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CompletedNCT07871786Updated Oct 16, 2026

Efficacy of a Sonic Toothbrush and 8% Arginine Toothpaste in Reducing Dentinal Hypersensitivity

A Phase 4 interventional study of 8.0% Arginine Dentifrice and Electric Sonic Toothbrush in Dentin Sensitivity and Dentin Hypersensitivity, sponsored by Colgate Palmolive. Completed at 1 site in Brazil. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-16.

Sponsored by Colgate Palmolive · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Registered 4 years 10 months after the study started (first participant enrolled Dec 2021, registered Oct 2026).
Updated Oct 13, 2026Newly registeredGo to Updates ↓
Phase
Phase 4
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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. 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:

  1. Test Group: Electric sonic toothbrush + 8.0% arginine fluoride toothpaste.
  2. Positive Control Group: Adult soft-bristled manual toothbrush + 8.0% arginine fluoride toothpaste.

Sequence of Study Procedures:

  1. 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.
  2. 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.
  3. 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.
02

Conditions studied

  • Dentin Sensitivity
  • Dentin Hypersensitivity

Browse trials for

Keywords

  • Arginine
  • Sonic Toothbrush
  • Dentinal Hypersensitivity
  • Schiff Cold Air Sensitivity Scale
03

In context

Dentin Sensitivity

289 studies on the registry are indexed under Dentin Sensitivity; 45 are open to participants now.

This study's enrollment of 80 is above the median of 60 across 280 interventional studies indexed under Dentin Sensitivity.

Browse Dentin Sensitivity studies →

Lead sponsor

Colgate Palmolive is the lead sponsor of 118 studies on the registry; 13 are open to participants now.

Of its 35 completed or terminated interventional studies of FDA-regulated products, 2 (6%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
  • 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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
80 participants (actual)

Study arms

  • Experimental
    Test Group (Sonic Toothbrush + 8% Arginine Toothpaste)

    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.

    Drug: 8.0% Arginine Dentifrice · Device: Electric Sonic Toothbrush

  • Active comparator
    Positive Control Group (Manual Toothbrush + 8% Arginine Toothpaste)

    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.

    Drug: 8.0% Arginine Dentifrice · Device: Adult Soft Bristle Manual Toothbrush

Interventions

  • Drug8.0% Arginine Dentifrice

    Commercial fluoride toothpaste containing 8.0% arginine and calcium carbonate.

  • DeviceElectric Sonic Toothbrush

    Commercially available electric sonic toothbrush.

  • DeviceAdult Soft Bristle Manual Toothbrush

    Commercially available adult soft bristle manual toothbrush (ADA reference).

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: Baseline, immediately post-brushing, Day 3, and Day 7.

07

Study locations

1 site
  • The Federal University of Rio Grande do Sul
    Porto Alegre, Rio Grande do Sul 90040-060, Brazil
08

References and documents

Individual participant data

Plan to share: No — Individual participant data will not be shared to maintain confidentiality as outlined in the subject consent and privacy terms.

No publications or documents are linked to this record.

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2021 to primary completion in Feb 2022, 2 months.

Of 14 phase 4 interventional studies under Dentin Sensitivity, half reached primary completion within 2 months of starting (the median); a quarter within 2 and three quarters within 15. This study's 2 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 8, 2026
First posted
Oct 13, 2026
StartActual
Dec 6, 2021
Primary completionActual
Feb 14, 2022
CompletionActual
Feb 14, 2022
Last update
Oct 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 13, 2026
Show all 2 updates
  1. Oct 16, 2026
    Minor edits only
    + 1 other change: conditions
  2. Oct 13, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07871786
Lead sponsor
Colgate Palmolive
Responsible party
Sponsor
First posted
Oct 13, 2026
Start date
Dec 6, 2021
Primary completion
Feb 14, 2022
Completion
Feb 14, 2022
Last update
Oct 16, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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