Dentin SensitivityPhase 4NCT07871786
Efficacy of a Sonic Toothbrush and 8% Arginine Toothpaste in Reducing Dentinal Hypersensitivity
A Phase 4 study testing 8.0% Arginine Dentifrice, Electric Sonic Toothbrush and Adult Soft Bristle Manual Toothbrush in people with Dentin Sensitivity and Dentin Hypersensitivity, run by Colgate Palmolive at 1 site in Brazil.
Trial summary
This clinical study evaluates the efficacy of an oral hygiene regimen consisting of an electric sonic toothbrush used in combination with an 8.0% arginine and calcium carbonate toothpaste in reducing dentinal hypersensitivity compared to a manual soft-bristled toothbrush with the same desensitizing toothpaste. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Dentin Sensitivity, Dentin Hypersensitivity
- What is being tested?
- 8.0% Arginine Dentifrice, Electric Sonic Toothbrush and Adult Soft Bristle Manual Toothbrush
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteBrazil
- Study dates
- 6 Dec 2021to 14 Feb 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sign an Informed Consent Form.
- Male or female between 18 and 70 years of age, inclusive.
- In good general health as determined by the study investigators.
- Available for the seven (7) days duration of the study.
- Present two (2) sensitive teeth anterior to the molars demonstrating dentin exposure due to cervical erosion/abrasion and/or gingival recession.
- Present a qualifying dentin hypersensitivity response to air blast stimuli applied for 1 second to the cervical surface (gingivo-facial 1/3) defined by a score of 2 or 3 on the Schiff Cold Air Sensitivity Scale.
Who cannot join
- Presence of gross oral pathology, chronic disease, or history of allergies to test products.
- Use of a desensitizing oral care product or recipient of dental desensitizing treatment within 1 month prior to study start.
- Advanced periodontal disease or periodontal treatment (including surgery) within 12 months prior to study start (routine dental cleaning is permitted).
- Sensitive teeth with mobility greater than 1.
- Sensitive teeth with extensive or defective restorations (including crowns), suspected pulpitis, caries, cracked enamel, or used as abutments for removable partial dentures.
- Current use of anticonvulsants, antihistamines, antidepressants, sedatives, tranquilizers, anti-inflammatory drugs, or daily use of analgesics that could affect pain sensation.
Show all 11Show fewer
- Current smokers.
- Concurrent participation in any other oral clinical study.
- Self-reported pregnancy or currently breastfeeding.
- Known allergy to oral care products, personal care consumer products, or their ingredients.
- Existing medical condition prohibiting fasting from food or liquid for up to 4 hours.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
The Federal University of Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, 90040-060
About this study
Official title: Clinical Investigation to Assess the Efficacy of a Sonic Toothbrush and a Toothpaste Containing 8.0% Arginine and Calcium Carbonate in Reducing Dentinal Hypersensitivity
This clinical study evaluates the efficacy of an oral hygiene regimen consisting of an electric sonic toothbrush used in combination with an 8.0% arginine and calcium carbonate toothpaste in reducing dentinal hypersensitivity compared to a manual soft-bristled toothbrush with the same desensitizing toothpaste. Adult participants with tactile/air-blast hypersensitive teeth brush twice daily for 7 days. Sensitivity reductions are evaluated at baseline, immediately post-brushing, at 3 days, and at 7 days.
Read the detailed description
Dentinal hypersensitivity is a common oral condition characterized by short, sharp pain arising from exposed dentin in response to external stimuli. This single-center, Phase III, randomized, examiner-blind, 2-arm parallel-group clinical trial investigates the efficacy of combining an electric sonic toothbrush with an 8.0% arginine and calcium carbonate toothpaste to alleviate dentinal hypersensitivity.
Eighty adult participants meeting inclusion and exclusion criteria are randomized (1:1 ratio) into two study groups:
- Test Group: Electric sonic toothbrush + 8.0% arginine fluoride toothpaste.
- Positive Control Group: Adult soft-bristled manual toothbrush + 8.0% arginine fluoride toothpaste.
Sequence of Study Procedures:
- Screening \& Baseline Visit (Visit 1): Participants undergo oral soft tissue examinations and air-blast hypersensitivity evaluations. Eligible participants present at least two qualifying sensitive teeth demonstrating cervical erosion/abrasion or gingival recession with a Schiff Cold Air Sensitivity Scale score of 2 or 3.
- Immediate Post-Brushing Assessment: Immediately following baseline evaluations, participants perform supervised in-office brushing with their assigned regimen for 2 minutes and 30 seconds, followed by an immediate post-brushing sensitivity re-evaluation.
