Dentin SensitivityPhase 3NCT02829879
Effectiveness of Arginin and Potassium Nitrate Dentifrices in Dentin Hypersensitivity Therapy
A Phase 3 study testing 8% arginine/1450ppm sodium monofluorophosphate dentifrice and 5% potassium nitrate/2500ppm sodium fluoride dentifrice in people with Dentin Sensitivity, run by University of Chile at 1 site in Chile.
Trial summary
Introduction: Dentin hypersensitivity (DH) could be defined as a brief and sharp pain in response to thermical, chemical, tactile and osmotic stimuli, which cannot be attributed to any dental condition or pathology. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Dentin Sensitivity
- What is being tested?
- 8% arginine/1450ppm sodium monofluorophosphate dentifrice and 5% potassium nitrate/2500ppm sodium fluoride dentifrice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChile
- Study dates
- Dec 2015to Sep 2016
- Phase
- Phase 3
- 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
- Age between 18 and 70 years
- Dentin sensitivity in at least 2 teeth (incisors, cuspids and/or bicuspids) with a VAS score ≥4
- Good general health
Who cannot join
- Defective or extensive restorations, deep dental caries, pulpitis, chipped teeth,
- Bridgework, dentures or crowned teeth that could interfere with the evaluation of hypersensitivity
- Pregnancy or lactation
- Ongoing treatment with anti-inflammatory or sedative drugs
- Systemic conditions that are etiologic or predisposing to dentine hypersensitivity, like chronic acid regurgitation
- Ongoing periodontal therapy or periodontal surgery in the preceding 3 months
- Allergic responses to the dentifrices
- Hypersensitivity treatment in the preceding 3 months
Trial locations and contacts
1 site in 1 country.
Chile1 site, 1 recruiting
- Recruiting
Faculty of Dentistry, University of Chile
Santiago, Santiago Metropolitan
Patricia Hernández-Ríos, Professor, +56229781839, phernandezrios@gmail.com
About this study
Official title: Comparison of the Clinical Effectiveness of 8% Arginine/1450 Ppm Sodium Monofluorophosphate Versus 5% Potassium Nitrate/2500 Ppm Sodium Fluoride in Dentin Hypersensitivity Therapy: A Randomized Controlled Clinical Trial
Introduction: Dentin hypersensitivity (DH) could be defined as a brief and sharp pain in response to thermical, chemical, tactile and osmotic stimuli, which cannot be attributed to any dental condition or pathology. Multiple therapies for the treatment of DH have been studied, including equivocal evidence about the efficacy of potassium nitrate salts and recent investigations a promising new 8% Arginin dentifrice.
Aim: The aim of this study is to compare the clinical effectiveness of 8% arginine/1450ppm sodium monofluorophosphate (D1) and 5% potassium nitrate/2500ppm sodium fluoride (D2) dentifrices in the treatment of dentin hypersensitivity.
Methods: Parallel-design, double-masked, randomized controlled clinical trial. Fifty healthy volunteers aged 18 to 70 years who attend at the Faculty of Dentistry , University of Chile, with DH and a visual analog scale (VAS) score ≥4 at least in two anterior and/or premolar teeth, will be selected and randomized into two treatment groups: T1 (n=25): 8% arginine/1450 ppm sodium monofluorophosphate dentifrice (D1); and T2 (n=25): 5% potassium nitrate/2500 ppm sodium fluoride dentifrice (D2). Environmental, dietary and oral hygiene habits will be recorded in a clinical chart, while O´Leary plaque index and dentin hypersensitivity (DH) measurements will be clinically assessed, at baseline, 4 and 8 weeks. DH will be evaluated through the mean VAS value in response to evaporative and thermal stimuli at baseline, 4 and 8 week follow-up. The data will be analysed through Stata® V11 program.
- Conditions
- Dentin Sensitivity
- Being tested
- 8% arginine/1450ppm sodium monofluorophosphate dentifrice, 5% potassium nitrate/2500ppm sodium fluoride dentifrice
- Keywords
- Dentin Sensitivity, Arginin, Potassium Nitrate, Dentifrice, RCT
- 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% arginine/1450ppm sodium monofluorophosphate dentifriceDrug
5% potassium nitrate/2500ppm sodium fluoride dentifriceDrug
| Study group | Role | What they receive |
|---|---|---|
| arginine | Experimental | 25 volunteers with dentin sensitivity Receives: Drug: 8% arginine/1450ppm sodium monofluorophosphate dentifrice |
| potassium nitrate | Active comparator | 25 volunteers with dentin sensitivity Receives: Drug: 5% potassium nitrate/2500ppm sodium fluoride dentifrice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in mean VAS score per subject
Measured: Baseline, 4 and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2016 (estimated)
- Study startDec 2015
- Primary completionSep 2016 (estimated)
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.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patricia Hernández-Ríos, University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02829879
- Sponsor's protocol ID
- FIOUCh 13-103
- Status last verified
- Jul 2016
- First submitted
- 8 Jul 2016
- Last updated
- 12 Jul 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Clinical Effectiveness of 8% Arginine/1450 Ppm Sodium Monofluorophosphate Versus 5% Potassium Nitrate/2500 Ppm Sodium Fluoride in Dentin Hypersensitivity Therapy: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT02829879
- Acronym / sponsor ID
- FIOUCh 13-103
- Conditions
- Dentin Sensitivity
- Keywords
- Dentin Sensitivity, Arginin, Potassium Nitrate, Dentifrice, RCT
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Sep 2016 (estimated)
- First posted
- 12 Jul 2016 (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.
Introduction: Dentin hypersensitivity (DH) could be defined as a brief and sharp pain in response to thermical, chemical, tactile and osmotic stimuli, which cannot be attributed to any dental condition or pathology. Multiple therapies for the treatment of DH have been studied, including equivocal evidence about the efficacy of potassium nitrate salts and recent investigations a promising new 8% Arginin dentifrice.
Aim: The aim of this study is to compare the clinical effectiveness of 8% arginine/1450ppm sodium monofluorophosphate (D1) and 5% potassium nitrate/2500ppm sodium fluoride (D2) dentifrices in the treatment of dentin hypersensitivity.
Methods: Parallel-design, double-masked, randomized controlled clinical trial. Fifty healthy volunteers aged 18 to 70 years who attend at the Faculty of Dentistry , University of Chile, with DH and a visual analog scale (VAS) score ≥4 at least in two anterior and/or premolar teeth, will be selected and randomized into two treatment groups: T1 (n=25): 8% arginine/1450 ppm sodium monofluorophosphate dentifrice (D1); and T2 (n=25): 5% potassium nitrate/2500 ppm sodium fluoride dentifrice (D2). Environmental, dietary and oral hygiene habits will be recorded in a clinical chart, while O´Leary plaque index and dentin hypersensitivity (DH) measurements will be clinically assessed, at baseline, 4 and 8 weeks. DH will be evaluated through the mean VAS value in response to evaporative and thermal stimuli at baseline, 4 and 8 week follow-up. The data will be analysed through Stata® V11 program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| arginine | Experimental | Drug: 8% arginine/1450ppm sodium monofluorophosphate dentifrice25 volunteers with dentin sensitivity |
| potassium nitrate | Active comparator | Drug: 5% potassium nitrate/2500ppm sodium fluoride dentifrice25 volunteers with dentin sensitivity |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 18 and 70 years
- Dentin sensitivity in at least 2 teeth (incisors, cuspids and/or bicuspids) with a VAS score ≥4
- Good general health
Key exclusion criteria (8 listed)
- Defective or extensive restorations, deep dental caries, pulpitis, chipped teeth,
- Bridgework, dentures or crowned teeth that could interfere with the evaluation of hypersensitivity
- Pregnancy or lactation
- Ongoing treatment with anti-inflammatory or sedative drugs
- Systemic conditions that are etiologic or predisposing to dentine hypersensitivity, like chronic acid regurgitation
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% arginine/1450ppm sodium monofluorophosphate dentifrice | Drug | arginine |
| 5% potassium nitrate/2500ppm sodium fluoride dentifrice | Drug | potassium nitrate |
Primary outcome
Differences in mean VAS score per subject
Time frame: Baseline, 4 and 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2016.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 8% arginine/1450ppm sodium monofluorophosphate dentifrice and 5% potassium nitrate/2500ppm sodium fluoride dentifrice in people with Dentin Sensitivity, run by University of Chile at 1 site in Chile.
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 8 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: status not confirmed, as of the sponsor's last update on 12 Jul 2016. 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 Chile. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patricia Hernández-Ríos, Professor (+56229781839, phernandezrios@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in mean VAS score per subject (time frame: Baseline, 4 and 8 weeks). 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 12 Jul 2016.