An interventional study of 3M™ Oral Rinse and Vehicle Control Oral Rinse in Plaque, sponsored by Solventum US LLC. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-01.
Sponsored by Solventum US LLC · Interventional and Prevention
Rinse contains an anti-plaque agent that helps prevent the accumulation of dental plaque associated with gingivitis.
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.
97 studies on the registry are indexed under Plaque, Amyloid; 38 are open to participants now.
This study's enrollment of 200 is above the median of 111 across 70 interventional studies indexed under Plaque, Amyloid.
Browse Plaque, Amyloid studies →Solventum US LLC is the lead sponsor of 64 studies on the registry; 2 are open to participants now.
Of its 18 completed or terminated interventional studies of FDA-regulated products, 16 (89%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Subjects to whom these criteria apply will be entered into the 7-day washout
Subjects must meet the screening inclusion criteria and these additional requirements for enrollment:
Exclusion Criteria:
Subjects to whom these conditions apply will be excluded:
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.
Device: 3M™ 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.
Other: Vehicle Control Oral 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.
Device: PerioShield™ Oral Health Rinse
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.
Other: Water
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).
Also known as: Plaque control device
The Placebo Comparator oral rinse is similar to the Experimental Oral Rinse only it does not contain the active ingredient.
Also known as: Placebo Comparator
PerioShield™ Oral Health Rinse (0.2% delmopinol hydrochloride) is marketed in the US and was purchased for use in this study.
Also known as: Active Comparator
Purified bottled water containing no active ingredients.
Also known as: Sham Comparator
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
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
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
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
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
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
| Milestone | 3M™ Oral Rinse | Vehicle Control Oral Rinse | PerioShield™ Oral Health Rinse | Water |
|---|---|---|---|---|
| Started | 50 | 50 | 50 | 50 |
| Completed | 47 | 48 | 45 | 47 |
| Not completed | 3 | 2 | 5 | 3 |
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.
| score on a scale | 3M™ Oral Rinse | Vehicle Control Oral Rinse | PerioShield™ Oral Health Rinse | Water |
|---|---|---|---|---|
| Plaque Index Score Per Participant at 6 Months | 2.12 ± 0.516 | 2.70 ± 0.453 | 2.23 ± 0.473 | 2.84 ± 0.469 |
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.
| score on a scale | 3M™ Oral Rinse | Vehicle Control Oral Rinse | PerioShield™ Oral Health Rinse | Water |
|---|---|---|---|---|
| Gingivitis Index Score Per Participant at 6 Months | 1.09 ± 0.173 | 1.29 ± 0.144 | 1.11 ± 0.155 | 1.32 ± 0.158 |
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.
| score on a scale | 3M™ Oral Rinse | Vehicle Control Oral Rinse | PerioShield™ Oral Health Rinse | Water |
|---|---|---|---|---|
| Plaque Index Score Per Participant at 3 Months | 2.43 ± 0.501 | 2.79 ± 0.439 | 2.49 ± 0.613 | 2.85 ± 0.476 |
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.
| score on a scale | 3M™ Oral Rinse | Vehicle Control Oral Rinse | PerioShield™ Oral Health Rinse | Water |
|---|---|---|---|---|
| Bleeding Assessment Per Participant at 6 Months | 0.28 ± 0.198 | 0.42 ± 0.197 | 0.28 ± 0.174 | 0.43 ± 0.246 |
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.
| score on a scale | 3M™ Oral Rinse | Vehicle Control Oral Rinse | PerioShield™ Oral Health Rinse | Water |
|---|---|---|---|---|
| Gingivitis Index Per Participant at 3 Months | 1.17 ± 0.191 | 1.27 ± 0.163 | 1.19 ± 0.155 | 1.30 ± 0.164 |
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.