- Home Usage: Participants are dispensed their assigned regimen and instructed to brush for 2 minutes twice daily (morning and evening) for 7 days. 4- Follow-Up Visits: Dentinal hypersensitivity and oral soft tissue status are re-evaluated after 3 days (Visit 2) and 7 days (Visit 3) of product use.
- Conditions
- Dentin Sensitivity, Dentin Hypersensitivity
- Being tested
- 8.0% Arginine Dentifrice, Electric Sonic Toothbrush, Adult Soft Bristle Manual Toothbrush
- Keywords
- Arginine, Sonic Toothbrush, Dentinal Hypersensitivity, Schiff Cold Air Sensitivity Scale
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
8.0% Arginine DentifriceDrug
Commercial fluoride toothpaste containing 8.0% arginine and calcium carbonate.
Electric Sonic ToothbrushDevice
Commercially available electric sonic toothbrush.
Adult Soft Bristle Manual ToothbrushDevice
Commercially available adult soft bristle manual toothbrush (ADA reference).
| Study group | Role | What they receive |
|---|---|---|
| Test Group (Sonic Toothbrush + 8% Arginine Toothpaste) | Experimental | Participants brush twice daily (morning and evening) for 2 minutes using an electric sonic toothbrush and an 8.0% arginine fluoride toothpaste for 7 days. Receives: Drug: 8.0% Arginine Dentifrice; Device: Electric Sonic Toothbrush |
| Positive Control Group (Manual Toothbrush + 8% Arginine Toothpaste) | Active comparator | Participants brush twice daily (morning and evening) for 2 minutes using an adult soft-bristled manual toothbrush and an 8.0% arginine fluoride toothpaste for 7 days. Receives: Drug: 8.0% Arginine Dentifrice; Device: Adult Soft Bristle Manual Toothbrush |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Dentinal Hypersensitivity Score (Schiff Cold Air Sensitivity Scale)
Assessment of tooth sensitivity to air blast stimuli applied for 1 second to the exposed cervical surface of qualifying teeth, scored using the Schiff Cold Air Sensitivity Scale (range 0-3, where 0 = no response and 3 = painful response/requests discontinuation)
Measured: Baseline, immediately post-brushing, Day 3, and Day 7.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start6 Dec 2021
- Primary completion14 Feb 2022
- Study completion14 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dentin SensitivityStudies of the same condition, open and under way.
- More trials run by Colgate PalmoliveThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-center, randomized, examiner-blind, 2-arm parallel-group clinical trial.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colgate Palmolive
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Federal University of Rio Grande do Sul
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07871786
- Sponsor's protocol ID
- CRO-2021-06-SEN-ETB-BZ-BS
- Status last verified
- Oct 2026
- First submitted
- 8 Oct 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared to maintain confidentiality as outlined in the subject consent and privacy terms.
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation to Assess the Efficacy of a Sonic Toothbrush and a Toothpaste Containing 8.0% Arginine and Calcium Carbonate in Reducing Dentinal Hypersensitivity
- ClinicalTrials.gov ID
- NCT07871786
- Acronym / sponsor ID
- CRO-2021-06-SEN-ETB-BZ-BS
- Conditions
- Dentin Sensitivity, Dentin Hypersensitivity
- Keywords
- Arginine, Sonic Toothbrush, Dentinal Hypersensitivity, Schiff Cold Air Sensitivity Scale
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Colgate PalmoliveIndustry (pharma, biotech, devices)
- Collaborators
- Federal University of Rio Grande do Sul
- Study start
- 6 Dec 2021 (actual)
- Primary completion
- 14 Feb 2022 (actual)
- Study completion
- 14 Feb 2022 (actual)
- First posted
- 13 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical study evaluates the efficacy of an oral hygiene regimen consisting of an electric sonic toothbrush used in combination with an 8.0% arginine and calcium carbonate toothpaste in reducing dentinal hypersensitivity compared to a manual soft-bristled toothbrush with the same desensitizing toothpaste. Adult participants with tactile/air-blast hypersensitive teeth brush twice daily for 7 days. Sensitivity reductions are evaluated at baseline, immediately post-brushing, at 3 days, and at 7 days.
Detailed description
Dentinal hypersensitivity is a common oral condition characterized by short, sharp pain arising from exposed dentin in response to external stimuli. This single-center, Phase III, randomized, examiner-blind, 2-arm parallel-group clinical trial investigates the efficacy of combining an electric sonic toothbrush with an 8.0% arginine and calcium carbonate toothpaste to alleviate dentinal hypersensitivity.
Eighty adult participants meeting inclusion and exclusion criteria are randomized (1:1 ratio) into two study groups:
- Test Group: Electric sonic toothbrush + 8.0% arginine fluoride toothpaste.
