GingivitisPhase 4NCT02065414
A Clinical Trial to Test the Effect of Experimental Mouth Rinse on Gum Disease
A Phase 4 study testing Listerine Advance Gum Defense, Mouth rinse containing Chlorhexidine and Mouth rinse containing 5% Hydroalcohol in people with Gingivitis, run by Johnson & Johnson Consumer and Personal Products Worldwide at 1 site in United Kingdom.
Trial summary
Participants will be given special instructions about taking care of their teeth during the 18 hours before they come to the dentist's office for screening/baseline, 1 week, 2 weeks and 4 weeks. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gingivitis
- What is being tested?
- Listerine Advance Gum Defense, Mouth rinse containing Chlorhexidine and Mouth rinse containing 5% Hydroalcohol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 260 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2014to Jun 2014
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. Males and females 18 years of age or older, in good general and oral health without any known allergy to commercial dental products or cosmetics.
- 2. Evidence of a personally signed and dated informed consent document indicating the subject (or legally acceptable representative) has been informed of all pertinent aspects of the trial and all questions have been answered.
- 3. Females of childbearing potential must be using a medically-acceptable method of birth control for at least 1 month prior to Visit 1 and agree to continue using this method during their participation in the study.
- 4. Able to comprehend and follow the requirements of the study (including availability on scheduled visit dates) based upon research site personnel's assessment.
- 5. A minimum of 20 natural teeth with scorable facial and lingual surfaces. Teeth that are grossly carious, extensively restored, orthodontically banded, abutments, exhibiting severe generalized cervical and/or enamel abrasion, or third molars will not be included in the tooth count.
- 6. A mean gingival index ≥1.75 according to the Modified Gingival Index.
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- 7. A mean plaque index ≥1.95 according to the Turesky modification of the Quigley-Hein Plaque Index scored on six surfaces per tooth.
- 8. Mean Bleeding Index ≥0.15
- 9. Absence of significant oral soft tissue pathology, excluding plaque-induced gingivitis, based on a visual examination and at the discretion of the Investigator.
- 10. Absence of moderate/advanced periodontitis based on a clinical examination (ADA Type III, IV).
- 11. Absence of fixed or removable orthodontic appliance or removable partial dentures.
Who cannot join
- 1. History of significant adverse effects, including sensitivities or suspected allergies, following use of oral hygiene products such as toothpastes and mouth rinses and red food dye.
- 2. Dental prophylaxis within 2 weeks prior to Screening visit.
- 3. History of medical conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures.
- 4. Antibiotic, anti-inflammatory or anticoagulant therapy during the study or within the one month prior to the baseline exam. Intermittent use of certain anti-inflammatory medication is acceptable at the discretion of the investigator.
- 5. Daily use of aspirin.
- 6. Known sensitivity to the investigational product ingredients.
Show all 11Show fewer
- 7. Self reported pregnancy or lactation (this criterion is due to oral tissue changes related to pregnancy and nursing which can affect interpretation of study results).
- 8. Significant unstable or uncontrolled medical condition which may interfere with a subject's participation in the study, at the discretion of the Investigator.
- 9. Participation in any clinical study within 30 days of Visit 1.
- 10. Relative, partner or staff of any clinical research site personnel.
- 11. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
National Research Ethics Committee Yorkshire & Humber-Sheffield
Chester, United Kingdom, M1 3DZ
About this study
Official title: Four Weeks Clinical Efficacy of an Ethyl Lauroyl Arginate HCL (LAE) Mouth Rinse: Effect on Gingivitis
Participants will be given special instructions about taking care of their teeth during the 18 hours before they come to the dentist's office for screening/baseline, 1 week, 2 weeks and 4 weeks. 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. Participants in all three groups will be given toothpaste that is already available in stores. They will brush their teeth twice daily in their regular manner. After brushing, participants 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 use a placebo mouth rinse. After they receive their assigned products participants will be supervised while they brush their teeth and rinse to ensure they understand exactly how to use the products. Participants will be required to stay at the site 20 minutes after the first use of product during visit 1 to monitor any potential allergic reaction. All other brushing and rinsing over the next four weeks will be at home, but participants will be required to keep a diary to record their brushing and rinsing times twice each day.
