Trial Outcomes & Findings for Caries Prevention Products & Dentinal Hypersensitivity (NCT NCT02136576)
NCT ID: NCT02136576
Last Updated: 2020-12-10
Results Overview
The primary analysis will be to compare the dentinal hypersensitivity between the 3 groups. Air test: A 1 second blast of air from the air-water syringe was applied to the tooth. Water test: Three drops of ice water were be placed on the tooth. Schiff Score Investigator observed participant reaction to test and scored on following scale: 0-Tooth/Subject does not respond to stimulus. 1. Tooth/Subject responds to stimulus, but does not request discontinuation of stimulus. 2. Tooth/Subject responds to stimulus and requests discontinuation or moves from stimulus. 3. Tooth/Subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus VAS (visual analog scale): The participant reported sensitivity on a scale of 0-10. 0 being no pain and 10 being worst pain imaginable.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
39 participants
Primary outcome timeframe
8 weeks after baseline
Results posted on
2020-12-10
Participant Flow
Unit of analysis: Teeth
Participant milestones
| Measure |
Sensodyne
There are no specific characteristics for inclusion in this group. Enrollment will be determined randomly.
Sensodyne: Subjects will be instructed to brush with Sensodyne twice daily (2 minutes each time in the morning and the evening) during the duration of the study.
|
Crest Cavity Protection & MI Paste Plus
There are no specific characteristics for inclusion in this group. Enrollment will be determined randomly.
Crest Cavity Protection \& MI Paste Plus: Subjects will be instructed to brush twice daily (2 minutes each time in the morning and the evening) using Crest Cavity Protection toothpaste. They will be instructed to apply MI Paste Plus (CPP-ACP with fluoride) twice daily to the study teeth after brushing their teeth. MI Paste Plus will be applied to the study teeth with a finger.
|
Clinpro 5000
There are no specific characteristics for inclusion in this group. Enrollment will be determined randomly.
Clinpro 5000: Subjects will be instructed to brush with Clinpro 5000 twice daily (2 minutes each time in the morning and the evening) during duration of the study.
|
|---|---|---|---|
|
Overall Study
STARTED
|
13 13
|
13 13
|
13 13
|
|
Overall Study
COMPLETED
|
11 11
|
13 13
|
13 13
|
|
Overall Study
NOT COMPLETED
|
2 2
|
0 0
|
0 0
|
Reasons for withdrawal
| Measure |
Sensodyne
There are no specific characteristics for inclusion in this group. Enrollment will be determined randomly.
Sensodyne: Subjects will be instructed to brush with Sensodyne twice daily (2 minutes each time in the morning and the evening) during the duration of the study.
|
Crest Cavity Protection & MI Paste Plus
There are no specific characteristics for inclusion in this group. Enrollment will be determined randomly.
Crest Cavity Protection \& MI Paste Plus: Subjects will be instructed to brush twice daily (2 minutes each time in the morning and the evening) using Crest Cavity Protection toothpaste. They will be instructed to apply MI Paste Plus (CPP-ACP with fluoride) twice daily to the study teeth after brushing their teeth. MI Paste Plus will be applied to the study teeth with a finger.
|
Clinpro 5000
There are no specific characteristics for inclusion in this group. Enrollment will be determined randomly.
Clinpro 5000: Subjects will be instructed to brush with Clinpro 5000 twice daily (2 minutes each time in the morning and the evening) during duration of the study.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
0
|
Baseline Characteristics
Caries Prevention Products & Dentinal Hypersensitivity
Baseline characteristics by cohort
| Measure |
Sensodyne
n=13 Teeth
There are no specific characteristics for inclusion in this group. Enrollment will be determined randomly.
Sensodyne: Subjects will be instructed to brush with Sensodyne twice daily (2 minutes each time in the morning and the evening) during the duration of the study.
|
Crest Cavity Protection & MI Paste Plus
n=13 Teeth
There are no specific characteristics for inclusion in this group. Enrollment will be determined randomly.
Crest Cavity Protection \& MI Paste Plus: Subjects will be instructed to brush twice daily (2 minutes each time in the morning and the evening) using Crest Cavity Protection toothpaste. They will be instructed to apply MI Paste Plus (CPP-ACP with fluoride) twice daily to the study teeth after brushing their teeth. MI Paste Plus will be applied to the study teeth with a finger.
|
Clinpro 5000
n=13 Teeth
There are no specific characteristics for inclusion in this group. Enrollment will be determined randomly.
Clinpro 5000: Subjects will be instructed to brush with Clinpro 5000 twice daily (2 minutes each time in the morning and the evening) during duration of the study.
|
Total
n=39 Teeth
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
37 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Age, Continuous
|
55.08 years
STANDARD_DEVIATION 7.99 • n=99 Participants
|
45.62 years
STANDARD_DEVIATION 15.23 • n=107 Participants
|
45.85 years
STANDARD_DEVIATION 13.64 • n=206 Participants
|
48.85 years
STANDARD_DEVIATION 13.12 • n=7 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
24 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
15 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
15 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
13 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
39 Participants
n=7 Participants
|
|
Baseline Dentinal Hypersensitivity
Air Schiff
|
1 units on a scale
n=5983 Teeth
|
1 units on a scale
n=74 Teeth
|
1 units on a scale
n=180 Teeth
|
1 units on a scale
n=10 Teeth
|
|
Baseline Dentinal Hypersensitivity
Air VAS
|
5 units on a scale
n=5983 Teeth
|
5 units on a scale
n=74 Teeth
|
5 units on a scale
n=180 Teeth
|
5 units on a scale
n=10 Teeth
|
|
Baseline Dentinal Hypersensitivity
Water Schiff
|
1 units on a scale
n=5983 Teeth
|
1 units on a scale
n=74 Teeth
|
1 units on a scale
n=180 Teeth
|
1 units on a scale
n=10 Teeth
|
|
Baseline Dentinal Hypersensitivity
Water VAS
|
6 units on a scale
n=5983 Teeth
|
6 units on a scale
n=74 Teeth
|
6 units on a scale
n=180 Teeth
|
6 units on a scale
n=10 Teeth
|
PRIMARY outcome
Timeframe: 8 weeks after baselineThe primary analysis will be to compare the dentinal hypersensitivity between the 3 groups. Air test: A 1 second blast of air from the air-water syringe was applied to the tooth. Water test: Three drops of ice water were be placed on the tooth. Schiff Score Investigator observed participant reaction to test and scored on following scale: 0-Tooth/Subject does not respond to stimulus. 1. Tooth/Subject responds to stimulus, but does not request discontinuation of stimulus. 2. Tooth/Subject responds to stimulus and requests discontinuation or moves from stimulus. 3. Tooth/Subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus VAS (visual analog scale): The participant reported sensitivity on a scale of 0-10. 0 being no pain and 10 being worst pain imaginable.
Outcome measures
| Measure |
Sensodyne
n=11 Participants
There are no specific characteristics for inclusion in this group. Enrollment will be determined randomly.
Sensodyne: Subjects will be instructed to brush with Sensodyne twice daily (2 minutes each time in the morning and the evening) during the duration of the study.
|
Crest Cavity Protection & MI Paste Plus
n=13 Teeth
There are no specific characteristics for inclusion in this group. Enrollment will be determined randomly.
Crest Cavity Protection \& MI Paste Plus: Subjects will be instructed to brush twice daily (2 minutes each time in the morning and the evening) using Crest Cavity Protection toothpaste. They will be instructed to apply MI Paste Plus (CPP-ACP with fluoride) twice daily to the study teeth after brushing their teeth. MI Paste Plus will be applied to the study teeth with a finger.
|
Clinpro 5000
n=13 Teeth
There are no specific characteristics for inclusion in this group. Enrollment will be determined randomly.
Clinpro 5000: Subjects will be instructed to brush with Clinpro 5000 twice daily (2 minutes each time in the morning and the evening) during duration of the study.
|
|---|---|---|---|
|
Dentinal Hypersensitivity
Air Schiff
|
1 units on a scale
Interval 0.0 to 1.0
|
1 units on a scale
Interval 0.0 to 1.0
|
0 units on a scale
Interval 0.0 to 1.0
|
|
Dentinal Hypersensitivity
Air VAS
|
3 units on a scale
Interval 0.5 to 4.0
|
2 units on a scale
Interval 1.0 to 3.0
|
2 units on a scale
Interval 1.0 to 3.0
|
|
Dentinal Hypersensitivity
Water Schiff
|
1 units on a scale
Interval 0.0 to 1.0
|
1 units on a scale
Interval 0.0 to 1.0
|
1 units on a scale
Interval 0.0 to 1.0
|
|
Dentinal Hypersensitivity
Water VAS
|
4 units on a scale
Interval 2.5 to 5.5
|
2 units on a scale
Interval 1.0 to 3.0
|
2 units on a scale
Interval 1.0 to 5.0
|
Adverse Events
Sensodyne
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Crest Cavity Protection & MI Paste Plus
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Clinpro 5000
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sensodyne
n=13 participants at risk
There are no specific characteristics for inclusion in this group. Enrollment will be determined randomly.
Sensodyne: Subjects will be instructed to brush with Sensodyne twice daily (2 minutes each time in the morning and the evening) during the duration of the study.
|
Crest Cavity Protection & MI Paste Plus
n=13 participants at risk
There are no specific characteristics for inclusion in this group. Enrollment will be determined randomly.
Crest Cavity Protection \& MI Paste Plus: Subjects will be instructed to brush twice daily (2 minutes each time in the morning and the evening) using Crest Cavity Protection toothpaste. They will be instructed to apply MI Paste Plus (CPP-ACP with fluoride) twice daily to the study teeth after brushing their teeth. MI Paste Plus will be applied to the study teeth with a finger.
|
Clinpro 5000
n=13 participants at risk
There are no specific characteristics for inclusion in this group. Enrollment will be determined randomly.
Clinpro 5000: Subjects will be instructed to brush with Clinpro 5000 twice daily (2 minutes each time in the morning and the evening) during duration of the study.
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
0.00%
0/13 • 8 weeks
|
0.00%
0/13 • 8 weeks
|
7.7%
1/13 • 8 weeks
|
|
Infections and infestations
Infection of foot
|
7.7%
1/13 • 8 weeks
|
0.00%
0/13 • 8 weeks
|
0.00%
0/13 • 8 weeks
|
|
Skin and subcutaneous tissue disorders
Skin finding
|
0.00%
0/13 • 8 weeks
|
7.7%
1/13 • 8 weeks
|
0.00%
0/13 • 8 weeks
|
|
Injury, poisoning and procedural complications
Fracture of tooth
|
0.00%
0/13 • 8 weeks
|
7.7%
1/13 • 8 weeks
|
0.00%
0/13 • 8 weeks
|
|
Injury, poisoning and procedural complications
Accidental fall
|
0.00%
0/13 • 8 weeks
|
7.7%
1/13 • 8 weeks
|
0.00%
0/13 • 8 weeks
|
|
Nervous system disorders
Migraine
|
7.7%
1/13 • 8 weeks
|
0.00%
0/13 • 8 weeks
|
0.00%
0/13 • 8 weeks
|
Additional Information
Dr. Britta Magnuson
Tufts University School of Dental Medicine
Phone: 617-636-3878
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place