- Positive Control Group: Adult soft-bristled manual toothbrush + 8.0% arginine fluoride toothpaste.
Sequence of Study Procedures:
- Screening \& Baseline Visit (Visit 1): Participants undergo oral soft tissue examinations and air-blast hypersensitivity evaluations. Eligible participants present at least two qualifying sensitive teeth demonstrating cervical erosion/abrasion or gingival recession with a Schiff Cold Air Sensitivity Scale score of 2 or 3.
- Immediate Post-Brushing Assessment: Immediately following baseline evaluations, participants perform supervised in-office brushing with their assigned regimen for 2 minutes and 30 seconds, followed by an immediate post-brushing sensitivity re-evaluation.
- Home Usage: Participants are dispensed their assigned regimen and instructed to brush for 2 minutes twice daily (morning and evening) for 7 days. 4- Follow-Up Visits: Dentinal hypersensitivity and oral soft tissue status are re-evaluated after 3 days (Visit 2) and 7 days (Visit 3) of product use.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Single-center, randomized, examiner-blind, 2-arm parallel-group clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Test Group (Sonic Toothbrush + 8% Arginine Toothpaste) | Experimental | Drug: 8.0% Arginine Dentifrice, Device: Electric Sonic ToothbrushParticipants brush twice daily (morning and evening) for 2 minutes using an electric sonic toothbrush and an 8.0% arginine fluoride toothpaste for 7 days. |
| Positive Control Group (Manual Toothbrush + 8% Arginine Toothpaste) | Active comparator | Drug: 8.0% Arginine Dentifrice, Device: Adult Soft Bristle Manual ToothbrushParticipants brush twice daily (morning and evening) for 2 minutes using an adult soft-bristled manual toothbrush and an 8.0% arginine fluoride toothpaste for 7 days. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Sign an Informed Consent Form.
- Male or female between 18 and 70 years of age, inclusive.
- In good general health as determined by the study investigators.
- Available for the seven (7) days duration of the study.
- Present two (2) sensitive teeth anterior to the molars demonstrating dentin exposure due to cervical erosion/abrasion and/or gingival recession.
Key exclusion criteria (11 listed)
- Presence of gross oral pathology, chronic disease, or history of allergies to test products.
- Use of a desensitizing oral care product or recipient of dental desensitizing treatment within 1 month prior to study start.
- Advanced periodontal disease or periodontal treatment (including surgery) within 12 months prior to study start (routine dental cleaning is permitted).
- Sensitive teeth with mobility greater than 1.
- Sensitive teeth with extensive or defective restorations (including crowns), suspected pulpitis, caries, cracked enamel, or used as abutments for removable partial dentures.
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 |
|---|---|---|
| 8.0% Arginine DentifriceCommercial fluoride toothpaste containing 8.0% arginine and calcium carbonate. | Drug | Positive Control Group (Manual Toothbrush + 8% Arginine Toothpaste), Test Group (Sonic Toothbrush + 8% Arginine Toothpaste) |
| Electric Sonic ToothbrushCommercially available electric sonic toothbrush. | Device | Test Group (Sonic Toothbrush + 8% Arginine Toothpaste) |
| Adult Soft Bristle Manual ToothbrushCommercially available adult soft bristle manual toothbrush (ADA reference). | Device | Positive Control Group (Manual Toothbrush + 8% Arginine Toothpaste) |
Primary outcome
Change in Dentinal Hypersensitivity Score (Schiff Cold Air Sensitivity Scale)
Time frame: Baseline, immediately post-brushing, Day 3, and Day 7.
Assessment of tooth sensitivity to air blast stimuli applied for 1 second to the exposed cervical surface of qualifying teeth, scored using the Schiff Cold Air Sensitivity Scale (range 0-3, where 0 = no response and 3 = painful response/requests discontinuation)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared to maintain confidentiality as outlined in the subject consent and privacy terms.
Related trials for Dentin Sensitivity
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
Dentin Sensitivity
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
Tooth Discoloration, Tooth Staining
Recruiting
Dentine Hypersensitivity Using Dentine Adhesive With Strontium-doped Bioactive Glass-Ceramic
Dentine Hypersensitivity
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 8.0% Arginine Dentifrice, Electric Sonic Toothbrush and Adult Soft Bristle Manual Toothbrush in people with Dentin Sensitivity and Dentin Hypersensitivity, run by Colgate Palmolive at 1 site in Brazil.
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 6 inclusion and 11 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 16 Oct 2026. 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 Brazil. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Dentinal Hypersensitivity Score (Schiff Cold Air Sensitivity Scale) (time frame: Baseline, immediately post-brushing, Day 3, and Day 7.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Oct 2026.