Dentine HypersensitivityNCT02018783
Single Application of Desensitizing Pastes as Dentin Sensitivity Treatment
A study testing Colgate, Sensodyne and Nano P in people with Dentine Hypersensitivity, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
The aim of this study was to evaluate the efficacy of three desensitizing toothpastes for immediate and intermediate-term relief of CDH, when compared with a control toothpaste. One hundred and thirty-eight hypersensitive teeth were diagnosed and randomized into four groups according to the therapeutic agent of each… Read more about this study
- Who is it for?
- Ages 22 to 48 yearsHealthy volunteers can take part
- Conditions the study is for
- Dentine Hypersensitivity
- What is being tested?
- Colgate, Sensodyne and Nano P
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 138 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2013to Aug 2013
- Phase
- Interventional
- 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 22 to 48 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- subjects 18 years or older
- in good general and oral health; have complaint of CDH in teeth distributed in all 4 quadrants
- not making use of desensitizing agents
- not having undergone periodontal treatment over the past 3 months
- respond to evaporative stimulus with a score ≥ 1.5 cm on VAS
Who cannot join
- patients who presented restorations and caries near the exposed dentin of the hypersensitive teeth
- who made frequent use of painkillers, anti-inflammatory and antidepressants drugs
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Periodontics Clinic, Department of Dentistry
Diamantina, Minas Gerais, 39100000
About this study
Official title: Clinical Evaluation of the Effectiveness of Immediate Relief Obtained With Desensitizing Creams - A Controlled, Randomized, Triple Masked, Split-Mouth Clinical Trial
The aim of this study was to evaluate the efficacy of three desensitizing toothpastes for immediate and intermediate-term relief of CDH, when compared with a control toothpaste. One hundred and thirty-eight hypersensitive teeth were diagnosed and randomized into four groups according to the therapeutic agent of each desensitizing cream tested: 1) strontium acetate and calcium carbonate, 2) calcium carbonate and arginine 8%, 3) calcium phosphate nanoparticles and 4) a control toothpaste. The desensitizing creams were applied according to the manufacturer's instructions. Cervical dentin hypersensitivity was assessed at baseline, immediately, 24 hours and 30 days after the treatment. Cold and evaporative tests were used to assess the sensitivity level.
- Conditions
- Dentine Hypersensitivity
- Being tested
- Colgate, Sensodyne, Nano P, Cocorico
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColgateProcedure or surgery
Slow-speed handpiece with a Robson brush for 3 seconds by repeating the procedure
SensodyneProcedure or surgery
Digital application for 60 seconds.
Nano PProcedure or surgery
Slow-speed handpiece with a Robson brush for 10 seconds
CocoricoProcedure or surgery
Digital application for 60 seconds
| Study group | Role | What they receive |
|---|---|---|
| Sensodyne | Experimental | Digital application for 60 seconds. Receives: Procedure: Sensodyne |
| Colgate | Experimental | Slow-speed handpiece with a Robson brush for 3 seconds by repeating the procedure Receives: Procedure: Colgate |
| Nano P | Experimental | Slow-speed handpiece with a Robson brush for 10 seconds Receives: Procedure: Nano P |
| Cocorico | Placebo comparator | Digital application for 60 seconds Receives: Procedure: Cocorico |
What is being measured
The primary outcome is the main question the study is designed to answer.
cervical dentin hypersensitivity
The cervical dentin hypersensitivity was evaluated by an air blast (evaporative stimulus) for 5 seconds, and by a tetrafluoroethane spray (cold stimulus) for 5 seconds.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2013 (estimated)
- Study startApr 2013
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dentine 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olga Flecha, Federal University of São Paulo
- Investigators
- Olga D Flecha, PhD, Principal investigator, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02018783
- Sponsor's protocol ID
- dessensibilizantes
- Status last verified
- Dec 2013
- First submitted
- 7 Dec 2013
- Last updated
- 23 Dec 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Effectiveness of Immediate Relief Obtained With Desensitizing Creams - A Controlled, Randomized, Triple Masked, Split-Mouth Clinical Trial
- ClinicalTrials.gov ID
- NCT02018783
- Acronym / sponsor ID
- dessensibilizantes
- Conditions
- Dentine Hypersensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 23 Dec 2013 (estimated)
- 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.
The aim of this study was to evaluate the efficacy of three desensitizing toothpastes for immediate and intermediate-term relief of CDH, when compared with a control toothpaste. One hundred and thirty-eight hypersensitive teeth were diagnosed and randomized into four groups according to the therapeutic agent of each desensitizing cream tested: 1) strontium acetate and calcium carbonate, 2) calcium carbonate and arginine 8%, 3) calcium phosphate nanoparticles and 4) a control toothpaste. The desensitizing creams were applied according to the manufacturer's instructions. Cervical dentin hypersensitivity was assessed at baseline, immediately, 24 hours and 30 days after the treatment. Cold and evaporative tests were used to assess the sensitivity level.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sensodyne | Experimental | Procedure: SensodyneDigital application for 60 seconds. |
| Colgate | Experimental | Procedure: ColgateSlow-speed handpiece with a Robson brush for 3 seconds by repeating the procedure |
| Nano P | Experimental | Procedure: Nano PSlow-speed handpiece with a Robson brush for 10 seconds |
| Cocorico | Placebo comparator | Procedure: CocoricoDigital application for 60 seconds |
Who may qualify
- Ages
- 22 to 48 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- subjects 18 years or older
- in good general and oral health; have complaint of CDH in teeth distributed in all 4 quadrants
- not making use of desensitizing agents
- not having undergone periodontal treatment over the past 3 months
- respond to evaporative stimulus with a score ≥ 1.5 cm on VAS
Key exclusion criteria (2 listed)
- patients who presented restorations and caries near the exposed dentin of the hypersensitive teeth
- who made frequent use of painkillers, anti-inflammatory and antidepressants drugs
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 |
|---|---|---|
| ColgateSlow-speed handpiece with a Robson brush for 3 seconds by repeating the procedure | Procedure or surgery | Colgate |
| SensodyneDigital application for 60 seconds. | Procedure or surgery | Sensodyne |
| Nano PSlow-speed handpiece with a Robson brush for 10 seconds | Procedure or surgery | Nano P |
| CocoricoDigital application for 60 seconds | Procedure or surgery | Cocorico |
Primary outcome
cervical dentin hypersensitivity
Time frame: 30 days
The cervical dentin hypersensitivity was evaluated by an air blast (evaporative stimulus) for 5 seconds, and by a tetrafluoroethane spray (cold stimulus) for 5 seconds.
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 23 Dec 2013.
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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.
Olga D Flecha, PhD principal investigator
Federal University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colgate, Sensodyne and Nano P in people with Dentine Hypersensitivity, run by Federal University of São Paulo 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 5 inclusion and 2 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 23 Dec 2013. 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. 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.
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?
cervical dentin hypersensitivity (time frame: 30 days). 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 23 Dec 2013; AzTrials last refreshed its copy on 6 Nov 2026.