PlaqueNCT02233998
A Clinical Trial to Test the Effect of Marketed Mouth Rinses on Decreasing Plaque and Gum Inflammation
A study testing Mouth Rinse 1, Mouth Rinse 2 and Mouth Rinse 3 in people with Plaque and Gingivitis, run by Johnson & Johnson Consumer and Personal Products Worldwide at 1 site in Canada.
Trial summary
The reduction of existing plaque and gum inflammation will be evaluated using two marketed mouth rinses along with tooth brushing after 21 days of use compared to a placebo mouth rinse. 165 healthy volunteers will be enrolled in this three week study. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Plaque, Gingivitis
- What is being tested?
- Mouth Rinse 1, Mouth Rinse 2 and Mouth Rinse 3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 158 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2014to Sep 2014
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able to comprehend and follow the requirements of the study (including availability on scheduled visit dates) based upon research site personnel's assessment;
- 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;
- Males and females 18 years of age or older, in good general and oral health without any known allergy to commercial dental products;
- 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;
- A mean gingival index ≥ 1.95 according to the Modified Gingival Index;
- A mean plaque index ≥ 1.95 according to the Turesky modification of the Quigley-Hein Plaque Index scored on six surfaces per tooth;
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- Absence of significant oral soft tissue pathology, excluding plaque-induced gingivitis, based on a visual examination and at the discretion of the Investigator;
- Absence of moderate/advanced periodontitis based on a clinical examination (ADA Type III, IV).
- Absence of fixed or removable orthodontic appliance or removable partial dentures;
- Able to read and understand the local language;
- Male or non-pregnant, non-lactating female, by self-report;
- Male and female subjects with reproductive potential must agree to practice a medically acceptable form of birth control during the study and for 30 days following the last dose of investigational product. Females must have used such birth control for at least 3 months prior to the Baseline visit.
- Medically acceptable forms of birth control that may be used by the subject and/or his/her partner include:
- Abstinence from reproductive intercourse when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptom-thermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception;
- Established use of hormonal methods of contraception (oral, injected, implanted, patch or vaginal ring);
- Intrauterine device (IUD) or intrauterine system (IUS);
- Barrier methods of contraception with spermicide: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository;
- Surgical sterilization (e.g., vasectomy that has been confirmed effective by sperm count check, tubal occlusion, hysterectomy, bilateral salpingectomy); and
- A female subject who is postmenopausal (i.e., amenorrheic for at least 12 months prior to the Baseline visit) is not considered of reproductive potential.
- Willing for this to be the only investigational product used during this time period; and
- Willing and able to comply with all study procedures and attend the scheduled visits for the duration of the study.
Who cannot join
- Subjects presenting with any of the following will not be included in the study:
- 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;
- Dental prophylaxis within 2 weeks prior to Screening visit;
- Antibiotic, anti-inflammatory or anticoagulant therapy during the study or within one month prior to the baseline exam;
- Regular use of chemotherapeutic antiplaque/antigingivitis products such as triclosan, essential oil, cetylpyridinium chloride, or chlorhexidine containing mouth rinses within three weeks prior to baseline;
- 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);
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- Significant unstable or uncontrolled medical condition which may interfere with a subject's participation in the study, at the discretion of the Investigator;
- Participation in any other clinical study within 30 days of Visit 1;
- Subjects who are related to those persons involved directly or indirectly with the conduct of this study (i.e., principal investigator, sub-investigators, study coordinators, other site personnel, employees of Johnson \& Johnson subsidiaries, contractors of Johnson \& Johnson, and the families of each); and
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation, substance or alcohol abuse or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 21 Day Clinical Efficacy of Essential Oil Containing Mouth Rinses: Effect on Reducing Existing Gingivitis and Plaque
The reduction of existing plaque and gum inflammation will be evaluated using two marketed mouth rinses along with tooth brushing after 21 days of use compared to a placebo mouth rinse.
