Hypersensitivity DentinNCT04156152
Effectiveness of the Use of Desensitizing Dentifrices Based on Nanocrystals of Hydroxyapatite / 5% Potassium Nitrate / 1450ppm Sodium Monofluorophosphate and Potassium Nitrate 5% / 1426ppm Sodium Floride in the Treatment of Dentine Hypersensitivity. Test Randomized Clinical
A study testing DEENSIBILIZING TOOTHPASTE BASED ON NANOCRISTALS OF HYDROXIAPATITA / 5% POTASSIC NITRATE / SODIUM MONOFluORPHOSPHATE 1450 PARTS PER MILLION and 5% POTASSIC NITRATE / SODIUM FLUORIDE 1426 PARTS PER MILLION TOOTHPASTE in people with Hypersensitivity Dentin, run by Universidad del Desarrollo.
Trial summary
Background: Currently, periodontal treatment, both surgical and non-surgical, leaves sequelae in the vast majority of patients, dentine hypersensitivity (HSD) is one of the most important. For this reason, it is necessary to correctly diagnose this condition, to achieve a correct treatment of it. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypersensitivity Dentin
- What is being tested?
- DEENSIBILIZING TOOTHPASTE BASED ON NANOCRISTALS OF HYDROXIAPATITA / 5% POTASSIC NITRATE / SODIUM MONOFluORPHOSPHATE 1450 PARTS PER MILLION and 5% POTASSIC NITRATE / SODIUM FLUORIDE 1426 PARTS PER MILLION TOOTHPASTE
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 10 Apr 2020to 21 Aug 2020
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
The inclusion criteria that will be used for patient eligibility will be: Patients between 18 and 80 years old, HSD in at least two teeth (incisors, premolars, canines) VAS ≥4 and absence of pathologies that contraindicate participation in the study.
The exclusion criteria that will be addressed will be: Teeth with extensive or defective fillings, tooth decay and pulpitis, dental crack, unit fixed prosthesis and plural fixed prosthesis, pregnant patients, regular treatment with anti-inflammatories, allergy to any of the components of the study and / or recent dentin hypersensitivity treatment.
Trial locations and contacts
No sites are listed yet.
About this study
Background: Currently, periodontal treatment, both surgical and non-surgical, leaves sequelae in the vast majority of patients, dentine hypersensitivity (HSD) is one of the most important. For this reason, it is necessary to correctly diagnose this condition, to achieve a correct treatment of it. HSD is a condition frequently, which has been described as acute, provoked pain, which is not attributable to any other dental pathology. Its current prevalence is unknown, but it occurs in most patients after their periodontal treatment, and also in healthy patients.
Course objective: To compare the clinical efficacy in reducing dentinal hypersensitivity in patients treated with dentifrices based on hydroxyapatite / 5% potassium nitrate / sodium monofluorophosphate 1450ppm and 5% potassium nitrate / 1426ppm sodium fluoride, during a period of evaluation of 8 weeks Materials and methods: A randomized clinical trial will be conducted. Inclusion criteria will be: patients ≥ 18 years, dentinal hypersensitivity in at least one tooth (incisors, canines, premolars) of analogous visual scale ≥4, healthy patients and patients with pathologies, controlled, absence of pathologies that contraindicate participation in the study. Exclusion criteria will include: teeth with extensive or defective fillings, tooth decay and pulpitis, dental crack, unit fixed prosthesis and plural fixed prosthesis, pregnant patients, regular anti-inflammatory treatment, allergy to any of the components of the study, hypersensitivity treatment Recent dentistry Patients will be assigned to two groups. The experimental group (n = 16) will be delivered with hydroxyapatite nanocrystals (VITIS® sensitive) and the control group (n = 16) will be given a paste with 5% potassium nitrate (Sensodyne True White), and after performing an instruction for use on the first visit, four subsequent visits will be made at 2, 4, 6 and 8 weeks after the initial visit. At each visit the hard and soft tissue exam will be performed; and also cold, heat, evaporative and electrical tests will be carried out on the teeth that will be included in the study. The tests will be performed by two previously calibrated researchers, and then the results will be entered into a computer program to perform the effectiveness calculations.
