Trial Outcomes & Findings for Clinical Efficacy Of BioMin F, Colgate Sensitive Pro-Relief And Sensodyne Rapid Action Dentifrices In DH (NCT NCT04249336)
NCT ID: NCT04249336
Last Updated: 2021-05-11
Results Overview
SCHIFF cold air sensitivity scale was used to measure the intensity of pain due to dentin hypersensitivity using air blast stimulus. Patients' response of pain was assessed by the doctor according to following score range from; "0"(no response of pain), "1" (pain response but no request of discontinuity of stimulus), "2"(pain response with request of discontinuity of stimulus), "3"(Immediate pain response for discontinuity of stimulus). Percent change in mean scores = ( one minute score-Baseline score) / Baseline score
COMPLETED
PHASE3
140 participants
(Base line to 1 minute) (Base line to 5 minutes)(Base line to day 3)(Base line to week 4)
2021-05-11
Participant Flow
Participants were recruited and enrolled based on self reported sensitivity in teeth followed by clinical diagnosis of dentin hypersensitivity using Air blast stimulus response on SCHIFF Air Blast Sensitivity Scale at Department of Periodontology, Dr. Ishrat-ul-Ibad Khan Institute of Oral Health Sciences, DUHS, Karachi between September 2019 to December 2020. The first Participant was enrolled in September 27, 2019 and last participant was enrolled in October 2020.
Of 380 assessed participants of self reported sensitivity in teeth, 140 met inclusion criteria and were randomized to treatment.
Participant milestones
| Measure |
Colgate Sensitive Pro Relief
Participants received Colgate Sensitive Pro relief Trademark Dentifrices and instructed to brush their teeth with a full strip of dentifrices on a dry toothbrush for 1 minute twice daily for 4 weeks.
Colgate Sensitive Pro relief Trade Mark Dentifrices : 8% Arginine and calcium carbonate, tubular occluding formulation
|
BioMin F
Participants received BioMin F Dentifrices and instructed to brush their teeth with a full strip of dentifrices on a dry toothbrush for 1 minute twice daily for 4 weeks.
BioMin F Dentifrices : Fluoro-Calcium-Phospho-Silicate, Bio-Active glass based tubular occluding formulation
|
Sensodyne Rapid Action
Participants received Sensodyne Rapid Action dentifrices and instructed to brush their teeth with a full strip of dentifrices on a dry toothbrush for 1 minute twice daily for 4 weeks.
Sensodyne Rapid Action Trademark Dentifrices : 8% Strontium Acetate with tubular occluding formulation.
|
Colgate Total
Participants received Colgate Total dentifrices and instructed to brush their teeth with a full strip of dentifrices on a dry toothbrush for 1 minute twice daily for 4 weeks.
Colgate Total Trademark Dentifrices : Sodium Fluoride with no claim of relieving Dentin Hypersensitivity
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
35
|
35
|
35
|
35
|
|
Overall Study
Per Protocol Population Day 3
|
32
|
32
|
32
|
32
|
|
Overall Study
Per Protocol Population Week 4
|
33
|
35
|
33
|
34
|
|
Overall Study
COMPLETED
|
32
|
32
|
32
|
32
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
3
|
3
|
Reasons for withdrawal
| Measure |
Colgate Sensitive Pro Relief
Participants received Colgate Sensitive Pro relief Trademark Dentifrices and instructed to brush their teeth with a full strip of dentifrices on a dry toothbrush for 1 minute twice daily for 4 weeks.
Colgate Sensitive Pro relief Trade Mark Dentifrices : 8% Arginine and calcium carbonate, tubular occluding formulation
|
BioMin F
Participants received BioMin F Dentifrices and instructed to brush their teeth with a full strip of dentifrices on a dry toothbrush for 1 minute twice daily for 4 weeks.