165 healthy volunteers will be enrolled in this three week study. Volunteers who qualify to be in this study will have an equal chance of being assigned to one of the three treatment groups. Volunteers will have a total of three visits including 1) Screening/Baseline Day 1 2) Day 11 (after 10 days of use) and 3) Day 22 (after 21 days of use). Volunteers will maintain a diary at home to record each treatment use and will be asked to come to the clinic without brushing or use their product for at least 8 hours, but no more than 18 hours. Examinations for oral hard/soft tissue, gingivitis, bleeding and plaque assessments will be completed at Screening/Baseline and repeated at Clinic Visit 3, which is Day 22.
Read the detailed description
A sufficient number of generally healthy subjects (approximately 165) that meet the required inclusion/exclusion criteria will be enrolled in this 21 day, examiner-blind, single center, randomized, parallel-group controlled clinical trial to ensure that at least 150 subjects (50 per treatment group) complete this study.
At baseline, the prescreened subjects will present to the clinic site for baseline examinations (oral tissue assessment, gingivitis, bleeding and plaque assessments) having refrained from oral hygiene for at least 8 hours, but no more than 18 hours. After the baseline oral examinations, assessment of other inclusion/exclusion criteria qualifying subjects will be randomly assigned to one of three treatment groups. Immediately following this randomization, subjects will begin use of their assigned test product following the label instructions. If randomized to the control group, subjects will brush twice daily in their usual manner with an ADA accepted fluoride toothpaste and a soft bristled toothbrush followed by rinsing twice daily with a 5% hydroalcohol control rinse (W002194-221P). If randomized to an active treatment group; subjects will brush twice daily in their usual manner, followed by rinsing twice daily with their assigned mouth rinse formulation (19292-116A or 11965-059). Subjects will be instructed to follow label instructions 20ml for 30 seconds twice daily for mouth rinse product. The first product use will be conducted under the 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, brushing and rinsing times. Compliance will be evaluated by weighing residual volumes of returned mouth rinse and by reviewing the subject diary. Subjects will receive an ADA- accepted fluoride-containing dentifrice and a soft bristled toothbrush at their baseline visit.
Subjects may continue to use floss to remove impacted food between the teeth if it is part of their usual oral care regimen during the course of the study; no other oral hygiene procedures will be permitted, including teeth cleaning, whitening or dental procedures except for an emergency treatment. The decision to withdraw a subject due to emergency dental treatment will occur at the discretion of the Investigator.
At baseline and three weeks (±2 days) visits, subject will not have brushed or have used their product for at least 8 hours, but no more than 18 hours.
Oral tissue safety, Modified Gingival Index (MGI), Bleeding Index (BI), and Plaque Index (PI) will be assessed.
- Conditions
- Plaque, Gingivitis
- Being tested
- Mouth Rinse 1, Mouth Rinse 2, Mouth Rinse 3
- Keywords
- Plaque, Bleeding, Gums, Gingiva, Gingival Inflammation, Gingival Bleeding
- Medical subject headings
- Plaque, Amyloid, Gingivitis, Hemorrhage, Gingival Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mouth Rinse 1Other
Also called Cool Mint Listerine Antiseptic
Mouth Rinse 2Other
Also called Listerine Zero
Mouth Rinse 3Other
Also called Placebo
| Study group | Role | What they receive |
|---|---|---|
| Mouth Rinse 1 | Active comparator | After brushing in your normal manner, rinse full strength twice a day with 20 mL for 30 seconds. Receives: Other: Mouth Rinse 1 |
| Mouth Rinse 2 | Active comparator | After brushing in your normal manner, rinse full strength twice a day with 20 mL for 30 seconds. Receives: Other: Mouth Rinse 2 |
| Mouth Rinse 3 | Placebo comparator | After brushing in your normal manner, rinse full strength twice a day with 20 mL for 30 seconds. Receives: Other: Mouth Rinse 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whole Mouth Mean Modified Gingival Index (MGI) at Week 3
Gingivitis was assessed on the buccal and lingual marginal gingivae and interdental papillae of all scorable teeth according to the following scale: 0: Normal (absence of inflammation), 1: Mild inflammation (slight change in color, little change in texture) of any portion of the gingival unit, 2: Mild inflammation of the entire gingival unit, 3: Moderate inflammation (moderate glazing, redness, edema, and/or hypertrophy) of the gingival unit, and 4: Severe inflammation marked redness, edema and/ or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration. The score for each participant was calculated by averaging their tooth site scores at Week 3.