Read more
Expected results: The results of the present study would demonstrate that there is a general decrease in dentinal hypersensitivity in both groups, during the 8-week study period, presenting a significantly greater improvement in dentin hypersensitivity in either of the two control groups.
Keywords: Dentine hypersensitivity, desensitizing paste, hydroxyapatite, potassium nitrate.
Read the detailed description
Currently, periodontal treatment, both surgical and non-surgical, leaves sequelae in the vast majority of patients. The loss of clinical insertion level could be an early indicator or a possible risk factor for dentine hypersensitivity (HSD) (15). Therefore, it is necessary to correctly diagnose this condition, to achieve a correct treatment of it, which can be performed both in the clinic and at home.
HSD is a condition frequently present in individuals, leading them to seek help from a dentist. It has been described as an acute, provoked pain, which is not attributable to any other dental pathology. Its current prevalence is unknown, but it occurs in most patients after their periodontal treatment, and also in healthy patients. (12) To determine the diagnosis and treatment of HSD, it is necessary to deepen the history, the assessment of the patient's pain through a self-assessment system such as the visual analogue scale (VAS), the differentiation between other pathologies using different tools and clinical interpretation, since that the ongoing processes that determine and maintain the opening and permeability of dentinal tubules are still under discussion. Multiple therapeutic modalities are used to manage HSD according to the intensity of pain and patient education, such as the use of remineralizing, desensitizing, blocking, analgesic dentifrices to restorative dentistry therapies, mucogingival surgeries, among others (14).
The research question of this study is: Is the application of a toothpaste based on hydroxyapatite / 5% potassium nitrate / sodium monofluorophosphate 1450ppm nano-crystals more effective compared to the application of a 5% potassium nitrate / fluoride toothpaste Sodium 1426ppm in the treatment of HSD? The general objective is to compare the clinical efficacy in reducing HSD in patients treated with dentifrices based on nano crystals of hydroxyapatite / 5% potassium nitrate / sodium monofluorophosphate 1450ppm and potassium nitrate 5% / sodium fluoride 1426ppm, during an evaluation period 8 weeks The importance of this study lies in the lack of information and quality studies that really assess the effectiveness of the various types of desensitizing toothpastes, so as to be clear about the most effective dentifrices and direct the dentist in the treatment of HSD
- Conditions
- Hypersensitivity Dentin
- Being tested
- DEENSIBILIZING TOOTHPASTE BASED ON NANOCRISTALS OF HYDROXIAPATITA / 5% POTASSIC NITRATE / SODIUM MONOFluORPHOSPHATE 1450 PARTS PER MILLION, 5% POTASSIC NITRATE / SODIUM FLUORIDE 1426 PARTS PER MILLION TOOTHPASTE
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DEENSIBILIZING TOOTHPASTE BASED ON NANOCRISTALS OF HYDROXIAPATITA / 5% POTASSIC NITRATE / SODIUM MONOFluORPHOSPHATE 1450 PARTS PER MILLIONOther
The toothpastes will be delivered by the researchers and will be applied with a manual toothbrush, with soft bristles and straight handle, by the patient.The 2nd, 3rd, 4th session (2nd, 4th, 6th week of follow-up) will be the application of tests and reinforcement of oral hygiene instruction. In the 5th session (8th week of follow-up) the pastes will be requested to verify compliance.
5% POTASSIC NITRATE / SODIUM FLUORIDE 1426 PARTS PER MILLION TOOTHPASTEOther
The toothpastes will be delivered by the researchers and will be applied with a manual toothbrush, with soft bristles and straight handle, by the patient.The 2nd, 3rd, 4th session (2nd, 4th, 6th week of follow-up) will be the application of tests and reinforcement of oral hygiene instruction. In the 5th session (8th week of follow-up) the pastes will be requested to verify compliance.
| Study group | Role | What they receive |
|---|---|---|
| Grupo I | Active comparator | 16 patients Receives: Other: DEENSIBILIZING TOOTHPASTE BASED ON NANOCRISTALS OF HYDROXIAPATITA / 5% POTASSIC NITRATE / SODIUM MONOFluORPHOSPHATE 1450 PARTS PER MILLION |
| Grupo II | Active comparator | 16 patients Receives: Other: 5% POTASSIC NITRATE / SODIUM FLUORIDE 1426 PARTS PER MILLION TOOTHPASTE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dentinal Hypersensitivity
The cold test will be carried out, through the application of TFE tetrafluoroethane.
Measured: 3 months
Dentinal Hypersensitivity
The heat test will be carried out, by applying a hot gutta-percha bar (120-140 ° C)
Measured: 3 months
Dentinal Hypersensitivity
The electrical test will be carried out, through the application of a vitalometer.
Measured: 3 months
Dentinal Hipersensitivity
The evaporative test will be carried out, after relative isolation with the triple syringe of air
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2019
- Study start10 Apr 2020 (estimated)
- Primary completion10 Jul 2020 (estimated)
- Study completion21 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Hypersensitivity DentinStudies 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
- Parallel groups
- Model description
- A randomized clinical trial will be conducted to compare the clinical efficacy in reducing dentinal hypersensitivity in patients treated with dentifrices based on hydroxyapatite / 5% potassium nitrate / sodium monofluorophosphate 1450 ppm and 5% potassium nitrate / 1426ppm sodium fluoride, during an evaluation period of 8 weeks.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad del Desarrollo
- Sponsor type
- University, hospital or other
- Collaborators
- Florencia Pacheco
- Responsible party
- Principal investigator, Francesca Lo Presti Arellano, Universidad del Desarrollo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04156152
- Sponsor's protocol ID
- 1
- Status last verified
- Nov 2019
- First submitted
- 26 Sep 2019
- Last updated
- 7 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Langenbach F, Naujoks C, Smeets R, Berr K, Depprich R, Kubler N, Handschel J. Scaffold-free microtissues: differences from monolayer cultures and their potential in bone tissue engineering. Clin Oral Investig. 2013 Jan;17(1):9-17. doi: 10.1007/s00784-012-0763-8. Epub 2012 Jun 14.
PubMed 22695872Splieth CH, Tachou A. Epidemiology of dentin hypersensitivity. Clin Oral Investig. 2013 Mar;17 Suppl 1(Suppl 1):S3-8. doi: 10.1007/s00784-012-0889-8. Epub 2012 Dec 7.
PubMed 23224064Uraz A, Erol-Simsek O, Pehlivan S, Suludere Z, Bal B. The efficacy of 8% Arginine-CaCO(3) applications on dentine hypersensitivity following periodontal therapy: a clinical and scanning electron microscopic study. Med Oral Patol Oral Cir Bucal. 2013 Mar 1;18(2):e298-305. doi: 10.4317/medoral.17990.
PubMed 23229241Matis BA, Cochran MA, Eckert GJ, Matis JI. In vivo study of two carbamide peroxide gels with different desensitizing agents. Oper Dent. 2007 Nov-Dec;32(6):549-55. doi: 10.2341/07-10.
PubMed 18051004Gandolfi MG, Silvia F, H PD, Gasparotto G, Carlo P. Calcium silicate coating derived from Portland cement as treatment for hypersensitive dentine. J Dent. 2008 Aug;36(8):565-78. doi: 10.1016/j.jdent.2008.03.012. Epub 2008 Jun 6.
