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

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

140 participants

Primary outcome timeframe

(Base line to 1 minute) (Base line to 5 minutes)(Base line to day 3)(Base line to week 4)

Results posted on

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

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

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

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

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

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

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

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Colgate Sensitive Pro Relief Trade Mark Dentifrices

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Sensodyne Rapid Action Trade Mark Dentifrices

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Colgate Total Trade Mark

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

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

Phone: 00923412481371

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place