Read more
Participants will be required to bring their diaries and any left-over toothpaste and mouth rinse with them for three more scheduled appointments after about 1 week, 2 weeks, and 4 weeks. 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 bleeding as a result of gingivitis, and compare these results to the mouth rinse that is already available.
Read the detailed description
At screening Participants will present to the clinical site having refrained from oral hygiene for at least 8 hours, but no more than 18 hours for baseline examinations (safety oral and hard soft tissue exam, MGI - Modified Gingival Index, BI - Bleeding Index and PI- Plaque Index and Extrinsic Staining. After the baseline oral examinations, qualifying participants will receive a whole-mouth supragingival dental prophylaxis and will be randomly assigned to one of three treatment groups.
Participants randomly assigned to the negative control treatment group will brush twice daily with a marketed fluoride toothpaste in their usual manner and rinse with a placebo mouth rinse. Participants randomly assigned to the experimental treatment group will brush twice daily with a marketed fluoride toothpaste brush in their usual manner and use an experimental mouth rinse. The last treatment group randomly assigned to the positive control will brush twice daily with a marketed fluoride toothpaste in their usual manner and rinse with a marketed available mouth rinse. Participants will have an equal chance of being assigned each of the three groups. The first product use will be conducted under supervision of study personnel. Participants will be required to stay at the site 20 minutes after the first use of product during visit 1 to monitor any potential analytic reaction. All other brushing and rinsing will be unsupervised and the participants will be required to maintain a diary card to document twice-daily product use, brushing and rinsing times. Diaries along with product accountability will be used to check for subject compliance.
Participants will return to the clinical site after 1 week (Day 7±1 day), 2 weeks (Day 14±2 days) and 4 weeks (Day 28±3 days). Oral hard and soft tissue safety, Modified Gingival Index (MGI), Bleeding Index (BI), and Plaque Index (PI) will be assessed by the primary examiner 1 at all visits Extrinsic stain will be assessed at baseline, 2 weeks and 4 weeks by the secondary examiner.
At the end of the study, subjects will return all used and unused product to the clinical site.
- Conditions
- Gingivitis
- Being tested
- Listerine Advance Gum Defense, Mouth rinse containing Chlorhexidine, Mouth rinse containing 5% Hydroalcohol
- 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.
Listerine Advance Gum DefenseOther
Mouth rinse containing ChlorhexidineOther
Mouth rinse containing 5% HydroalcoholOther
| Study group | Role | What they receive |
|---|---|---|
| Neg Control Mouth Rinse W002194-0221-P | Placebo comparator | Mouth rinse containing 5% Hydroalcohol
Twice each day, brush in usual manner with a fluoride-containing dentifrice, rinse mouth with water, and then rinse with 20 ml of mouth rinse W002194-0221-P for 30 seconds and spit it out. Receives: Other: Mouth rinse containing 5% Hydroalcohol |
| Experimental: Mouth Rinse 19668-012 | Experimental | Listerine Advance Gum Defense Twice each day, brush in usual manner with a fluoride-containing dentifrice, 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: Other: Listerine Advance Gum Defense |
| Active Comparator Mouth Rinse 5000347078873 | Active comparator | Mouth rinse containing Chlorhexidine Corsodyl ®Mouthwash
Twice each day, brush in usual manner with a fluoride-containing dentifrice, in the usual manner, rinse mouth with water, wait 5 minutes after brushing and then rinse with 10 ml of mouth rinse 5000347078873for 60 seconds and spit it out - do not swallow. Receives: Other: Mouth rinse containing Chlorhexidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whole Mouth Mean Bleeding Index (BI) at 4 weeks
Bleeding will be assessed by using a standard measurement called the Gingival Bleeding Index.
Measured: 4 weeks
Secondary outcomes (4)
Whole Mouth Mean Bleeding Index (BI) at 1 week
Bleeding will be assessed by using a standard measurement called the Gingival Bleeding Index
Measured: Within 2 weeks
Whole-mouth Mean Modified Gingival Index (MGI)
Gingivitis will be assessed by scoring inflammation according to the Modified Gingival Index.
