Plaque
Conditions
Keywords
Dental Plaque
Brief summary
Rinse contains an anti-plaque agent that helps prevent the accumulation of dental plaque associated with gingivitis.
Detailed description
This is a prospective, single site, randomized, parallel, blinded clinical trial. Subjects will be randomly assigned to one of four treatment groups identified as Product A, Product B, Product C or Product D. Subjects will be screened for eligibility and entered into a washout period that is at least 7 days, during which time they will be provided with study toothbrush, toothpaste and dental floss. No oral rinses or medication that alters oral tissue health will be used or taken during the washout period. After randomization, the designated rinse will be placed into a non-transparent container so that other subjects and clinical examiners do not see the allocated rinse per the randomization schedule. Examinations for the clinical endpoints (PI, GI and BI) will be conducted at the baseline, 3-month, and 6-month visits. Interim visits will be scheduled to review diary, replenish study supplies, check study compliance, etc. Subjects will be provided Colgate Regular toothpaste, dental floss and a soft toothbrush (replaced at 3 months) for use during the 6-month study period.
Interventions
DEVICE3M™ Oral Rinse
The Investigational Rinse contains a sugar-based surfactant using a proprietary formula. The intended use of the product is to help prevent and reduce plaque accumulation on the teeth and related gum-tissue inflammation (gingivitis).
OTHERVehicle Control Oral Rinse
The Placebo Comparator oral rinse is similar to the Experimental Oral Rinse only it does not contain the active ingredient.
DEVICEPerioShield™ Oral Health Rinse
PerioShield™ Oral Health Rinse (0.2% delmopinol hydrochloride) is marketed in the US and was purchased for use in this study.
OTHERWater
Purified bottled water containing no active ingredients.
Sponsors
3M
Solventum US LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The Principal Investigator and clinical examiners will be blinded to the treatment products. No clinical examiners will see the allocated rinse assigned per the randomization schedule.
Intervention model description
prospective, randomized, blinded, clinical study to evaluate an oral rinse on plaque and gingivitis
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subjects to whom these criteria apply will be entered into the 7-day washout * Able to understand and willing to sign the Informed Consent * In good general health ages 18 and older * Have at least 20 natural teeth, including at least one molar and one premolar in each quadrant but excluding the third molars * Willing to return to the study facility for scheduled study visits and recalls * Agree not to use other oral hygiene products (non-study toothpaste, dental floss, mouth rinse, chewing gum) * Agree not to brush or floss teeth after 10:00 pm the night before and not eat or drink 4 hours before an appointment * Agree to the study instructions and visit schedule, including no eating or drinking for 4 hours before assessment appointments Subjects must meet the screening inclusion criteria and these additional requirements for enrollment: * Completed the washout period (at least 7 days) using only the study toothbrush, dental floss and toothpaste * A qualifying baseline GI of at least 1.0, as determined by the Löe-Silness Gingival Index (GI) * A qualifying baseline Modified Quigley-Hein (Lobene-Soparkar Modification of Turesky's modification) Plaque Index (PI) of at least 1.5 Subjects will be excluded if they do not meet the screening
Exclusion criteria
.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plaque Index Score Per Participant at 6 Months | 6 months | Modified Quigley-Hein Plaque Index 0 = No plaque 1. = Separate flecks of plaque at the cervical margin of the tooth 2. = A thin, continuous band of plaque (up to one mm) at the cervical margin of the tooth. 3. = A band of plaque wider than 1 mm, but covering less than 1/3 of the crown of the tooth. 4. = Plaque covering at least 1/3, but less than 2/3 of the crown of the tooth. 5. = Plaque covering 2/3 or more of the crown of the tooth. Each tooth is scored for supragingival plaque on six surfaces: 1) mesio-facial; 2) mid-facial; 3) disto-facial; 4) mesio-lingual; 5) mid-lingual; and 6) disto-lingual. Third molars and those teeth with cervical restorations or prosthetic crowns will be excluded from the scoring procedure. The PI score of the individual can be obtained by adding the scores of all surfaces and dividing by the number of surfaces examined. |