BioMin F Dentifrices : Fluoro-Calcium-Phospho-Silicate, Bio-Active glass based tubular occluding formulation
|
Sensodyne Rapid Action
Participants received Sensodyne Rapid Action dentifrices and instructed to brush their teeth with a full strip of dentifrices on a dry toothbrush for 1 minute twice daily for 4 weeks.
Sensodyne Rapid Action Trademark Dentifrices : 8% Strontium Acetate with tubular occluding formulation.
|
Colgate Total
Participants received Colgate Total dentifrices and instructed to brush their teeth with a full strip of dentifrices on a dry toothbrush for 1 minute twice daily for 4 weeks.
Colgate Total Trademark Dentifrices : Sodium Fluoride with no claim of relieving Dentin Hypersensitivity
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
3
|
3
|
3
|
Baseline Characteristics
Total lost to follow up was 12 out of 140 enrolled participants. Lost to follow up per group was 3 out of 35. Statistical analysis was performed for 32 participants per group.
Baseline characteristics by cohort
| Measure |
BioMin F Dentifrices
n=32 Participants
Participants were instructed to dose a dry toothbrush with a full strip of dentifrices and to brush teeth for 1 minute twice daily.
Fluoro-Calcium-Phospho-Silicate based dentifrices: Bio-Active glass based formulation
|
Colgate Sensitive Pro Relief Trademark Dentifrices
n=32 Participants
Participants were instructed to dose a dry toothbrush with a full strip of dentifrices and to brush teeth for 1 minute twice daily.
8% Arginine based dentifrices: Tubular occluding formulation
|
Sensodyne Rapid Action Trademark Dentifrices
n=32 Participants
Participants were instructed to dose a dry toothbrush with a full strip of dentifrices and to brush teeth for 1 minute twice daily.
8% Strontium Acetate: Tubular occluding formulation
|
Colgate Total Trademark
n=32 Participants
Participants were instructed to dose a dry toothbrush with a full strip of dentifrices and to brush teeth for 1 minute twice daily.
Sodium Fluoride: No claim of relieving Dentin Hypersensitivity
|
Total
n=128 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
33.23 years
STANDARD_DEVIATION 8.77 • n=32 Participants
|
34.40 years
STANDARD_DEVIATION 8.43 • n=32 Participants
|
35.63 years
STANDARD_DEVIATION 9.55 • n=32 Participants
|
34.14 years
STANDARD_DEVIATION 9.08 • n=32 Participants
|
34.10 years
STANDARD_DEVIATION 8.93 • n=128 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=32 Participants
|
21 Participants
n=32 Participants
|
17 Participants
n=32 Participants
|
20 Participants
n=32 Participants
|
80 Participants
n=128 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=32 Participants
|
11 Participants
n=32 Participants
|
15 Participants
n=32 Participants
|
12 Participants
n=32 Participants
|
48 Participants
n=128 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=32 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=128 Participants
|
|
Race (NIH/OMB)
Asian
|
32 Participants
n=32 Participants
|
32 Participants
n=32 Participants
|
32 Participants
n=32 Participants
|
32 Participants
n=32 Participants
|
128 Participants
n=128 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=32 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=128 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=32 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=128 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=32 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=128 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=32 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=128 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=32 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=128 Participants
|
|
Summary of the baseline SCHIFF cold air sensitivity scale for air blast stimulus response
|
2.46 scores on a scale
STANDARD_DEVIATION 0.50 • n=32 Participants • Total lost to follow up was 12 out of 140 enrolled participants. Lost to follow up per group was 3 out of 35. Statistical analysis was performed for 32 participants per group.
|
2.46 scores on a scale
STANDARD_DEVIATION 0.50 • n=32 Participants • Total lost to follow up was 12 out of 140 enrolled participants. Lost to follow up per group was 3 out of 35. Statistical analysis was performed for 32 participants per group.
|
2.46 scores on a scale
STANDARD_DEVIATION 0.50 • n=32 Participants • Total lost to follow up was 12 out of 140 enrolled participants. Lost to follow up per group was 3 out of 35. Statistical analysis was performed for 32 participants per group.