| score on a scale | 3M™ Oral Rinse | Vehicle Control Oral Rinse | PerioShield™ Oral Health Rinse | Water |
|---|---|---|---|---|
| Bleeding Index Per Participant at 3 Months | 0.34 ± 0.229 | 0.40 ± 0.200 | 0.33 ± 0.139 | 0.40 ± 0.247 |
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 3M™ Oral Rinse | 0/50 (0%) | 0/50 (0%) | 32/50 (64%) |
| Vehicle Control Oral Rinse | 0/50 (0%) | 0/50 (0%) | 16/50 (32%) |
| PerioShield™ Oral Health Rinse | 0/50 (0%) | 0/50 (0%) | 43/50 (86%) |
| Water | 0/50 (0%) | 0/50 (0%) | 10/50 (20%) |
| Event | 3M™ Oral Rinse | Vehicle Control Oral Rinse | PerioShield™ Oral Health Rinse | Water |
|---|---|---|---|---|
| Oral hypo-aesthesiaGastrointestinal disorders | 3/50 | 1/50 | 38/50 | 1/50 |
| Oral mucosal exfoliationGastrointestinal disorders | 25/50 | 1/50 | 10/50 | 0/50 |
| DysgeusiaGastrointestinal disorders | 6/50 | 3/50 | 22/50 | 2/50 |
| Dry MouthGastrointestinal disorders | 9/50 | 10/50 | 19/50 | 3/50 |
| Oral discomfortGastrointestinal disorders | 3/50 | 1/50 | 7/50 | 1/50 |
| StomatitisGastrointestinal disorders | 2/50 | 1/50 | 6/50 | 1/50 |
| Dry ThroatGastrointestinal disorders | 0/50 | 1/50 | 3/50 | 0/50 |
| Tooth sensitivityGastrointestinal disorders | 3/50 | 2/50 | 3/50 | 1/50 |
| Oral paraesthesiaGastrointestinal disorders | 0/50 | 0/50 | 3/50 | 0/50 |
| Oral PainGastrointestinal disorders | 2/50 | 2/50 | 0/50 | 0/50 |
| Age, Categorical(Participants) | 3M™ Oral Rinse | Vehicle Control Oral Rinse | PerioShield™ Oral Health Rinse | Water | Total |
|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 47 | 49 | 47 | 46 | 189 |
| >=65 years | 3 | 1 | 3 | 4 | 11 |
| Age, Continuous(years) | 3M™ Oral Rinse | Vehicle Control Oral Rinse | PerioShield™ Oral Health Rinse | Water | Total |
|---|---|---|---|---|---|
| Median | 37 (18 to 67) | 37 (23 to 67) | 37 (20 to 76) | 38 (19 to 72) | 37 (18 to 76) |
| Sex: Female, Male(Participants) | 3M™ Oral Rinse | Vehicle Control Oral Rinse | PerioShield™ Oral Health Rinse | Water | Total |
|---|---|---|---|---|---|
| Female | 19 | 19 | 21 | 21 | 80 |
| Male | 31 | 31 | 29 | 29 | 120 |
| Ethnicity (NIH/OMB)(Participants) | 3M™ Oral Rinse | Vehicle Control Oral Rinse | PerioShield™ Oral Health Rinse | Water | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 15 | 18 | 17 | 19 | 69 |
| Not Hispanic or Latino | 35 | 32 | 33 | 31 | 131 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | 3M™ Oral Rinse | Vehicle Control Oral Rinse | PerioShield™ Oral Health Rinse | Water | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 6 | 6 | 8 | 9 | 29 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 | 0 | 2 |
| Black or African American | 11 | 6 | 5 | 5 | 27 |
| White | 32 | 33 | 35 | 34 | 134 |
| More than one race | 1 | 2 | 1 | 0 | 4 |
| Unknown or Not Reported | 0 | 2 | 0 | 2 | 4 |
| Region of Enrollment(Participants) | 3M™ Oral Rinse | Vehicle Control Oral Rinse | PerioShield™ Oral Health Rinse | Water | Total |
|---|---|---|---|---|---|
| United States | 50 | 50 | 50 | 50 | 200 |
| Plaque Index Score(score on a scale) | 3M™ Oral Rinse | Vehicle Control Oral Rinse | PerioShield™ Oral Health Rinse | Water | Total |
|---|---|---|---|---|---|
| Mean | 2.725 ± 0.4953 | 2.641 ± 0.47 | 2.702 ± 0.4986 | 2.82 ± 0.5597 | 2.722 ± 0.5073 |
| Gingivitis Index Score(score on a scale) | 3M™ Oral Rinse | Vehicle Control Oral Rinse | PerioShield™ Oral Health Rinse | Water | Total |
|---|---|---|---|---|---|
| Mean | 1.277 ± 0.1793 | 1.247 ± 0.1521 | 1.237 ± 0.13 | 1.277 ± 0.2016 | 1.259 ± 0.1676 |
1 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
Ran from Dec 2017 to primary completion in Jan 2019, 13 months.
Results were first posted in Sep 2023, 4 years 8 months after primary completion. A results delay was requested in Jan 2020.
Of 17 interventional studies with no phase under Plaque, Amyloid, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 37. This study's 13 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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