| Gingivitis Index Score Per Participant at 6 Months | 6 months | Löe-Silness Gingival Index 0 = Absence of inflammation. 1. = Mild inflammation: slight change in color and little change in texture. 2. = Moderate inflammation: moderate glazing, redness, edema, hypertrophy. Tendency to bleed upon probing. 3. = Severe inflammation: marked redness and hypertrophy. Tendency to spontaneous bleeding. The gingival surface surrounding each tooth (all natural teeth) will be scored on six surfaces: 1) mesio-facial; 2) mid-facial; 3) disto-facial; 4) mesio-lingual; 5) mid-lingual; and 6) disto-lingual. Third molars and those teeth with cervical restorations or prosthetic crowns will be excluded from the scoring procedure. The GI score of the individual can be obtained by adding the scores of all surfaces and dividing by the number of surfaces examined. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plaque Index Score Per Participant at 3 Months | 3 months | Modified Quigley-Hein Plaque Index 0 = No plaque 1. = Separate flecks of plaque at the cervical margin of the tooth 2. = A thin, continuous band of plaque (up to one mm) at the cervical margin of the tooth. 3. = A band of plaque wider than 1 mm, but covering less than 1/3 of the crown of the tooth. 4. = Plaque covering at least 1/3, but less than 2/3 of the crown of the tooth. 5. = Plaque covering 2/3 or more of the crown of the tooth. Each tooth is scored for supragingival plaque on six surfaces: 1) mesio-facial; 2) mid-facial; 3) disto-facial; 4) mesio-lingual; 5) mid-lingual; and 6) disto-lingual. Third molars and those teeth with cervical restorations or prosthetic crowns will be excluded from the scoring procedure. The PI score of the individual can be obtained by adding the scores of all surfaces and dividing by the number of surfaces examined. |
| Bleeding Assessment Per Participant at 6 Months | 6 months | Eastman Interdental Bleeding Index 0 = Absence of bleeding. 1 = Presence of bleeding The interdental cleaner is inserted between two teeth from the facial aspect, depressing the interdental tissues 1 to 2 mm. This is repeated four times and the presence or absence of bleeding within 15 seconds is recorded. The absence or presence of bleeding will be recorded for each examined site (between two teeth), and a score will be calculated as the number of bleeding sites out of the number of examined sites for each evaluation on a subject. |
| Gingivitis Index Per Participant at 3 Months | 3 months | Löe-Silness Gingival Index 0 = Absence of inflammation. 1. = Mild inflammation: slight change in color and little change in texture. 2. = Moderate inflammation: moderate glazing, redness, edema, hypertrophy. Tendency to bleed upon probing. 3. = Severe inflammation: marked redness and hypertrophy. Tendency to spontaneous bleeding. The gingival surface surrounding each tooth (all natural teeth) will be scored on six surfaces: 1) mesio-facial; 2) mid-facial; 3) disto-facial; 4) mesio-lingual; 5) mid-lingual; and 6) disto-lingual. Third molars and those teeth with cervical restorations or prosthetic crowns will be excluded from the scoring procedure. The GI score of the individual can be obtained by adding the scores of all surfaces and dividing by the number of surfaces examined. |
| Bleeding Index Per Participant at 3 Months | 3 months | Eastman Interdental Bleeding Index 0 = Absence of bleeding. 1 = Presence of bleeding The interdental cleaner is inserted between two teeth from the facial aspect, depressing the interdental tissues 1 to 2 mm. This is repeated four times and the presence or absence of bleeding within 15 seconds is recorded. The absence or presence of bleeding will be recorded for each examined site (between two teeth), and a score will be calculated as the number of bleeding sites out of the number of examined sites for each evaluation on a subject. |
Countries
United States
Participant flow
Pre-assignment details
Subjects entered a washout phase after meeting screening qualifications. These subjects used the study oral hygiene supplies (toothpaste, toothbrush, and dental floss) for at least 7 days before the baseline qualification visit. Subjects were randomized to enter the study after their baseline qualifications were met.
Participants by arm
| Arm | Count |
|---|---|
| 3M™ Oral Rinse Subjects assigned to the Experimental Oral Rinse ('Plaque control device) will swish a volume of 15 mL of the Experimental Rinse for 30 seconds followed by expectoration, twice a day (morning and evening), after brushing teeth, for the 6-month duration of the study. They will use the dosing cup provided by the study team to ensure that the proper dose of rinse is used. Subjects will be instructed not to eat or drink for 30 minutes after using the rinse and to complete the subject daily diary.