PubMed 18538913Cunha-Cruz J, Wataha JC, Heaton LJ, Rothen M, Sobieraj M, Scott J, Berg J; Northwest Practice-based Research Collaborative in Evidence-based DENTistry. The prevalence of dentin hypersensitivity in general dental practices in the northwest United States. J Am Dent Assoc. 2013 Mar;144(3):288-96. doi: 10.14219/jada.archive.2013.0116.
PubMed 23449905Kihn PW, Barnes DM, Romberg E, Peterson K. A clinical evaluation of 10 percent vs. 15 percent carbamide peroxide tooth-whitening agents. J Am Dent Assoc. 2000 Oct;131(10):1478-84. doi: 10.14219/jada.archive.2000.0061.
PubMed 11042989Haywood VB. Treating sensitivity during tooth whitening. Compend Contin Educ Dent. 2005 Sep;26(9 Suppl 3):11-20.
PubMed 17039676
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Use of Desensitizing Dentifrices Based on Nanocrystals of Hydroxyapatite / 5% Potassium Nitrate / 1450ppm Sodium Monofluorophosphate and Potassium Nitrate 5% / 1426ppm Sodium Floride in the Treatment of Dentine Hypersensitivity. Test Randomized Clinical
- ClinicalTrials.gov ID
- NCT04156152
- Acronym / sponsor ID
- 1
- Conditions
- Hypersensitivity Dentin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Universidad del DesarrolloUniversity, hospital or other
- Collaborators
- Florencia Pacheco
- Study start
- 10 Apr 2020 (estimated)
- Primary completion
- 10 Jul 2020 (estimated)
- Study completion
- 21 Aug 2020 (estimated)
- First posted
- 7 Nov 2019 (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.
Background: Currently, periodontal treatment, both surgical and non-surgical, leaves sequelae in the vast majority of patients, dentine hypersensitivity (HSD) is one of the most important. For this reason, it is necessary to correctly diagnose this condition, to achieve a correct treatment of it. HSD is a condition frequently, which has been described as acute, provoked pain, which is not attributable to any other dental pathology. Its current prevalence is unknown, but it occurs in most patients after their periodontal treatment, and also in healthy patients.
Course objective: To compare the clinical efficacy in reducing dentinal hypersensitivity in patients treated with dentifrices based on hydroxyapatite / 5% potassium nitrate / sodium monofluorophosphate 1450ppm and 5% potassium nitrate / 1426ppm sodium fluoride, during a period of evaluation of 8 weeks Materials and methods: A randomized clinical trial will be conducted. Inclusion criteria will be: patients ≥ 18 years, dentinal hypersensitivity in at least one tooth (incisors, canines, premolars) of analogous visual scale ≥4, healthy patients and patients with pathologies, controlled, absence of pathologies that contraindicate participation in the study. Exclusion criteria will include: teeth with extensive or defective fillings, tooth decay and pulpitis, dental crack, unit fixed prosthesis and plural fixed prosthesis, pregnant patients, regular anti-inflammatory treatment, allergy to any of the components of the study, hypersensitivity treatment Recent dentistry Patients will be assigned to two groups. The experimental group (n = 16) will be delivered with hydroxyapatite nanocrystals (VITIS® sensitive) and the control group (n = 16) will be given a paste with 5% potassium nitrate (Sensodyne True White), and after performing an instruction for use on the first visit, four subsequent visits will be made at 2, 4, 6 and 8 weeks after the initial visit. At each visit the hard and soft tissue exam will be performed; and also cold, heat, evaporative and electrical tests will be carried out on the teeth that will be included in the study. The tests will be performed by two previously calibrated researchers, and then the results will be entered into a computer program to perform the effectiveness calculations.
Expected results: The results of the present study would demonstrate that there is a general decrease in dentinal hypersensitivity in both groups, during the 8-week study period, presenting a significantly greater improvement in dentin hypersensitivity in either of the two control groups.
Keywords: Dentine hypersensitivity, desensitizing paste, hydroxyapatite, potassium nitrate.
Detailed description
Currently, periodontal treatment, both surgical and non-surgical, leaves sequelae in the vast majority of patients. The loss of clinical insertion level could be an early indicator or a possible risk factor for dentine hypersensitivity (HSD) (15). Therefore, it is necessary to correctly diagnose this condition, to achieve a correct treatment of it, which can be performed both in the clinic and at home.
HSD is a condition frequently present in individuals, leading them to seek help from a dentist. It has been described as an acute, provoked pain, which is not attributable to any other dental pathology. Its current prevalence is unknown, but it occurs in most patients after their periodontal treatment, and also in healthy patients. (12) To determine the diagnosis and treatment of HSD, it is necessary to deepen the history, the assessment of the patient's pain through a self-assessment system such as the visual analogue scale (VAS), the differentiation between other pathologies using different tools and clinical interpretation, since that the ongoing processes that determine and maintain the opening and permeability of dentinal tubules are still under discussion. Multiple therapeutic modalities are used to manage HSD according to the intensity of pain and patient education, such as the use of remineralizing, desensitizing, blocking, analgesic dentifrices to restorative dentistry therapies, mucogingival surgeries, among others (14).
The research question of this study is: Is the application of a toothpaste based on hydroxyapatite / 5% potassium nitrate / sodium monofluorophosphate 1450ppm nano-crystals more effective compared to the application of a 5% potassium nitrate / fluoride toothpaste Sodium 1426ppm in the treatment of HSD? The general objective is to compare the clinical efficacy in reducing HSD in patients treated with dentifrices based on nano crystals of hydroxyapatite / 5% potassium nitrate / sodium monofluorophosphate 1450ppm and potassium nitrate 5% / sodium fluoride 1426ppm, during an evaluation period 8 weeks The importance of this study lies in the lack of information and quality studies that really assess the effectiveness of the various types of desensitizing toothpastes, so as to be clear about the most effective dentifrices and direct the dentist in the treatment of HSD
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- A randomized clinical trial will be conducted to compare the clinical efficacy in reducing dentinal hypersensitivity in patients treated with dentifrices based on hydroxyapatite / 5% potassium nitrate / sodium monofluorophosphate 1450 ppm and 5% potassium nitrate / 1426ppm sodium fluoride, during an evaluation period of 8 weeks.
| Arm | Type | Receives |
|---|---|---|
| Grupo I | Active comparator | Other: DEENSIBILIZING TOOTHPASTE BASED ON NANOCRISTALS OF HYDROXIAPATITA / 5% POTASSIC NITRATE / SODIUM MONOFluORPHOSPHATE 1450 PARTS PER MILLION16 patients |
| Grupo II | Active comparator | Other: 5% POTASSIC NITRATE / SODIUM FLUORIDE 1426 PARTS PER MILLION TOOTHPASTE16 patients |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| DEENSIBILIZING TOOTHPASTE BASED ON NANOCRISTALS OF HYDROXIAPATITA / 5% POTASSIC NITRATE / SODIUM MONOFluORPHOSPHATE 1450 PARTS PER MILLIONThe toothpastes will be delivered by the researchers and will be applied with a manual toothbrush, with soft bristles and straight handle, by the patient.The 2nd, 3rd, 4th session (2nd, 4th, 6th week of follow-up) will be the application of tests and reinforcement of oral hygiene instruction. In the 5th session (8th week of follow-up) the pastes will be requested to verify compliance. | Other | Grupo I |
| 5% POTASSIC NITRATE / SODIUM FLUORIDE 1426 PARTS PER MILLION TOOTHPASTEThe toothpastes will be delivered by the researchers and will be applied with a manual toothbrush, with soft bristles and straight handle, by the patient.The 2nd, 3rd, 4th session (2nd, 4th, 6th week of follow-up) will be the application of tests and reinforcement of oral hygiene instruction. In the 5th session (8th week of follow-up) the pastes will be requested to verify compliance. | Other | Grupo II |
Primary outcome
Dentinal Hypersensitivity
Time frame: 3 months
The cold test will be carried out, through the application of TFE tetrafluoroethane.