Measured: 3 Weeks
Whole Mouth Mean Plaque Index (PI) at Week 3
Plaque area was measured based on the Turesky modification of the Quigley-Hein Plaque Index and was scored on six surfaces (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual, and mesiolingual) of all scorable teeth, following disclosing, according to the following scale: 0: No plaque, 1: Separate flecks or discontinuous band of plaque at the gingival (cervical) margin, 2: Thin (up to 1 mm), continuous band of plaque at the gingival margin, 3: Band of plaque wider than 1 mm but less than 1/3 of surface, 4: Plaque covering 1/3 or more, but less than 2/3 of surface, 5: Plaque covering 2/3 or more of surface. The score for each participant was calculated by averaging their tooth site scores at Week 3.
Measured: 3 Weeks
Secondary outcomes (7)
Whole Mouth Mean Gingival Bleeding Index (BI) at Week 3
Bleeding was assessed using a periodontal probe with a 0.5 mm diameter tip which was inserted into the gingival crevice, and swept from distal to mesial, around the tooth at an angle of approximately 60 degrees, while in contact with the sulcular epithelium. Each of 4 gingival areas (disto-buccal, midbuccal, mid-lingual, and mesio-lingual) around each tooth was assessed. After approximately 30 seconds, bleeding at each gingival unit was recorded according to the following scale: 0: Absence of bleeding after 30 seconds, 1: Bleeding after 30 seconds, and 2: Immediate bleeding. The score for each participant was calculated by averaging their tooth site scores at Week 3.
Measured: 3 Weeks
Change From Baseline in the Percentage of Healthy Sites (Modified Gingival Index (MGI) Scores of 0 or 1) at Week 3
Gingivitis was assessed on the buccal and lingual marginal gingivae and interdental papillae of all scorable teeth according to the following scale: 0: Normal (absence of inflammation), 1: Mild inflammation (slight change in color, little change in texture) of any portion of the gingival unit, 2: Mild inflammation of the entire gingival unit, 3: Moderate inflammation (moderate glazing, redness, edema, and/or hypertrophy) of the gingival unit, and 4: Severe inflammation marked redness, edema and/ or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration. The score for each participant was the change from baseline in the percentage of sites with an MGI score of 0 or 1 at Week 3.
Measured: Baseline to 3 Weeks
Change From Baseline in the Percentage of Virtually Plaque-Free Sites (Plaque Index (PI) Scores of 0 or 1) at Week 3
Plaque area was measured based on the Turesky modification of the Quigley-Hein Plaque Index and was scored on six surfaces (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual, and mesiolingual) of all scorable teeth, following disclosing, according to the following scale: 0: No plaque, 1: Separate flecks or discontinuous band of plaque at the gingival (cervical) margin, 2: Thin (up to 1 mm), continuous band of plaque at the gingival margin, 3: Band of plaque wider than 1 mm but less than 1/3 of surface, 4: Plaque covering 1/3 or more, but less than 2/3 of surface, 5: Plaque covering 2/3 or more of surface. The score for each participant was the change from baseline in the percentage of sites with a PI score of 0 or 1 at Week 3.
