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

NCT04156152 | Unknown

• 1 other identifier: 1
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hypersensitivity Dentin

Outcome Measures

Primary Outcomes (4)

• Dentinal Hypersensitivity

  The cold test will be carried out, through the application of TFE tetrafluoroethane.

  3 months

• Dentinal Hypersensitivity

  The heat test will be carried out, by applying a hot gutta-percha bar (120-140 ° C)

  3 months

• Dentinal Hypersensitivity

  The electrical test will be carried out, through the application of a vitalometer.

  3 months

• Dentinal Hipersensitivity

  The evaporative test will be carried out, after relative isolation with the triple syringe of air

  3 months

Study Arms (2)

Grupo I

ACTIVE COMPARATOR

16 patients

Other: DEENSIBILIZING TOOTHPASTE BASED ON NANOCRISTALS OF HYDROXIAPATITA / 5% POTASSIC NITRATE / SODIUM MONOFluORPHOSPHATE 1450 PARTS PER MILLION

Grupo II

ACTIVE COMPARATOR

16 patients

Other: 5% POTASSIC NITRATE / SODIUM FLUORIDE 1426 PARTS PER MILLION TOOTHPASTE

Interventions

DEENSIBILIZING TOOTHPASTE BASED ON NANOCRISTALS OF HYDROXIAPATITA / 5% POTASSIC NITRATE / SODIUM MONOFluORPHOSPHATE 1450 PARTS PER MILLION OTHER

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.

Grupo I

5% POTASSIC NITRATE / SODIUM FLUORIDE 1426 PARTS PER MILLION TOOTHPASTE OTHER

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.

Grupo II

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Universidad del Desarrollo: lead
• Florencia Pacheco: collaborator

Related Publications (8)

• 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.

  PMID: 22695872 BACKGROUND

• 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.

  PMID: 23224064 BACKGROUND

• 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.

  PMID: 23229241 BACKGROUND

• 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.

  PMID: 18051004 BACKGROUND

• 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.

  PMID: 18538913 BACKGROUND

• 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.

  PMID: 23449905 BACKGROUND

• 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.

  PMID: 11042989 BACKGROUND

• Haywood VB. Treating sensitivity during tooth whitening. