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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

Primary Purpose

Hypersensitivity Dentin

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
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
Sponsored by
Universidad del Desarrollo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypersensitivity Dentin

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Grupo I

    Grupo II

    Arm Description

    16 patients

    16 patients

    Outcomes

    Primary Outcome Measures

    Dentinal Hypersensitivity
    The cold test will be carried out, through the application of TFE tetrafluoroethane.
    Dentinal Hypersensitivity
    The heat test will be carried out, by applying a hot gutta-percha bar (120-140 ° C)
    Dentinal Hypersensitivity
    The electrical test will be carried out, through the application of a vitalometer.
    Dentinal Hipersensitivity
    The evaporative test will be carried out, after relative isolation with the triple syringe of air

    Secondary Outcome Measures

    Full Information

    First Posted
    September 26, 2019
    Last Updated
    November 5, 2019
    Sponsor
    Universidad del Desarrollo
    Collaborators
    Florencia Pacheco
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04156152
    Brief 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
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 10, 2020 (Anticipated)
    Primary Completion Date
    July 10, 2020 (Anticipated)
    Study Completion Date
    August 21, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidad del Desarrollo
    Collaborators
    Florencia Pacheco

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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. 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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypersensitivity Dentin

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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
    ParticipantCare Provider
    Masking Description
    The masking will be done by concealing the two main faces of the dentifrice container with a white adhesive and this will be delivered in sealed packages, all of the same color and shape.
    Allocation
    Randomized
    Enrollment
    32 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Grupo I
    Arm Type
    Active Comparator
    Arm Description
    16 patients
    Arm Title
    Grupo II
    Arm Type
    Active Comparator
    Arm Description
    16 patients
    Intervention Type
    Other
    Intervention Name(s)
    DEENSIBILIZING TOOTHPASTE BASED ON NANOCRISTALS OF HYDROXIAPATITA / 5% POTASSIC NITRATE / SODIUM MONOFluORPHOSPHATE 1450 PARTS PER MILLION
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    5% POTASSIC NITRATE / SODIUM FLUORIDE 1426 PARTS PER MILLION TOOTHPASTE
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Dentinal Hypersensitivity
    Description
    The cold test will be carried out, through the application of TFE tetrafluoroethane.
    Time Frame
    3 months
    Title
    Dentinal Hypersensitivity
    Description
    The heat test will be carried out, by applying a hot gutta-percha bar (120-140 ° C)
    Time Frame
    3 months
    Title
    Dentinal Hypersensitivity
    Description
    The electrical test will be carried out, through the application of a vitalometer.
    Time Frame
    3 months
    Title
    Dentinal Hipersensitivity
    Description
    The evaporative test will be carried out, after relative isolation with the triple syringe of air
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Alicia Morales, Dentist
    Phone
    986772919
    Email
    alicia.morales@udd.cl

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    22695872
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    23224064
    Citation
    Splieth 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.
    Results Reference
    background
    PubMed Identifier
    23229241
    Citation
    Uraz 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.
    Results Reference
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    PubMed Identifier
    18051004
    Citation
    Matis 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.
    Results Reference
    background
    PubMed Identifier
    18538913
    Citation
    Gandolfi 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.
    Results Reference
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    PubMed Identifier
    23449905
    Citation
    Cunha-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.
    Results Reference
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    PubMed Identifier
    11042989
    Citation
    Kihn 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.
    Results Reference
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    PubMed Identifier
    17039676
    Citation
    Haywood VB. Treating sensitivity during tooth whitening. Compend Contin Educ Dent. 2005 Sep;26(9 Suppl 3):11-20.
    Results Reference
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    Learn more about this trial

    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

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