Dentinal Hypersensitivity
Time frame: 3 months
The heat test will be carried out, by applying a hot gutta-percha bar (120-140 ° C)
Dentinal Hypersensitivity
Time frame: 3 months
The electrical test will be carried out, through the application of a vitalometer.
Dentinal Hipersensitivity
Time frame: 3 months
The evaporative test will be carried out, after relative isolation with the triple syringe of air
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2019.
- Background: PubMed 22695872Langenbach F, Naujoks C, Smeets R, Berr K, Depprich R, Kubler N, Handschel J. Scaffold-free microtissues: differences from monolayer cultures and their potential in bone tissue engineering. Clin Oral Investig. 2013 Jan;17(1):9-17. doi: 10.1007/s00784-012-0763-8. Epub 2012 Jun 14.
- Background: PubMed 23224064Splieth CH, Tachou A. Epidemiology of dentin hypersensitivity. Clin Oral Investig. 2013 Mar;17 Suppl 1(Suppl 1):S3-8. doi: 10.1007/s00784-012-0889-8. Epub 2012 Dec 7.
- Background: PubMed 23229241Uraz A, Erol-Simsek O, Pehlivan S, Suludere Z, Bal B. The efficacy of 8% Arginine-CaCO(3) applications on dentine hypersensitivity following periodontal therapy: a clinical and scanning electron microscopic study. Med Oral Patol Oral Cir Bucal. 2013 Mar 1;18(2):e298-305. doi: 10.4317/medoral.17990.
- Background: PubMed 18051004Matis BA, Cochran MA, Eckert GJ, Matis JI. In vivo study of two carbamide peroxide gels with different desensitizing agents. Oper Dent. 2007 Nov-Dec;32(6):549-55. doi: 10.2341/07-10.
- Background: PubMed 18538913Gandolfi MG, Silvia F, H PD, Gasparotto G, Carlo P. Calcium silicate coating derived from Portland cement as treatment for hypersensitive dentine. J Dent. 2008 Aug;36(8):565-78. doi: 10.1016/j.jdent.2008.03.012. Epub 2008 Jun 6.
- Background: PubMed 23449905Cunha-Cruz J, Wataha JC, Heaton LJ, Rothen M, Sobieraj M, Scott J, Berg J; Northwest Practice-based Research Collaborative in Evidence-based DENTistry. The prevalence of dentin hypersensitivity in general dental practices in the northwest United States. J Am Dent Assoc. 2013 Mar;144(3):288-96. doi: 10.14219/jada.archive.2013.0116.
- Background: PubMed 11042989Kihn PW, Barnes DM, Romberg E, Peterson K. A clinical evaluation of 10 percent vs. 15 percent carbamide peroxide tooth-whitening agents. J Am Dent Assoc. 2000 Oct;131(10):1478-84. doi: 10.14219/jada.archive.2000.0061.
- Background: PubMed 17039676Haywood VB. Treating sensitivity during tooth whitening. Compend Contin Educ Dent. 2005 Sep;26(9 Suppl 3):11-20.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing DEENSIBILIZING TOOTHPASTE BASED ON NANOCRISTALS OF HYDROXIAPATITA / 5% POTASSIC NITRATE / SODIUM MONOFluORPHOSPHATE 1450 PARTS PER MILLION and 5% POTASSIC NITRATE / SODIUM FLUORIDE 1426 PARTS PER MILLION TOOTHPASTE in people with Hypersensitivity Dentin, run by Universidad del Desarrollo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 7 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
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.
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 Alicia Morales, Dentist (986772919, alicia.morales@udd.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dentinal Hypersensitivity (time frame: 3 months). The study lists 4 primary outcomes in all. 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 NCT04156152, which also lists 8 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 7 Nov 2019.