Trial Outcomes & Findings for A Clinical Study to Evaluate Effects of an Oral Rinse on Plaque and Gingivitis (NCT NCT03421145)
NCT ID: NCT03421145
Last Updated: 2024-10-01
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
200 participants
Primary outcome timeframe
6 months
Results posted on
2024-10-01
Participant Flow
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.
Participant milestones
| Measure |
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).
|
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
50
|
50
|
|
Overall Study
COMPLETED
|
47
|
48
|
45
|
47
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
5
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Clinical Study to Evaluate Effects of an Oral Rinse on Plaque and Gingivitis
Baseline characteristics by cohort
| Measure |
3M™ Oral Rinse
n=50 Participants
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).
|
Vehicle Control Oral Rinse
n=50 Participants
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.
|
PerioShield™ Oral Health Rinse
n=50 Participants
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.
|
Water
n=50 Participants
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.
|
Total
n=200 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
47 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
46 Participants
n=4 Participants
|
189 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Age, Continuous
|
37 years
n=5 Participants
|
37 years
n=7 Participants
|
37 years
n=5 Participants
|
38 years
n=4 Participants
|
37 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
80 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
120 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
15 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
69 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
35 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
131 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
32 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
134 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
50 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
200 Participants
n=21 Participants
|
|
Plaque Index Score
|
2.725 score on a scale
STANDARD_DEVIATION 0.4953 • n=5 Participants
|
2.641 score on a scale
STANDARD_DEVIATION 0.47 • n=7 Participants
|
2.702 score on a scale
STANDARD_DEVIATION 0.4986 • n=5 Participants
|
2.82 score on a scale
STANDARD_DEVIATION 0.5597 • n=4 Participants
|
2.722 score on a scale
STANDARD_DEVIATION 0.5073 • n=21 Participants
|
|
Gingivitis Index Score
|
1.277 score on a scale
STANDARD_DEVIATION 0.1793 • n=5 Participants
|
1.247 score on a scale
STANDARD_DEVIATION 0.1521 • n=7 Participants
|
1.237 score on a scale
STANDARD_DEVIATION 0.13 • n=5 Participants
|
1.277 score on a scale
STANDARD_DEVIATION 0.2016 • n=4 Participants
|
1.259 score on a scale
STANDARD_DEVIATION 0.1676 • n=21 Participants
|
|
Bleeding Index Score
|
0.452 score on a scale
STANDARD_DEVIATION 0.2388 • n=5 Participants
|
0.413 score on a scale
STANDARD_DEVIATION 0.2203 • n=7 Participants
|
0.399 score on a scale
STANDARD_DEVIATION 0.196 • n=5 Participants
|
0.426 score on a scale
STANDARD_DEVIATION 0.2459 • n=4 Participants
|
0.422 score on a scale
STANDARD_DEVIATION 0.2253 • n=21 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: study subjects who completed the study
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.
Outcome measures
| Measure |
3M™ Oral Rinse
n=47 Participants
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).
|
Vehicle Control Oral Rinse
n=48 Participants
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.
|
PerioShield™ Oral Health Rinse
n=45 Participants
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.
|
Water
n=47 Participants
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.
|
|---|---|---|---|---|
|
Plaque Index Score Per Participant at 6 Months
|
2.12 score on a scale
Standard Deviation 0.516
|
2.70 score on a scale
Standard Deviation 0.453
|
2.23 score on a scale
Standard Deviation 0.473
|
2.84 score on a scale
Standard Deviation 0.469
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Study subjects who completed the study
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.
Outcome measures
| Measure |
3M™ Oral Rinse
n=47 Participants
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).
|
Vehicle Control Oral Rinse
n=48 Participants
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.
|
PerioShield™ Oral Health Rinse
n=45 Participants
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.
|
Water
n=47 Participants
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.
|
|---|---|---|---|---|
|
Gingivitis Index Score Per Participant at 6 Months
|
1.09 score on a scale
Standard Deviation 0.173
|
1.29 score on a scale
Standard Deviation 0.144
|
1.11 score on a scale
Standard Deviation 0.155
|
1.32 score on a scale
Standard Deviation 0.158
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Study subjects that presented for 3 month follow-up
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.
