jan 2019. 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. 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 was withdrawn before enrolling participants, so there are no results.
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 Bleeding Index (BI) at 3 Months (time frame: 3 months). 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 28 Jan 2019.