Trial · NCT04249336
Clinical Efficacy Of BioMin F, Colgate Sensitive Pro-Relief And Sensodyne Rapid Action Dentifrices In DH
NCT04249336, Phase 3, Completed, Dow University of Health Sciences; results first posted 2021-05-11
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Clinical Efficacy Of BioMin F, Colgate Sensitive Pro-Relief And Sensodyne Rapid Action Dentifrices In DH. Trials, record NCT04249336. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04249336
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clinical Efficacy Of BioMin F, Colgate Sensitive Pro-Relief And Sensodyne Rapid Action Dentifrices In DH
- NCT number
- NCT04249336
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 140 participants, actual
- Lead sponsor
- Dow University of Health Sciences
- Conditions
- Dentin Hypersensitivity
- Interventions
- Fluoro-Calcium-Phospho-Silicate based dentifrices, 8% Arginine based dentifrices, 8% Strontium Acetate, Sodium Fluoride
- First posted
- 2020-01-30
- Last updated
- 2021-05-11
- Results first posted
- 2021-05-11
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change in Mean Score of Pain Response From Baseline on Schiff Cold Air Sensitivity Scale Using Air Blast Stimulus | (Base line to 1 minute) (Base line to 5 minutes)(Base line to day 3)(Base line to week 4) | 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 |
| Secondary | Percent Change in Mean Scores of Pain Response From Baseline on Visual Analog Scale Using Mechanical Stimulus | (Base line to 1 minute) (Base line to 5 minutes)(Base line to day 3)(Base line to week 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 |
| Secondary | Percent Change in Mean Scores of Pain Response From Baseline on Visual Analog Scale Using Water Jet Stimulus | (Base line to 1 minute) (Base line to 5 minutes)(Base line to day 3)(Base line to week 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 |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change in Mean Score of Pain Response From Baseline on Schiff Cold Air Sensitivity Scale Using Air Blast Stimulus | (Base line to 1 minute) (Base line to 5 minutes)(Base line to day 3)(Base line to week 4) | 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. | percentage of change in mean scores | MEAN |
| SECONDARY | Percent Change in Mean Scores of Pain Response From Baseline on Visual Analog Scale Using Mechanical Stimulus | (Base line to 1 minute) (Base line to 5 minutes)(Base line to day 3)(Base line to week 4) | 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. | percentage of change in mean scores | MEAN |
| SECONDARY | Percent Change in Mean Scores of Pain Response From Baseline on Visual Analog Scale Using Water Jet Stimulus | (Base line to 1 minute) (Base line to 5 minutes)(Base line to day 3)(Base line to week 4) | 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. | percentage of change in mean scores | MEAN |
Source ClinicalTrials.gov
Results by group48
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change in Mean Score of Pain Response From Baseline on Schiff Cold Air Sensitivity Scale Using Air Blast Stimulus | BioMin F | 1- minute | 18 | Standard Deviation 21 | percentage of change in mean scores |
| Percent Change in Mean Score of Pain Response From Baseline on Schiff Cold Air Sensitivity Scale Using Air Blast Stimulus | Colgate Sensitive Pro Relief | 1- minute | 45 | Standard Deviation 24 | percentage of change in mean scores |
| Percent Change in Mean Score of Pain Response From Baseline on Schiff Cold Air Sensitivity Scale Using Air Blast Stimulus | Sensodyne Rapid Action | 1- minute | 37 | Standard Deviation 27 | percentage of change in mean scores |
| Percent Change in Mean Score of Pain Response From Baseline on Schiff Cold Air Sensitivity Scale Using Air Blast Stimulus | Colgate Total | 1- minute | 15 | Standard Deviation 22 | percentage of change in mean scores |
| Percent Change in Mean Score of Pain Response From Baseline on Schiff Cold Air Sensitivity Scale Using Air Blast Stimulus | BioMin F | 5-minutes | 27 | Standard Deviation 22 | percentage of change in mean scores |
| Percent Change in Mean Score of Pain Response From Baseline on Schiff Cold Air Sensitivity Scale Using Air Blast Stimulus | Colgate Sensitive Pro Relief | 5-minutes | 56 | Standard Deviation 25 | percentage of change in mean scores |
| Percent Change in Mean Score of Pain Response From Baseline on Schiff Cold Air Sensitivity Scale Using Air Blast Stimulus | Sensodyne Rapid Action | 5-minutes | 51 | Standard Deviation 28 | percentage of change in mean scores |
| Percent Change in Mean Score of Pain Response From Baseline on Schiff Cold Air Sensitivity Scale Using Air Blast Stimulus | Colgate Total | 5-minutes | 19 | Standard Deviation 21 | percentage of change in mean scores |
| Percent Change in Mean Score of Pain Response From Baseline on Schiff Cold Air Sensitivity Scale Using Air Blast Stimulus | BioMin F | Day-3 | 22 | Standard Deviation 22 | percentage of change in mean scores |
| Percent Change in Mean Score of Pain Response From Baseline on Schiff Cold Air Sensitivity Scale Using Air Blast Stimulus | Colgate Sensitive Pro Relief | Day-3 | 24 | Standard Deviation 21 | percentage of change in mean scores |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 results by groupParticipant flow20
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Colgate Sensitive Pro Relief | 35 | |
| Overall Study | STARTED | BioMin F | 35 | |
| Overall Study | STARTED | Sensodyne Rapid Action | 35 | |
| Overall Study | STARTED | Colgate Total | 35 | |
| Overall Study | Per Protocol Population Day 3 | Colgate Sensitive Pro Relief | 32 | |
| Overall Study | Per Protocol Population Day 3 | BioMin F | 32 | |
| Overall Study | Per Protocol Population Day 3 | Sensodyne Rapid Action | 32 | |
| Overall Study | Per Protocol Population Day 3 | Colgate Total | 32 | |
| Overall Study | Per Protocol Population Week 4 | Colgate Sensitive Pro Relief | 33 | |
| Overall Study | Per Protocol Population Week 4 | BioMin F | 35 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 participant flowAdverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | BioMin F Dentifrices | 0 | 35 |
| Total, all-cause mortality | Colgate Sensitive Pro Relief Trade Mark Dentifrices | 0 | 35 |
| Total, all-cause mortality | Sensodyne Rapid Action Trade Mark Dentifrices | 0 | 35 |
| Total, all-cause mortality | Colgate Total Trade Mark | 0 | 35 |
| Total, other adverse events | BioMin F Dentifrices | 0 | 35 |
| Total, other adverse events | Colgate Sensitive Pro Relief Trade Mark Dentifrices | 0 | 35 |
| Total, other adverse events | Sensodyne Rapid Action Trade Mark Dentifrices | 0 | 35 |
| Total, other adverse events | Colgate Total Trade Mark | 0 | 35 |
| Total, serious adverse events | BioMin F Dentifrices | 0 | 35 |
| Total, serious adverse events | Colgate Sensitive Pro Relief Trade Mark Dentifrices | 0 | 35 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04249336
GET https://conductscience.org/api/trials/v1/NCT04249336/results?page=2