3M™ Oral Rinse: The Investigational Rinse contains a sugar-based surfactant using a proprietary formula. The intended use of the product is to help prevent and reduce plaque accumulation on the teeth and related gum-tissue inflammation (gingivitis). | 50 |
| Vehicle Control Oral Rinse Vehicle control oral rinse (no active ingredient). Subjects assigned to the Placebo Comparator will swish a volume of 15 mL of the Placebo Comparator rinse for 30 seconds followed by expectoration, twice a day (morning and evening), after brushing teeth, for the 6-month duration of the study. They will use the dosing cup provided by the study team to ensure that the proper dose of rinse is used. Subjects will be instructed not to eat or drink for 30 minutes after using the rinse and to complete the subject daily diary.
Vehicle Control Oral Rinse: The Placebo Comparator oral rinse is similar to the Experimental Oral Rinse only it does not contain the active ingredient. | 50 |
| PerioShield™ Oral Health Rinse Active control predicate device oral rinse ('Plaque control agent') Subjects assigned to the Active Comparator will swish a volume of 10 mL of the Active Comparator rinse for 30 seconds followed by expectoration, twice a day (morning and evening), after brushing teeth, for the 6-month duration of the study. They will use the dosing cup provided by the study team to ensure that the proper dose of rinse is used. Subjects will be instructed not to eat or drink for 30 minutes after using the rinse and to complete the subject daily diary.
PerioShield™ Oral Health Rinse: PerioShield™ Oral Health Rinse (0.2% delmopinol hydrochloride) is marketed in the US and was purchased for use in this study. | 50 |
| Water Water sham control oral rinse (not a Plaque control agent) Subjects assigned to the Sham Comparator will swish a volume of 15 mL of the Sham Comparator rinse for 30 seconds followed by expectoration, twice a day (morning and evening), after brushing teeth, for the 6-month duration of the study. They will use the dosing cup provided by the study team to ensure that the proper dose of rinse is used. Subjects will be instructed not to eat or drink for 30 minutes after using the rinse and to complete the subject daily diary.
Water: Purified bottled water containing no active ingredients. | 50 |
| Total | 200 |
Baseline characteristics
| Characteristic | Vehicle Control Oral Rinse | PerioShield™ Oral Health Rinse | 3M™ Oral Rinse | Water | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 3 Participants | 3 Participants | 4 Participants | 11 Participants |
| Age, Categorical Between 18 and 65 years | 49 Participants | 47 Participants | 47 Participants | 46 Participants | 189 Participants |
| Age, Continuous | 37 years | 37 years | 37 years | 38 years | 37 years |
| Bleeding Index Score | 0.413 score on a scale STANDARD_DEVIATION 0.2203 | 0.399 score on a scale STANDARD_DEVIATION 0.196 | 0.452 score on a scale STANDARD_DEVIATION 0.2388 | 0.426 score on a scale STANDARD_DEVIATION 0.2459 | 0.422 score on a scale STANDARD_DEVIATION 0.2253 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 18 Participants | 17 Participants | 15 Participants | 19 Participants | 69 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 32 Participants | 33 Participants | 35 Participants | 31 Participants | 131 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Gingivitis Index Score | 1.247 score on a scale STANDARD_DEVIATION 0.1521 | 1.237 score on a scale STANDARD_DEVIATION 0.13 | 1.277 score on a scale STANDARD_DEVIATION 0.1793 | 1.277 score on a scale STANDARD_DEVIATION 0.2016 | 1.259 score on a scale STANDARD_DEVIATION 0.1676 |
| Plaque Index Score | 2.641 score on a scale STANDARD_DEVIATION 0.47 | 2.702 score on a scale STANDARD_DEVIATION 0.4986 | 2.725 score on a scale STANDARD_DEVIATION 0.4953 | 2.82 score on a scale STANDARD_DEVIATION 0.5597 | 2.722 score on a scale STANDARD_DEVIATION 0.5073 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 8 Participants | 6 Participants | 9 Participants | 29 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 5 Participants | 11 Participants | 5 Participants | 27 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 1 Participants | 1 Participants | 0 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 0 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) White | 33 Participants | 35 Participants | 32 Participants | 34 Participants | 134 Participants |
| Region of Enrollment United States | 50 Participants | 50 Participants | 50 Participants | 50 Participants | 200 Participants |
| Sex: Female, Male Female | 19 Participants | 21 Participants | 19 Participants | 21 Participants | 80 Participants |
| Sex: Female, Male Male | 31 Participants | 29 Participants | 31 Participants | 29 Participants | 120 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 50 | 0 / 50 | 0 / 50 |
| other Total, other adverse events | 32 / 50 | 16 / 50 | 43 / 50 | 10 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 | 0 / 50 | 0 / 50 |
Outcome results
Primary
Gingivitis Index Score Per Participant at 6 Months
Löe-Silness Gingival Index 0 = Absence of inflammation. 1. = Mild inflammation: slight change in color and little change in texture. 2. = Moderate inflammation: moderate glazing, redness, edema, hypertrophy. Tendency to bleed upon probing. 3. = Severe inflammation: marked redness and hypertrophy. Tendency to spontaneous bleeding. The gingival surface surrounding each tooth (all natural teeth) will be scored on six surfaces: 1) mesio-facial; 2) mid-facial; 3) disto-facial; 4) mesio-lingual; 5) mid-lingual; and 6) disto-lingual. Third molars and those teeth with cervical restorations or prosthetic crowns will be excluded from the scoring procedure. The GI score of the individual can be obtained by adding the scores of all surfaces and dividing by the number of surfaces examined.
Time frame: 6 months
Population: Study subjects who completed the study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 3M™ Oral Rinse | Gingivitis Index Score Per Participant at 6 Months | 1.09 score on a scale | Standard Deviation 0.173 |
| Vehicle Control Oral Rinse | Gingivitis Index Score Per Participant at 6 Months | 1.29 score on a scale | Standard Deviation 0.144 |
| PerioShield™ Oral Health Rinse | Gingivitis Index Score Per Participant at 6 Months | 1.11 score on a scale | Standard Deviation 0.155 |
| Water | Gingivitis Index Score Per Participant at 6 Months | 1.32 score on a scale | Standard Deviation 0.158 |
p-value: <0.0001ANCOVA
Primary
Plaque Index Score Per Participant at 6 Months
Modified Quigley-Hein Plaque Index 0 = No plaque 1. = Separate flecks of plaque at the cervical margin of the tooth 2. = A thin, continuous band of plaque (up to one mm) at the cervical margin of the tooth. 3. = A band of plaque wider than 1 mm, but covering less than 1/3 of the crown of the tooth. 4. = Plaque covering at least 1/3, but less than 2/3 of the crown of the tooth. 5. = Plaque covering 2/3 or more of the crown of the tooth. Each tooth is scored for supragingival plaque on six surfaces: 1) mesio-facial; 2) mid-facial; 3) disto-facial; 4) mesio-lingual; 5) mid-lingual; and 6) disto-lingual. Third molars and those teeth with cervical restorations or prosthetic crowns will be excluded from the scoring procedure. The PI score of the individual can be obtained by adding the scores of all surfaces and dividing by the number of surfaces examined.
Time frame: 6 months
Population: study subjects who completed the study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 3M™ Oral Rinse | Plaque Index Score Per Participant at 6 Months | 2.12 score on a scale | Standard Deviation 0.516 |
| Vehicle Control Oral Rinse | Plaque Index Score Per Participant at 6 Months | 2.70 score on a scale | Standard Deviation 0.453 |
| PerioShield™ Oral Health Rinse | Plaque Index Score Per Participant at 6 Months | 2.23 score on a scale | Standard Deviation 0.473 |
| Water | Plaque Index Score Per Participant at 6 Months | 2.84 score on a scale | Standard Deviation 0.469 |
p-value: <0.0001ANCOVA
Secondary
Bleeding Assessment Per Participant at 6 Months
Eastman Interdental Bleeding Index 0 = Absence of bleeding. 1 = Presence of bleeding The interdental cleaner is inserted between two teeth from the facial aspect, depressing the interdental tissues 1 to 2 mm. This is repeated four times and the presence or absence of bleeding within 15 seconds is recorded. The absence or presence of bleeding will be recorded for each examined site (between two teeth), and a score will be calculated as the number of bleeding sites out of the number of examined sites for each evaluation on a subject.
Time frame: 6 months
Population: Study subjects who presented for 6 month follow-up visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 3M™ Oral Rinse | Bleeding Assessment Per Participant at 6 Months | 0.28 score on a scale | Standard Deviation 0.198 |
| Vehicle Control Oral Rinse | Bleeding Assessment Per Participant at 6 Months | 0.42 score on a scale | Standard Deviation 0.197 |
| PerioShield™ Oral Health Rinse | Bleeding Assessment Per Participant at 6 Months | 0.28 score on a scale | Standard Deviation 0.174 |
| Water | Bleeding Assessment Per Participant at 6 Months | 0.43 score on a scale | Standard Deviation 0.246 |
p-value: <0.0001ANCOVA
Secondary
Bleeding Index Per Participant at 3 Months
Eastman Interdental Bleeding Index 0 = Absence of bleeding. 1 = Presence of bleeding The interdental cleaner is inserted between two teeth from the facial aspect, depressing the interdental tissues 1 to 2 mm. This is repeated four times and the presence or absence of bleeding within 15 seconds is recorded. The absence or presence of bleeding will be recorded for each examined site (between two teeth), and a score will be calculated as the number of bleeding sites out of the number of examined sites for each evaluation on a subject.
