Dentin HypersensitivityPhase 3NCT04249336

Clinical Efficacy Of BioMin F, Colgate Sensitive Pro-Relief And Sensodyne Rapid Action Dentifrices In DH

A Phase 3 study testing Fluoro-Calcium-Phospho-Silicate based dentifrices, 8% Arginine based dentifrices and 8% Strontium Acetate in people with Dentin Hypersensitivity, run by Dow University of Health Sciences at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This will be multi-centered, triple blinded, randomized, four parallel treatments assigned study to compare clinical efficacy of commercially available dentifrices with placebo for immediate and sustained relief from Dentin Hypersensitivity after short term use. Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Dentin Hypersensitivity
What is being tested?: Fluoro-Calcium-Phospho-Silicate based dentifrices, 8% Arginine based dentifrices and 8% Strontium Acetate
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 140 participants
Where: 1 sitePakistan
Study dates: 27 Sep 2019to 16 Jan 2021
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Subjects with at least two teeth sensitive to cold, touch and air blow stimulus
Sensitive teeth anterior to molars either due to erosions or abrasions with or without associated gingival recession
Teeth with Linear Visual Analogue Scale (VAS) score of ≥ 4 and code 2 of Schiff Cold Air Sensitivity Scale on screening.

Who cannot join

Subjects with worst pain response at 100mm on VAS.(Visual Analog Scale)
Teeth with orthodontic or prosthetic appliances, Caries, restorations or cracks
Localized or generalized gingivitis or pulpitis with heavy calculus
Periodontal surgery in the preceding three months
Patients using any desensitizing tooth paste or mouth wash up to six weeks before study and taking drugs like anti-inflammatory, sedatives, tranquilizers, analgesics in routine.
Pregnant or breastfeeding females.

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

Dr Syed Jaffar Abbas Zaidi
Karachi, Sindh, 74600

Other trials in Pakistan

About this study

Official title: Immediate And Sustained Treatment Response Of Commercially Available BioMin F, Colgate Sensitive Pro-Relief And Sensodyne Rapid Action Dentifrices In Dentin Hypersensitivity - "A Randomized Clinical Trial"

Condition or disease: Dentin hypersensitivity Intervention/Treatment: Product 1; Fluoro-Calcium-Phospho-silicate based BioMin F Product 2; Pro-Argin formula based Colgate Sensitive Pro-Relief Product 3; Strontium Acetate based Sensodyne Rapid Action Product 4; Sodium Fluoride based Colgate Total

Read the detailed description

It is a randomized controlled clinical trial with non invasive topical intervention in 140 adult patients of 18 to 60 years age, that will be selected randomly after screening and diagnosis of dentin hypersensitivity, in dental Out Patient Department of Periodontology. Written informed consent will be obtained. Participants will be allocated randomly into four equal study arms for parallel treatment assignment with dentifrices named BioMin F, Colgate Sensitive Pro-Relief Trade Mark,Sensodyne rapid action Trade Mark and Colgate Total Trade Mark dentifrices. Colgate total Trade Mark dentifrices does not claim pain relief in Dentin Hypersensitivity. Interim efficacy will be assessed immediately after topical application on sensitive teeth, in one minute, after 5 minutes, on day three and week 4 respectively. Dentin hypersensitivity will be tested with mechanical stimulus, evaporative air blast stimulus and water jet stimulus. It will be measured on Visual Analogue Scale and Schiff cold air sensitivity scale (SCASS). Statistical analysis will be done using ANOVA in Statistical Package for Social Sciences software 21.