Measured: Within 4 weeks
Turesky Modification of the Quigley Hein Plaque Index (PI)
Plaque will be assessed using a standard scale called the Turesky Modification of the Quigley Hein Plaque Index
Measured: Within 4 weeks
Extrinsic Stain
Stain will be assessed using the standard measurement called Macpherson Modification of the Lobene Stain Index
Measured: Within 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2014 (estimated)
- Study startMar 2014
- Primary completionJun 2014
- Study completionJun 2014
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 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Consumer and Personal Products Worldwide
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Lynch, DMD, PhD, Study director, Johnson & Johnson Consumer and Personal Products Worldwide
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02065414
- Sponsor's protocol ID
- LAEBBA0005
- Status last verified
- Sep 2014
- First submitted
- 16 Feb 2014
- Last updated
- 5 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Four Weeks Clinical Efficacy of an Ethyl Lauroyl Arginate HCL (LAE) Mouth Rinse: Effect on Gingivitis
- ClinicalTrials.gov ID
- NCT02065414
- Acronym / sponsor ID
- LAEBBA0005
- Conditions
- Gingivitis
- Keywords
- Gums, Gingiva, Gingival Inflammation, Gingival Bleeding
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Johnson & Johnson Consumer and Personal Products WorldwideIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 19 Feb 2014 (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.
Participants will be given special instructions about taking care of their teeth during the 18 hours before they come to the dentist's office for screening/baseline, 1 week, 2 weeks and 4 weeks. 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. Participants in all three groups will be given toothpaste that is already available in stores. They will brush their teeth twice daily in their regular manner. After brushing, participants 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 use a placebo mouth rinse. After they receive their assigned products participants will be supervised while they brush their teeth and rinse to ensure they understand exactly how to use the products. Participants will be required to stay at the site 20 minutes after the first use of product during visit 1 to monitor any potential allergic reaction. All other brushing and rinsing over the next four weeks will be at home, but participants will be required to keep a diary to record their brushing and rinsing times twice each day.
Participants will be required to bring their diaries and any left-over toothpaste and mouth rinse with them for three more scheduled appointments after about 1 week, 2 weeks, and 4 weeks. 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 bleeding as a result of gingivitis, and compare these results to the mouth rinse that is already available.
Detailed description
At screening Participants will present to the clinical site having refrained from oral hygiene for at least 8 hours, but no more than 18 hours for baseline examinations (safety oral and hard soft tissue exam, MGI - Modified Gingival Index, BI - Bleeding Index and PI- Plaque Index and Extrinsic Staining. After the baseline oral examinations, qualifying participants will receive a whole-mouth supragingival dental prophylaxis and will be randomly assigned to one of three treatment groups.
Participants randomly assigned to the negative control treatment group will brush twice daily with a marketed fluoride toothpaste in their usual manner and rinse with a placebo mouth rinse. Participants randomly assigned to the experimental treatment group will brush twice daily with a marketed fluoride toothpaste brush in their usual manner and use an experimental mouth rinse. The last treatment group randomly assigned to the positive control will brush twice daily with a marketed fluoride toothpaste in their usual manner and rinse with a marketed available mouth rinse. Participants will have an equal chance of being assigned each of the three groups. The first product use will be conducted under supervision of study personnel. Participants will be required to stay at the site 20 minutes after the first use of product during visit 1 to monitor any potential analytic reaction. All other brushing and rinsing will be unsupervised and the participants will be required to maintain a diary card to document twice-daily product use, brushing and rinsing times. Diaries along with product accountability will be used to check for subject compliance.
Participants will return to the clinical site after 1 week (Day 7±1 day), 2 weeks (Day 14±2 days) and 4 weeks (Day 28±3 days). Oral hard and soft tissue safety, Modified Gingival Index (MGI), Bleeding Index (BI), and Plaque Index (PI) will be assessed by the primary examiner 1 at all visits Extrinsic stain will be assessed at baseline, 2 weeks and 4 weeks by the secondary examiner.