Measured: Baseline to 3 Weeks
Change From Baseline in the Percentage of Non-Bleeding Sites (Gingival Bleeding Index (BI) Scores of 0) at Week 3
Bleeding was assessed using a periodontal probe with a 0.5 mm diameter tip which was inserted into the gingival crevice, and swept from distal to mesial, around the tooth at an angle of approximately 60 degrees, while in contact with the sulcular epithelium. Each of 4 gingival areas (disto-buccal, midbuccal, mid-lingual, and mesio-lingual) around each tooth was assessed. After approximately 30 seconds, bleeding at each gingival unit was recorded according to the following scale: 0: Absence of bleeding after 30 seconds, 1: Bleeding after 30 seconds, and 2: Immediate bleeding. The score for each participant was the change from baseline in the percentage of sites with a BI score of 0 at Week 3.
Measured: Baseline to 3 Weeks
Change From Baseline in the Percentage of Problem Sites (Modified Gingival Index (MGI) Scores of ≥ 3) at Week 3
Gingivitis was assessed on the buccal and lingual marginal gingivae and interdental papillae of all scorable teeth according to the following scale: 0: Normal (absence of inflammation), 1: Mild inflammation (slight change in color, little change in texture) of any portion of the gingival unit, 2: Mild inflammation of the entire gingival unit, 3: Moderate inflammation (moderate glazing, redness, edema, and/or hypertrophy) of the gingival unit, and 4: Severe inflammation marked redness, edema and/ or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration. The score for each participant was the change from baseline (i.e., Baseline Score minus Week 3 Score) in the percentage of sites with an MGI score ≥3 at Week 3.
Measured: Baseline to 3 Weeks
Change From Baseline in the Percentage of Problem Sites (Plaque Index (PI) Scores of ≥ 3) at Week 3
Plaque area was measured based on the Turesky modification of the Quigley-Hein Plaque Index and was scored on six surfaces (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual, and mesiolingual) of all scorable teeth, following disclosing, according to the following scale: 0: No plaque, 1: Separate flecks or discontinuous band of plaque at the gingival (cervical) margin, 2: Thin (up to 1 mm), continuous band of plaque at the gingival margin, 3: Band of plaque wider than 1 mm but less than 1/3 of surface, 4: Plaque covering 1/3 or more, but less than 2/3 of surface, 5: Plaque covering 2/3 or more of surface. The score for each participant was the change from baseline (i.e., Baseline Score minus Week 3 Score) in the percentage of sites with a PI score ≥3 at Week 3.
Measured: Baseline to 3 Weeks
Change From Baseline in the Percentage of Problem Sites (Plaque Index (PI) Scores of ≥ 2) at Week 3
Plaque area was measured based on the Turesky modification of the Quigley-Hein Plaque Index and was scored on six surfaces (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual, and mesiolingual) of all scorable teeth, following disclosing, according to the following scale: 0: No plaque, 1: Separate flecks or discontinuous band of plaque at the gingival (cervical) margin, 2: Thin (up to 1 mm), continuous band of plaque at the gingival margin, 3: Band of plaque wider than 1 mm but less than 1/3 of surface, 4: Plaque covering 1/3 or more, but less than 2/3 of surface, 5: Plaque covering 2/3 or more of surface. The score for each participant was the change from baseline (i.e., Baseline Score minus Week 3 Score) in the percentage of sites with a PI score ≥2 at Week 3.
Measured: Baseline to 3 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2014 (estimated)
- Study startAug 2014
- Primary completionSep 2014
- Study completionSep 2014
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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Consumer and Personal Products Worldwide
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maher Naji, D.D.S, Principal investigator, All Sum Research Center Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02233998
- Sponsor's protocol ID
- CO-140508133810-OCCT
- Status last verified
- Jul 2015
- First submitted
- 4 Sep 2014
- Last updated
- 21 Aug 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 21 Day Clinical Efficacy of Essential Oil Containing Mouth Rinses: Effect on Reducing Existing Gingivitis and Plaque
- ClinicalTrials.gov ID
- NCT02233998
- Acronym / sponsor ID
- CO-140508133810-OCCT
- Conditions
- Plaque, Gingivitis
- Keywords
- Plaque, Bleeding, Gums, Gingiva, Gingival Inflammation, Gingival Bleeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Johnson & Johnson Consumer and Personal Products WorldwideIndustry (pharma, biotech, devices)
- Study start
- Aug 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 9 Sep 2014 (estimated)
- Results
- Posted 28 Jul 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The reduction of existing plaque and gum inflammation will be evaluated using two marketed mouth rinses along with tooth brushing after 21 days of use compared to a placebo mouth rinse.