Conditions: Dentin Hypersensitivity
Being tested: Fluoro-Calcium-Phospho-Silicate based dentifrices, 8% Arginine based dentifrices, 8% Strontium Acetate, Sodium Fluoride
Keywords: Dentine hypersensitivity, Dentine Sensitivity, Oral dentifrices, Bio-active glasses
Medical subject headings: Dentin Sensitivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Fluoro-Calcium-Phospho-Silicate based dentifricesDrug
Also called BioMin F
Bio-Active glass based formulation
8% Arginine based dentifricesDrug
Also called Colgate Sensitive Pro-Relief TM
Tubular occluding formulation
8% Strontium AcetateDrug
Also called Sensodyne Rapid ActionTM
Tubular occluding formulation
Sodium FluorideDrug
Also called Colgate Total TM
No claim of relieving Dentin Hypersensitivity

Study groups in NCT04249336
Study group	Role	What they receive
BioMin F Dentifrices	Experimental	Participants will be instructed to dose a dry toothbrush with a full strip of dentifrices and to brush teeth for 1 minute twice daily. Receives: Drug: Fluoro-Calcium-Phospho-Silicate based dentifrices
Colgate Sensitive Pro relief Trade Mark Dentifrices	Active comparator	Participants will be instructed to dose a dry toothbrush with a full strip of dentifrices and to brush teeth for 1 minute twice daily. Receives: Drug: 8% Arginine based dentifrices
Sensodyne Rapid Action Trade Mark Dentifrices	Active comparator	Participants will be instructed to dose a dry toothbrush with a full strip of dentifrices and to brush teeth for 1 minute twice daily. Receives: Drug: 8% Strontium Acetate
Colgate Total Trade Mark	Placebo comparator	Participants will be instructed to dose a dry toothbrush with a full strip of dentifrices and to brush teeth for 1 minute twice daily. Receives: Drug: Sodium Fluoride

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent Change in Mean Score of Pain Response From Baseline on Schiff Cold Air Sensitivity Scale Using Air Blast Stimulus
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
Measured: (Base line to 1 minute) (Base line to 5 minutes)(Base line to day 3)(Base line to week 4)

Secondary outcomes (2)

Percent Change in Mean Scores of Pain Response From Baseline on Visual Analog Scale Using Mechanical Stimulus
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
Measured: (Base line to 1 minute) (Base line to 5 minutes)(Base line to day 3)(Base line to week 4)
Percent Change in Mean Scores of Pain Response From Baseline on Visual Analog Scale Using Water Jet Stimulus
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
Measured: (Base line to 1 minute) (Base line to 5 minutes)(Base line to day 3)(Base line to week 4)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Sep 201916 Jan 2021

First posted30 Jan 2020
Study start27 Sep 2019
Primary completion16 Jan 2021
Study completion16 Jan 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Dentin HypersensitivityStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 140 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04249336
Sponsor's protocol ID: PRS4072
Status last verified: Apr 2021
First submitted: 26 Sep 2019
Last updated: 11 May 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Hall C, Mason S, Cooke J. Exploratory randomised controlled clinical study to evaluate the comparative efficacy of two occluding toothpastes - a 5% calcium sodium phosphosilicate toothpaste and an 8% arginine/calcium carbonate toothpaste - for the longer-term relief of dentine hypersensitivity. J Dent. 2017 May;60:36-43. doi: 10.1016/j.jdent.2017.02.009. Epub 2017 Feb 20.
PubMed 28219674
Ashwini S, Swatika K, Kamala DN. Comparative Evaluation of Desensitizing Efficacy of Dentifrice Containing 5% Fluoro Calcium Phosphosilicate versus 5% Calcium Sodium Phosphosilicate: A Randomized Controlled Clinical Trial. Contemp Clin Dent. 2018 Jul-Sep;9(3):330-336. doi: 10.4103/ccd.ccd_735_17.
PubMed 30166822
Arshad S, Zaidi SJA, Farooqui WA. Comparative efficacy of BioMin-F, Colgate Sensitive Pro-relief and Sensodyne Rapid Action in relieving dentin hypersensitivity: a randomized controlled trial. BMC Oral Health. 2021 Oct 6;21(1):498. doi: 10.1186/s12903-021-01864-x.
PubMed 34615511

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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The Effect of Decoupling With Time Technique on the Clinical Performance of Proximal Posterior Composite Restorations
Dental Restoration Failure, Postoperative Hypersensitivity
Recruiting
A Study to Assess the Efficacy of a Calcium Sodium Phosphosilicate Toothpaste for the Relief of Dentine Hypersensitivity
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Active, not recruiting
Clinical Evaluation of Short Dentin Etching
Hypersensitivity Dentin, Dental Restoration Failure of Marginal Integrity
Recruiting
Peroxide Versus Non-Peroxide In-Office Tooth Bleaching
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Dentine Hypersensitivity Using Dentine Adhesive With Strontium-doped Bioactive Glass-Ceramic
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All Dentin Hypersensitivity trials