Outcome measures
| Measure |
3M™ Oral Rinse
n=48 Participants
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).
|
Vehicle Control Oral Rinse
n=48 Participants
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.
|
PerioShield™ Oral Health Rinse
n=46 Participants
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.
|
Water
n=48 Participants
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.
|
|---|---|---|---|---|
|
Plaque Index Score Per Participant at 3 Months
|
2.43 score on a scale
Standard Deviation 0.501
|
2.79 score on a scale
Standard Deviation 0.439
|
2.49 score on a scale
Standard Deviation 0.613
|
2.85 score on a scale
Standard Deviation 0.476
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Study subjects who presented for 6 month follow-up visit
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.
Outcome measures
| Measure |
3M™ Oral Rinse
n=47 Participants
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).
|
Vehicle Control Oral Rinse
n=48 Participants
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.
|
PerioShield™ Oral Health Rinse
n=45 Participants
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.
|
Water
n=47 Participants
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.
|
|---|---|---|---|---|
|
Bleeding Assessment Per Participant at 6 Months
|
0.28 score on a scale
Standard Deviation 0.198
|
0.42 score on a scale
Standard Deviation 0.197
|
0.28 score on a scale
Standard Deviation 0.174
|
0.43 score on a scale
Standard Deviation 0.246
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Study subjects who presented for 3-month follow-up
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.
Outcome measures
| Measure |
3M™ Oral Rinse
n=48 Participants
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).
|
Vehicle Control Oral Rinse
n=48 Participants
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.
|
PerioShield™ Oral Health Rinse
n=46 Participants
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.
|
Water
n=48 Participants
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.
|
|---|---|---|---|---|
|
Gingivitis Index Per Participant at 3 Months
|
1.17 score on a scale
Standard Deviation 0.191
|
1.27 score on a scale
Standard Deviation 0.163
|
1.19 score on a scale
Standard Deviation 0.155
|
1.30 score on a scale
Standard Deviation 0.164
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: study subjects who presented for 3-month follow-up visit
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.
Outcome measures
| Measure |
3M™ Oral Rinse
n=48 Participants
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).
|
Vehicle Control Oral Rinse
n=48 Participants
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.
|
PerioShield™ Oral Health Rinse
n=46 Participants
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.
|
Water
n=48 Participants
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.
|
|---|---|---|---|---|
|
Bleeding Index Per Participant at 3 Months
|
0.34 score on a scale
Standard Deviation 0.229
|
0.40 score on a scale
Standard Deviation 0.200
|
0.33 score on a scale
Standard Deviation 0.139
|
0.40 score on a scale
Standard Deviation 0.247
|
Adverse Events
3M™ Oral Rinse
Serious events: 0 serious events
Other events: 32 other events
Deaths: 0 deaths
Vehicle Control Oral Rinse
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
PerioShield™ Oral Health Rinse
Serious events: 0 serious events
Other events: 43 other events
Deaths: 0 deaths
Water
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
3M™ Oral Rinse
n=50 participants at risk
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).
|
Vehicle Control Oral Rinse
n=50 participants at risk
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.
|
PerioShield™ Oral Health Rinse
n=50 participants at risk
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.
|
Water
n=50 participants at risk
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.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Dry Mouth
|
18.0%
9/50 • Number of events 9 • 6 months
|
20.0%
10/50 • Number of events 10 • 6 months
|
38.0%
19/50 • Number of events 19 • 6 months
|
6.0%
3/50 • Number of events 3 • 6 months
|
|
Gastrointestinal disorders
Dry Throat
|
0.00%
0/50 • 6 months
|
2.0%
1/50 • Number of events 1 • 6 months
|
6.0%
3/50 • Number of events 3 • 6 months
|
0.00%
0/50 • 6 months
|
|
Gastrointestinal disorders
Dysgeusia
|
12.0%
6/50 • Number of events 6 • 6 months
|
6.0%
3/50 • Number of events 3 • 6 months
|
44.0%
22/50 • Number of events 22 • 6 months
|
4.0%
2/50 • Number of events 2 • 6 months
|
|
Gastrointestinal disorders
Oral discomfort
|
6.0%
3/50 • Number of events 3 • 6 months
|
2.0%
1/50 • Number of events 1 • 6 months
|
14.0%
7/50 • Number of events 7 • 6 months
|
2.0%
1/50 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Oral hypo-aesthesia
|
6.0%
3/50 • Number of events 3 • 6 months
|
2.0%
1/50 • Number of events 1 • 6 months
|
76.0%
38/50 • Number of events 38 • 6 months
|
2.0%
1/50 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Oral mucosal exfoliation
|
50.0%
25/50 • Number of events 25 • 6 months
|
2.0%
1/50 • Number of events 1 • 6 months
|
20.0%
10/50 • Number of events 10 • 6 months
|
0.00%
0/50 • 6 months
|
|
Gastrointestinal disorders
Tooth sensitivity
|
6.0%
3/50 • Number of events 3 • 6 months
|
4.0%
2/50 • Number of events 2 • 6 months
|
6.0%
3/50 • Number of events 3 • 6 months
|
2.0%
1/50 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Stomatitis
|
4.0%
2/50 • Number of events 2 • 6 months
|
2.0%
1/50 • Number of events 1 • 6 months
|
12.0%
6/50 • Number of events 6 • 6 months
|
2.0%
1/50 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Chapped Lips
|
0.00%
0/50 • 6 months
|
0.00%
0/50 • 6 months
|
2.0%
1/50 • Number of events 1 • 6 months
|
2.0%
1/50 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Mouth hemorrhage
|
0.00%
0/50 • 6 months
|
0.00%
0/50 • 6 months
|
2.0%
1/50 • Number of events 1 • 6 months
|
0.00%
0/50 • 6 months
|
|
Gastrointestinal disorders
Mouth swelling
|
0.00%
0/50 • 6 months
|
0.00%
0/50 • 6 months
|
2.0%
1/50 • Number of events 1 • 6 months
|
2.0%
1/50 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Oral Pain
|
4.0%
2/50 • Number of events 2 • 6 months
|
4.0%
2/50 • Number of events 2 • 6 months
|
0.00%
0/50 • 6 months
|
0.00%
0/50 • 6 months
|
|
Gastrointestinal disorders
Oral paraesthesia
|
0.00%
0/50 • 6 months
|
0.00%
0/50 • 6 months
|
6.0%
3/50 • Number of events 3 • 6 months
|
0.00%
0/50 • 6 months
|
|
Gastrointestinal disorders
Root canal infection
|
2.0%
1/50 • Number of events 1 • 6 months
|
0.00%
0/50 • 6 months
|
0.00%
0/50 • 6 months
|
0.00%
0/50 • 6 months
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
2.0%
1/50 • Number of events 1 • 6 months
|
2.0%
1/50 • Number of events 1 • 6 months
|
0.00%
0/50 • 6 months
|
0.00%
0/50 • 6 months
|
|
Infections and infestations
Urinary tract infection
|
2.0%
1/50 • Number of events 1 • 6 months
|
0.00%
0/50 • 6 months
|
2.0%
1/50 • Number of events 1 • 6 months
|
0.00%
0/50 • 6 months
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/50 • 6 months
|
2.0%
1/50 • Number of events 1 • 6 months
|
0.00%
0/50 • 6 months
|
0.00%
0/50 • 6 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/50 • 6 months
|
2.0%
1/50 • Number of events 1 • 6 months
|
0.00%
0/50 • 6 months
|
0.00%
0/50 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.0%
1/50 • Number of events 1 • 6 months
|
0.00%
0/50 • 6 months
|
0.00%
0/50 • 6 months
|
0.00%
0/50 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place