165 healthy volunteers will be enrolled in this three week study. Volunteers who qualify to be in this study will have an equal chance of being assigned to one of the three treatment groups. Volunteers will have a total of three visits including 1) Screening/Baseline Day 1 2) Day 11 (after 10 days of use) and 3) Day 22 (after 21 days of use). Volunteers will maintain a diary at home to record each treatment use and will be asked to come to the clinic without brushing or use their product for at least 8 hours, but no more than 18 hours. Examinations for oral hard/soft tissue, gingivitis, bleeding and plaque assessments will be completed at Screening/Baseline and repeated at Clinic Visit 3, which is Day 22.
Detailed description
A sufficient number of generally healthy subjects (approximately 165) that meet the required inclusion/exclusion criteria will be enrolled in this 21 day, examiner-blind, single center, randomized, parallel-group controlled clinical trial to ensure that at least 150 subjects (50 per treatment group) complete this study.
At baseline, the prescreened subjects will present to the clinic site for baseline examinations (oral tissue assessment, gingivitis, bleeding and plaque assessments) having refrained from oral hygiene for at least 8 hours, but no more than 18 hours. After the baseline oral examinations, assessment of other inclusion/exclusion criteria qualifying subjects will be randomly assigned to one of three treatment groups. Immediately following this randomization, subjects will begin use of their assigned test product following the label instructions. If randomized to the control group, subjects will brush twice daily in their usual manner with an ADA accepted fluoride toothpaste and a soft bristled toothbrush followed by rinsing twice daily with a 5% hydroalcohol control rinse (W002194-221P). If randomized to an active treatment group; subjects will brush twice daily in their usual manner, followed by rinsing twice daily with their assigned mouth rinse formulation (19292-116A or 11965-059). Subjects will be instructed to follow label instructions 20ml for 30 seconds twice daily for mouth rinse product. The first product use will be conducted under the 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, brushing and rinsing times. Compliance will be evaluated by weighing residual volumes of returned mouth rinse and by reviewing the subject diary. Subjects will receive an ADA- accepted fluoride-containing dentifrice and a soft bristled toothbrush at their baseline visit.
Subjects may continue to use floss to remove impacted food between the teeth if it is part of their usual oral care regimen during the course of the study; no other oral hygiene procedures will be permitted, including teeth cleaning, whitening or dental procedures except for an emergency treatment. The decision to withdraw a subject due to emergency dental treatment will occur at the discretion of the Investigator.
At baseline and three weeks (±2 days) visits, subject will not have brushed or have used their product for at least 8 hours, but no more than 18 hours.
Oral tissue safety, Modified Gingival Index (MGI), Bleeding Index (BI), and Plaque Index (PI) will be assessed.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mouth Rinse 1 | Active comparator | Other: Mouth Rinse 1After brushing in your normal manner, rinse full strength twice a day with 20 mL for 30 seconds. |
| Mouth Rinse 2 | Active comparator | Other: Mouth Rinse 2After brushing in your normal manner, rinse full strength twice a day with 20 mL for 30 seconds. |
| Mouth Rinse 3 | Placebo comparator | Other: Mouth Rinse 3After brushing in your normal manner, rinse full strength twice a day with 20 mL for 30 seconds. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Able to comprehend and follow the requirements of the study (including availability on scheduled visit dates) based upon research site personnel's assessment;
- 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;
- Males and females 18 years of age or older, in good general and oral health without any known allergy to commercial dental products;
- 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;
- A mean gingival index ≥ 1.95 according to the Modified Gingival Index;
Key exclusion criteria (10 listed)
- 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;
- Dental prophylaxis within 2 weeks prior to Screening visit;
- Antibiotic, anti-inflammatory or anticoagulant therapy during the study or within one month prior to the baseline exam;
- Regular use of chemotherapeutic antiplaque/antigingivitis products such as triclosan, essential oil, cetylpyridinium chloride, or chlorhexidine containing mouth rinses within three weeks prior to baseline;
- 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);
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 1Also: Cool Mint Listerine Antiseptic | Other | Mouth Rinse 1 |
| Mouth Rinse 2Also: Listerine Zero | Other | Mouth Rinse 2 |
| Mouth Rinse 3Also: Placebo | Other | Mouth Rinse 3 |
Primary outcome
Whole Mouth Mean Modified Gingival Index (MGI) at Week 3
Time frame: 3 Weeks
Gingivitis was assessed on the buccal and lingual marginal gingivae and interdental papillae of all scorable teeth according to the following scale: 0: Normal (absence of inflammation), 1: Mild inflammation (slight change in color, little change in texture) of any portion of the gingival unit, 2: Mild inflammation of the entire gingival unit, 3: Moderate inflammation (moderate glazing, redness, edema, and/or hypertrophy) of the gingival unit, and 4: Severe inflammation marked redness, edema and/ or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration. The score for each participant was calculated by averaging their tooth site scores at Week 3.
Whole Mouth Mean Plaque Index (PI) at Week 3
Time frame: 3 Weeks
Plaque area was measured based on the Turesky modification of the Quigley-Hein Plaque Index and was scored on six surfaces (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual, and mesiolingual) of all scorable teeth, following disclosing, according to the following scale: 0: No plaque, 1: Separate flecks or discontinuous band of plaque at the gingival (cervical) margin, 2: Thin (up to 1 mm), continuous band of plaque at the gingival margin, 3: Band of plaque wider than 1 mm but less than 1/3 of surface, 4: Plaque covering 1/3 or more, but less than 2/3 of surface, 5: Plaque covering 2/3 or more of surface. The score for each participant was calculated by averaging their tooth site scores at Week 3.
7 secondary outcomes
Whole Mouth Mean Gingival Bleeding Index (BI) at Week 3
Time frame: 3 Weeks
Change From Baseline in the Percentage of Healthy Sites (Modified Gingival Index (MGI) Scores of 0 or 1) at Week 3
Time frame: Baseline to 3 Weeks
Change From Baseline in the Percentage of Virtually Plaque-Free Sites (Plaque Index (PI) Scores of 0 or 1) at Week 3
Time frame: Baseline to 3 Weeks
Change From Baseline in the Percentage of Non-Bleeding Sites (Gingival Bleeding Index (BI) Scores of 0) at Week 3
Time frame: Baseline to 3 Weeks
Change From Baseline in the Percentage of Problem Sites (Modified Gingival Index (MGI) Scores of ≥ 3) at Week 3
Time frame: Baseline to 3 Weeks
Change From Baseline in the Percentage of Problem Sites (Plaque Index (PI) Scores of ≥ 3) at Week 3
Time frame: Baseline to 3 Weeks
Change From Baseline in the Percentage of Problem Sites (Plaque Index (PI) Scores of ≥ 2) at Week 3
Time frame: Baseline to 3 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Maher Naji, D.D.S principal investigator
All Sum Research Center Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mouth Rinse 1, Mouth Rinse 2 and Mouth Rinse 3 in people with Plaque and Gingivitis, run by Johnson & Johnson Consumer and Personal Products Worldwide 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 21 inclusion and 10 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 21 Aug 2015. 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. 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 28 Jul 2015). 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) at Week 3 (time frame: 3 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 21 Aug 2015.