At the end of the study, subjects will return all used and unused product to the clinical site.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Neg Control Mouth Rinse W002194-0221-P | Placebo comparator | Other: Mouth rinse containing 5% HydroalcoholMouth rinse containing 5% Hydroalcohol Twice each day, brush in usual manner with a fluoride-containing dentifrice, rinse mouth with water, and then rinse with 20 ml of mouth rinse W002194-0221-P for 30 seconds and spit it out. |
| Experimental: Mouth Rinse 19668-012 | Experimental | Other: Listerine Advance Gum DefenseListerine Advance Gum Defense Twice each day, brush in usual manner with a fluoride-containing dentifrice, 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. |
| Active Comparator Mouth Rinse 5000347078873 | Active comparator | Other: Mouth rinse containing ChlorhexidineMouth rinse containing Chlorhexidine Corsodyl ®Mouthwash Twice each day, brush in usual manner with a fluoride-containing dentifrice, in the usual manner, rinse mouth with water, wait 5 minutes after brushing and then rinse with 10 ml of mouth rinse 5000347078873for 60 seconds and spit it out - do not swallow. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 1. Males and females 18 years of age or older, in good general and oral health without any known allergy to commercial dental products or cosmetics.
- 2. Evidence of a personally signed and dated informed consent document indicating the subject (or legally acceptable representative) has been informed of all pertinent aspects of the trial and all questions have been answered.
- 3. Females of childbearing potential must be using a medically-acceptable method of birth control for at least 1 month prior to Visit 1 and agree to continue using this method during their participation in the study.
- 4. Able to comprehend and follow the requirements of the study (including availability on scheduled visit dates) based upon research site personnel's assessment.
- 5. A minimum of 20 natural teeth with scorable facial and lingual surfaces. Teeth that are grossly carious, extensively restored, orthodontically banded, abutments, exhibiting severe generalized cervical and/or enamel abrasion, or third molars will not be included in the tooth count.
Key exclusion criteria (11 listed)
- 1. History of significant adverse effects, including sensitivities or suspected allergies, following use of oral hygiene products such as toothpastes and mouth rinses and red food dye.
- 2. Dental prophylaxis within 2 weeks prior to Screening visit.
- 3. History of medical conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures.
- 4. Antibiotic, anti-inflammatory or anticoagulant therapy during the study or within the one month prior to the baseline exam. Intermittent use of certain anti-inflammatory medication is acceptable at the discretion of the investigator.
- 5. Daily use of aspirin.
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 |
|---|---|---|
| Listerine Advance Gum Defense | Other | Experimental: Mouth Rinse 19668-012 |
| Mouth rinse containing Chlorhexidine | Other | Active Comparator Mouth Rinse 5000347078873 |
| Mouth rinse containing 5% Hydroalcohol | Other | Neg Control Mouth Rinse W002194-0221-P |
Primary outcome
Whole Mouth Mean Bleeding Index (BI) at 4 weeks
Time frame: 4 weeks
Bleeding will be assessed by using a standard measurement called the Gingival Bleeding Index.
4 secondary outcomes
Whole Mouth Mean Bleeding Index (BI) at 1 week
Time frame: Within 2 weeks
Whole-mouth Mean Modified Gingival Index (MGI)
Time frame: Within 4 weeks
Turesky Modification of the Quigley Hein Plaque Index (PI)
Time frame: Within 4 weeks
Extrinsic Stain
Time frame: Within 4 weeks
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 5 Sep 2014.
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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 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 Phase 4 study testing Listerine Advance Gum Defense, Mouth rinse containing Chlorhexidine and Mouth rinse containing 5% Hydroalcohol in people with Gingivitis, run by Johnson & Johnson Consumer and Personal Products Worldwide at 1 site in United Kingdom.
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 11 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 5 Sep 2014. 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 Kingdom. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Whole Mouth Mean Bleeding Index (BI) at 4 weeks (time frame: 4 weeks). 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 5 Sep 2014.