Study at a glance

From the registry record, last updated by the sponsor on 11 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Immediate And Sustained Treatment Response Of Commercially Available BioMin F, Colgate Sensitive Pro-Relief And Sensodyne Rapid Action Dentifrices In Dentin Hypersensitivity - "A Randomized Clinical Trial"
ClinicalTrials.gov ID: NCT04249336
Acronym / sponsor ID: PRS4072
Conditions: Dentin Hypersensitivity
Keywords: Dentine hypersensitivity, Dentine Sensitivity, Oral dentifrices, Bio-active glasses
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 140 participants (actual)
Lead sponsor: Dow University of Health SciencesUniversity, hospital or other
Study start: 27 Sep 2019 (actual)
Primary completion: 16 Jan 2021 (actual)
Study completion: 16 Jan 2021 (actual)
First posted: 30 Jan 2020 (actual)
Results: Posted 11 May 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
BioMin F Dentifrices	Experimental	Drug: Fluoro-Calcium-Phospho-Silicate based dentifricesParticipants will be instructed to dose a dry toothbrush with a full strip of dentifrices and to brush teeth for 1 minute twice daily.
Colgate Sensitive Pro relief Trade Mark Dentifrices	Active comparator	Drug: 8% Arginine based dentifricesParticipants will be instructed to dose a dry toothbrush with a full strip of dentifrices and to brush teeth for 1 minute twice daily.
Sensodyne Rapid Action Trade Mark Dentifrices	Active comparator	Drug: 8% Strontium AcetateParticipants will be instructed to dose a dry toothbrush with a full strip of dentifrices and to brush teeth for 1 minute twice daily.
Colgate Total Trade Mark	Placebo comparator	Drug: Sodium FluorideParticipants will be instructed to dose a dry toothbrush with a full strip of dentifrices and to brush teeth for 1 minute twice daily.

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Subjects with at least two teeth sensitive to cold, touch and air blow stimulus
Sensitive teeth anterior to molars either due to erosions or abrasions with or without associated gingival recession
Teeth with Linear Visual Analogue Scale (VAS) score of ≥ 4 and code 2 of Schiff Cold Air Sensitivity Scale on screening.

Key exclusion criteria (6 listed)

Subjects with worst pain response at 100mm on VAS.(Visual Analog Scale)
Teeth with orthodontic or prosthetic appliances, Caries, restorations or cracks
Localized or generalized gingivitis or pulpitis with heavy calculus
Periodontal surgery in the preceding three months
Patients using any desensitizing tooth paste or mouth wash up to six weeks before study and taking drugs like anti-inflammatory, sedatives, tranquilizers, analgesics in routine.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Fluoro-Calcium-Phospho-Silicate based dentifricesAlso: BioMin FBio-Active glass based formulation	Drug	BioMin F Dentifrices
8% Arginine based dentifricesAlso: Colgate Sensitive Pro-Relief TMTubular occluding formulation	Drug	Colgate Sensitive Pro relief Trade Mark Dentifrices
8% Strontium AcetateAlso: Sensodyne Rapid ActionTMTubular occluding formulation	Drug	Sensodyne Rapid Action Trade Mark Dentifrices
Sodium FluorideAlso: Colgate Total TMNo claim of relieving Dentin Hypersensitivity	Drug	Colgate Total Trade Mark

Primary outcome

Percent Change in Mean Score of Pain Response From Baseline on Schiff Cold Air Sensitivity Scale Using Air Blast Stimulus
Time frame: (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

2 secondary outcomes

Percent Change in Mean Scores of Pain Response From Baseline on Visual Analog Scale Using Mechanical Stimulus
Time frame: (Base line to 1 minute) (Base line to 5 minutes)(Base line to day 3)(Base line to week 4)
Percent Change in Mean Scores of Pain Response From Baseline on Visual Analog Scale Using Water Jet Stimulus
Time frame: (Base line to 1 minute) (Base line to 5 minutes)(Base line to day 3)(Base line to week 4)