|
2.46 scores on a scale
STANDARD_DEVIATION 0.50 • n=32 Participants • Total lost to follow up was 12 out of 140 enrolled participants. Lost to follow up per group was 3 out of 35. Statistical analysis was performed for 32 participants per group.
|
2.46 scores on a scale
STANDARD_DEVIATION 0.50 • n=128 Participants • Total lost to follow up was 12 out of 140 enrolled participants. Lost to follow up per group was 3 out of 35. Statistical analysis was performed for 32 participants per group.
|
|
Summary of the baseline Visual Analog scale for Mechanical and Water jet stimulus response
Mechanical hypersensitivity baseline score
|
6.75 scores on a scale
STANDARD_DEVIATION 0.91 • n=20 Participants • Out of 35 participants per group, 20 participants responded on Visual Analogue Scale for DH in 4-week trial.
|
6.70 scores on a scale
STANDARD_DEVIATION 1.03 • n=20 Participants • Out of 35 participants per group, 20 participants responded on Visual Analogue Scale for DH in 4-week trial.
|
6.70 scores on a scale
STANDARD_DEVIATION 1.17 • n=20 Participants • Out of 35 participants per group, 20 participants responded on Visual Analogue Scale for DH in 4-week trial.
|
6.70 scores on a scale
STANDARD_DEVIATION 1.03 • n=20 Participants • Out of 35 participants per group, 20 participants responded on Visual Analogue Scale for DH in 4-week trial.
|
6.71 scores on a scale
STANDARD_DEVIATION 1.02 • n=80 Participants • Out of 35 participants per group, 20 participants responded on Visual Analogue Scale for DH in 4-week trial.
|
|
Summary of the baseline Visual Analog scale for Mechanical and Water jet stimulus response
Water Jet hypersensitivity baseline score
|
6.70 scores on a scale
STANDARD_DEVIATION 0.80 • n=20 Participants • Out of 35 participants per group, 20 participants responded on Visual Analogue Scale for DH in 4-week trial.
|
6.18 scores on a scale
STANDARD_DEVIATION 2.23 • n=20 Participants • Out of 35 participants per group, 20 participants responded on Visual Analogue Scale for DH in 4-week trial.
|
6.75 scores on a scale
STANDARD_DEVIATION 0.91 • n=20 Participants • Out of 35 participants per group, 20 participants responded on Visual Analogue Scale for DH in 4-week trial.
|
6.48 scores on a scale
STANDARD_DEVIATION 1.69 • n=20 Participants • Out of 35 participants per group, 20 participants responded on Visual Analogue Scale for DH in 4-week trial.
|
6.52 scores on a scale
STANDARD_DEVIATION 1.54 • n=80 Participants • Out of 35 participants per group, 20 participants responded on Visual Analogue Scale for DH in 4-week trial.
|
PRIMARY outcome
Timeframe: (Base line to 1 minute) (Base line to 5 minutes)(Base line to day 3)(Base line to week 4)Population: 35 individuals per treatment group were recruited and enrolled in the study after clinical diagnosis of dentin hypersensitivity using air blast stimulus and SCHIFF cold air sensitivity scale. These participants were tested again for dentin hypersensitivity using mechanical stimulus and Visual Analogue Scale. After lost to follow up, statistical analysis was performed for 32 participants per group with baseline SCHIFF scale score of ≥2.
SCHIFF cold air sensitivity scale was used to measure the intensity of pain due to dentin hypersensitivity using air blast stimulus. Patients' response of pain was assessed by the doctor according to following score range from; "0"(no response of pain), "1" (pain response but no request of discontinuity of stimulus), "2"(pain response with request of discontinuity of stimulus), "3"(Immediate pain response for discontinuity of stimulus). Percent change in mean scores = ( one minute score-Baseline score) / Baseline score
Outcome measures
| Measure |
BioMin F
n=32 Participants
Participants received BioMin F Dentifrices and instructed to brush their teeth with a full strip of dentifrices on a dry toothbrush for 1 minute twice daily for 4 weeks.