Time frame: 3 months
Population: study subjects who presented for 3-month follow-up visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 3M™ Oral Rinse | Bleeding Index Per Participant at 3 Months | 0.34 score on a scale | Standard Deviation 0.229 |
| Vehicle Control Oral Rinse | Bleeding Index Per Participant at 3 Months | 0.40 score on a scale | Standard Deviation 0.2 |
| PerioShield™ Oral Health Rinse | Bleeding Index Per Participant at 3 Months | 0.33 score on a scale | Standard Deviation 0.139 |
| Water | Bleeding Index Per Participant at 3 Months | 0.40 score on a scale | Standard Deviation 0.247 |
Secondary
Gingivitis Index Per Participant at 3 Months
Löe-Silness Gingival Index 0 = Absence of inflammation. 1. = Mild inflammation: slight change in color and little change in texture. 2. = Moderate inflammation: moderate glazing, redness, edema, hypertrophy. Tendency to bleed upon probing. 3. = Severe inflammation: marked redness and hypertrophy. Tendency to spontaneous bleeding. The gingival surface surrounding each tooth (all natural teeth) will be scored on six surfaces: 1) mesio-facial; 2) mid-facial; 3) disto-facial; 4) mesio-lingual; 5) mid-lingual; and 6) disto-lingual. Third molars and those teeth with cervical restorations or prosthetic crowns will be excluded from the scoring procedure. The GI score of the individual can be obtained by adding the scores of all surfaces and dividing by the number of surfaces examined.
Time frame: 3 months
Population: Study subjects who presented for 3-month follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 3M™ Oral Rinse | Gingivitis Index Per Participant at 3 Months | 1.17 score on a scale | Standard Deviation 0.191 |
| Vehicle Control Oral Rinse | Gingivitis Index Per Participant at 3 Months | 1.27 score on a scale | Standard Deviation 0.163 |
| PerioShield™ Oral Health Rinse | Gingivitis Index Per Participant at 3 Months | 1.19 score on a scale | Standard Deviation 0.155 |
| Water | Gingivitis Index Per Participant at 3 Months | 1.30 score on a scale | Standard Deviation 0.164 |
p-value: <0.0001ANCOVA
Secondary
Plaque Index Score Per Participant at 3 Months
Modified Quigley-Hein Plaque Index 0 = No plaque 1. = Separate flecks of plaque at the cervical margin of the tooth 2. = A thin, continuous band of plaque (up to one mm) at the cervical margin of the tooth. 3. = A band of plaque wider than 1 mm, but covering less than 1/3 of the crown of the tooth. 4. = Plaque covering at least 1/3, but less than 2/3 of the crown of the tooth. 5. = Plaque covering 2/3 or more of the crown of the tooth. Each tooth is scored for supragingival plaque on six surfaces: 1) mesio-facial; 2) mid-facial; 3) disto-facial; 4) mesio-lingual; 5) mid-lingual; and 6) disto-lingual. Third molars and those teeth with cervical restorations or prosthetic crowns will be excluded from the scoring procedure. The PI score of the individual can be obtained by adding the scores of all surfaces and dividing by the number of surfaces examined.
Time frame: 3 months
Population: Study subjects that presented for 3 month follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 3M™ Oral Rinse | Plaque Index Score Per Participant at 3 Months | 2.43 score on a scale | Standard Deviation 0.501 |
| Vehicle Control Oral Rinse | Plaque Index Score Per Participant at 3 Months | 2.79 score on a scale | Standard Deviation 0.439 |
| PerioShield™ Oral Health Rinse | Plaque Index Score Per Participant at 3 Months | 2.49 score on a scale | Standard Deviation 0.613 |
| Water | Plaque Index Score Per Participant at 3 Months | 2.85 score on a scale | Standard Deviation 0.476 |
p-value: <0.0001ANCOVA