Results and safety

Results posted to the registry on 11 May 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Colgate Sensitive Pro Relief	35	32
BioMin F	35	32
Sensodyne Rapid Action	35	32
Colgate Total	35	32

Primary outcome: Percent Change in Mean Score of Pain Response From Baseline on Schiff Cold Air Sensitivity Scale Using Air Blast Stimulus

Time frame: (Base line to 1 minute) (Base line to 5 minutes)(Base line to day 3)(Base line to week 4). Mean (Standard Deviation). Unit: percentage of change in mean scores

Measure	BioMin F n = 32	Colgate Sensitive Pro Relief n = 32	Sensodyne Rapid Action n = 32	Colgate Total n = 32
1- minute	18 (21)	45 (24)	37 (27)	15 (22)
5-minutes	27 (22)	56 (25)	51 (28)	19 (21)
Day-3	22 (22)	24 (21)	25 (21)	10 (18)
Week-4	58 (26)	55 (24)	45 (25)	22 (24)

BioMin F vs Colgate Total: Mean Difference (Net): 36, p <0.05, ANOVA
Colgate Sensitive Pro Relief vs Colgate Total: Mean Difference (Net): 33, p <0.05, ANOVA
Sensodyne Rapid Action vs Colgate Total: Mean Difference (Net): 23, p <0.05, ANOVA

Population analysed: 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.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BioMin F Dentifrices	0 of 35 (0%)	0 of 35 (0%)	0 of 35
Colgate Sensitive Pro Relief Trade Mark Dentifrices	0 of 35 (0%)	0 of 35 (0%)	0 of 35
Sensodyne Rapid Action Trade Mark Dentifrices	0 of 35 (0%)	0 of 35 (0%)	0 of 35
Colgate Total Trade Mark	0 of 35 (0%)	0 of 35 (0%)	0 of 35

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 28219674Hall C, Mason S, Cooke J. Exploratory randomised controlled clinical study to evaluate the comparative efficacy of two occluding toothpastes - a 5% calcium sodium phosphosilicate toothpaste and an 8% arginine/calcium carbonate toothpaste - for the longer-term relief of dentine hypersensitivity. J Dent. 2017 May;60:36-43. doi: 10.1016/j.jdent.2017.02.009. Epub 2017 Feb 20.
Background: PubMed 30166822Ashwini S, Swatika K, Kamala DN. Comparative Evaluation of Desensitizing Efficacy of Dentifrice Containing 5% Fluoro Calcium Phosphosilicate versus 5% Calcium Sodium Phosphosilicate: A Randomized Controlled Clinical Trial. Contemp Clin Dent. 2018 Jul-Sep;9(3):330-336. doi: 10.4103/ccd.ccd_735_17.
Derived from this study: PubMed 34615511Arshad S, Zaidi SJA, Farooqui WA. Comparative efficacy of BioMin-F, Colgate Sensitive Pro-relief and Sensodyne Rapid Action in relieving dentin hypersensitivity: a randomized controlled trial. BMC Oral Health. 2021 Oct 6;21(1):498. doi: 10.1186/s12903-021-01864-x.

Related trials for Dentin Hypersensitivity

Not yet recruiting
The Effect of Decoupling With Time Technique on the Clinical Performance of Proximal Posterior Composite Restorations
Dental Restoration Failure, Postoperative Hypersensitivity
Recruiting
A Study to Assess the Efficacy of a Calcium Sodium Phosphosilicate Toothpaste for the Relief of Dentine Hypersensitivity
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Active, not recruiting
Clinical Evaluation of Short Dentin Etching
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Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Syed Jaffar Abbas Zaidi study director

Dow University of Health Sciences

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change in Mean Score of Pain Response From Baseline on Schiff Cold Air Sensitivity Scale Using Air Blast Stimulus (time frame: (Base line to 1 minute) (Base line to 5 minutes)(Base line to day 3)(Base line to week 4)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04249336, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2021.