BioMin F Dentifrices : Fluoro-Calcium-Phospho-Silicate, Bio-Active glass based tubular occluding formulation
|
Colgate Sensitive Pro Relief
n=32 Participants
Participants received Colgate Sensitive Pro relief Trademark Dentifrices and instructed to brush their teeth with a full strip of dentifrices on a dry toothbrush for 1 minute twice daily for 4 weeks.
Colgate Sensitive Pro relief Trade Mark Dentifrices : 8% Arginine and calcium carbonate, tubular occluding formulation
|
Sensodyne Rapid Action
n=32 Participants
Participants received Sensodyne Rapid Action dentifrices and instructed to brush their teeth with a full strip of dentifrices on a dry toothbrush for 1 minute twice daily for 4 weeks.
Sensodyne Rapid Action Trademark Dentifrices : 8% Strontium Acetate with tubular occluding formulation.
|
Colgate Total
n=32 Participants
Participants received Colgate Total dentifrices and instructed to brush their teeth with a full strip of dentifrices on a dry toothbrush for 1 minute twice daily for 4 weeks.
Colgate Total Trademark Dentifrices : Sodium Fluoride with no claim of relieving Dentin Hypersensitivity
|
|---|---|---|---|---|
|
Percent Change in Mean Score of Pain Response From Baseline on Schiff Cold Air Sensitivity Scale Using Air Blast Stimulus
1- minute
|
18 percentage of change in mean scores
Standard Deviation 21
|
45 percentage of change in mean scores
Standard Deviation 24
|
37 percentage of change in mean scores
Standard Deviation 27
|
15 percentage of change in mean scores
Standard Deviation 22
|
|
Percent Change in Mean Score of Pain Response From Baseline on Schiff Cold Air Sensitivity Scale Using Air Blast Stimulus
5-minutes
|
27 percentage of change in mean scores
Standard Deviation 22
|
56 percentage of change in mean scores
Standard Deviation 25
|
51 percentage of change in mean scores
Standard Deviation 28
|
19 percentage of change in mean scores
Standard Deviation 21
|
|
Percent Change in Mean Score of Pain Response From Baseline on Schiff Cold Air Sensitivity Scale Using Air Blast Stimulus
Day-3
|
22 percentage of change in mean scores
Standard Deviation 22
|
24 percentage of change in mean scores
Standard Deviation 21
|
25 percentage of change in mean scores
Standard Deviation 21
|
10 percentage of change in mean scores
Standard Deviation 18
|
|
Percent Change in Mean Score of Pain Response From Baseline on Schiff Cold Air Sensitivity Scale Using Air Blast Stimulus
Week-4
|
58 percentage of change in mean scores
Standard Deviation 26
|
55 percentage of change in mean scores
Standard Deviation 24
|
45 percentage of change in mean scores
Standard Deviation 25
|
22 percentage of change in mean scores
Standard Deviation 24
|
SECONDARY outcome
Timeframe: (Base line to 1 minute) (Base line to 5 minutes)(Base line to day 3)(Base line to week 4)Population: 35 individuals per treatment group were recruited and enrolled in the study after clinical diagnosis of dentin hypersensitivity using air blast stimulus and SCHIFF cold air sensitivity scale. These participants were tested again for dentin hypersensitivity using mechanical stimulus and Visual Analogue Scale. Statistical analysis was performed for 20 participants out of 32 per group with visual Analogue Scale score of ≥4.
Visual Analogue Scale was used to measure the intensity of pain due to dentin hypersensitivity using mechanical stimulus. Patient's response of pain was assessed on vertical line of 0 to 10cm by asking him to move finger on the line and stop it where he felt pain. Score range from; 0 (no pain at 0cm), 1(mild pain at 1cm), 2(mild pain at 2cm), 3(mild pain at 3cm), 4(moderate pain at 4cm), 5(moderate pain at 5cm), 6(moderate pain at 6cm), 7(severe pain at 7cm), 8(severe pain at 8cm), 9(severe pain at 9cm),10(worst imaginable pain at 10cm). Percent change in mean scores = (one minute score-Baseline score) / Baseline score
Outcome measures
| Measure |
BioMin F
n=20 Participants
Participants received BioMin F Dentifrices and instructed to brush their teeth with a full strip of dentifrices on a dry toothbrush for 1 minute twice daily for 4 weeks.
BioMin F Dentifrices : Fluoro-Calcium-Phospho-Silicate, Bio-Active glass based tubular occluding formulation
|
Colgate Sensitive Pro Relief
n=20 Participants
Participants received Colgate Sensitive Pro relief Trademark Dentifrices and instructed to brush their teeth with a full strip of dentifrices on a dry toothbrush for 1 minute twice daily for 4 weeks.
Colgate Sensitive Pro relief Trade Mark Dentifrices : 8% Arginine and calcium carbonate, tubular occluding formulation
|
Sensodyne Rapid Action
n=20 Participants
Participants received Sensodyne Rapid Action dentifrices and instructed to brush their teeth with a full strip of dentifrices on a dry toothbrush for 1 minute twice daily for 4 weeks.
Sensodyne Rapid Action Trademark Dentifrices : 8% Strontium Acetate with tubular occluding formulation.
|
Colgate Total
n=20 Participants
Participants received Colgate Total dentifrices and instructed to brush their teeth with a full strip of dentifrices on a dry toothbrush for 1 minute twice daily for 4 weeks.
Colgate Total Trademark Dentifrices : Sodium Fluoride with no claim of relieving Dentin Hypersensitivity
|
|---|---|---|---|---|
|
Percent Change in Mean Scores of Pain Response From Baseline on Visual Analog Scale Using Mechanical Stimulus
1-minute
|
25 percentage of change in mean scores
Standard Deviation 22
|
56 percentage of change in mean scores
Standard Deviation 27
|
46 percentage of change in mean scores
Standard Deviation 26
|
16 percentage of change in mean scores
Standard Deviation 13
|
|
Percent Change in Mean Scores of Pain Response From Baseline on Visual Analog Scale Using Mechanical Stimulus
5-minutes
|
27 percentage of change in mean scores
Standard Deviation 23
|
61 percentage of change in mean scores
Standard Deviation 26
|
51 percentage of change in mean scores
Standard Deviation 27
|
20 percentage of change in mean scores
Standard Deviation 13
|
|
Percent Change in Mean Scores of Pain Response From Baseline on Visual Analog Scale Using Mechanical Stimulus
Day-3
|
28 percentage of change in mean scores
Standard Deviation 15
|
38 percentage of change in mean scores
Standard Deviation 20
|
32 percentage of change in mean scores
Standard Deviation 20
|
18 percentage of change in mean scores
Standard Deviation 12
|
|
Percent Change in Mean Scores of Pain Response From Baseline on Visual Analog Scale Using Mechanical Stimulus
Week-4
|
59 percentage of change in mean scores
Standard Deviation 27
|
66 percentage of change in mean scores
Standard Deviation 27
|
57 percentage of change in mean scores
Standard Deviation 27
|
27 percentage of change in mean scores
Standard Deviation 16
|
SECONDARY outcome
Timeframe: (Base line to 1 minute) (Base line to 5 minutes)(Base line to day 3)(Base line to week 4)Population: 35 individuals per treatment group were recruited and enrolled in the study after clinical diagnosis of dentin hypersensitivity using air blast stimulus and SCHIFF cold air sensitivity scale. These participants were tested again for dentin hypersensitivity using water jet stimulus and Visual Analogue Scale. Statistical analysis was performed for 20 participants out of 32 with Visual Analogue Scale score of ≥4.
Visual Analogue Scale was used to measure the intensity of pain due to dentin hypersensitivity using Water Jet Stimulus. Patient's response of pain was assessed on vertical line of 0 to 10cm by asking him to move finger on the line and stop it where he felt pain. Score range from; 0 (no pain at 0cm), 1(mild pain at 1cm), 2(mild pain at 2cm), 3(mild pain at 3cm), 4(moderate pain at 4cm), 5(moderate pain at 5cm), 6(moderate pain at 6cm), 7(severe pain at 7cm), 8(severe pain at 8cm), 9(severe pain at 9cm),10(worst imaginable pain at 10cm). Percent change in mean scores = (one minute score-Baseline score) / Baseline score
Outcome measures
| Measure |
BioMin F
n=20 Participants
Participants received BioMin F Dentifrices and instructed to brush their teeth with a full strip of dentifrices on a dry toothbrush for 1 minute twice daily for 4 weeks.
BioMin F Dentifrices : Fluoro-Calcium-Phospho-Silicate, Bio-Active glass based tubular occluding formulation
|
Colgate Sensitive Pro Relief
n=20 Participants
Participants received Colgate Sensitive Pro relief Trademark Dentifrices and instructed to brush their teeth with a full strip of dentifrices on a dry toothbrush for 1 minute twice daily for 4 weeks.
Colgate Sensitive Pro relief Trade Mark Dentifrices : 8% Arginine and calcium carbonate, tubular occluding formulation
|
Sensodyne Rapid Action
n=20 Participants
Participants received Sensodyne Rapid Action dentifrices and instructed to brush their teeth with a full strip of dentifrices on a dry toothbrush for 1 minute twice daily for 4 weeks.
Sensodyne Rapid Action Trademark Dentifrices : 8% Strontium Acetate with tubular occluding formulation.
|
Colgate Total
n=20 Participants
Participants received Colgate Total dentifrices and instructed to brush their teeth with a full strip of dentifrices on a dry toothbrush for 1 minute twice daily for 4 weeks.
Colgate Total Trademark Dentifrices : Sodium Fluoride with no claim of relieving Dentin Hypersensitivity
|
|---|---|---|---|---|
|
Percent Change in Mean Scores of Pain Response From Baseline on Visual Analog Scale Using Water Jet Stimulus
1-minute
|
22 percentage of change in mean scores
Standard Deviation 21
|
52 percentage of change in mean scores
Standard Deviation 26
|
46 percentage of change in mean scores
Standard Deviation 25
|
18 percentage of change in mean scores
Standard Deviation 15
|
|
Percent Change in Mean Scores of Pain Response From Baseline on Visual Analog Scale Using Water Jet Stimulus
5-minutes
|
27 percentage of change in mean scores
Standard Deviation 22
|
56 percentage of change in mean scores
Standard Deviation 25
|
52 percentage of change in mean scores
Standard Deviation 24
|
21 percentage of change in mean scores
Standard Deviation 17
|
|
Percent Change in Mean Scores of Pain Response From Baseline on Visual Analog Scale Using Water Jet Stimulus
Day-3
|
30 percentage of change in mean scores
Standard Deviation 29
|
34 percentage of change in mean scores
Standard Deviation 22
|
32 percentage of change in mean scores
Standard Deviation 21
|
18 percentage of change in mean scores
Standard Deviation 16
|
|
Percent Change in Mean Scores of Pain Response From Baseline on Visual Analog Scale Using Water Jet Stimulus
Week-4
|
67 percentage of change in mean scores
Standard Deviation 25
|
57 percentage of change in mean scores
Standard Deviation 23
|
55 percentage of change in mean scores
Standard Deviation 22
|
29 percentage of change in mean scores
Standard Deviation 20
|
Adverse Events
BioMin F Dentifrices
Colgate Sensitive Pro Relief Trade Mark Dentifrices
Sensodyne Rapid Action Trade Mark Dentifrices
Colgate Total Trade Mark
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Syed Jaffar Abbas Zaidi
Dow University of Health Sciences
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place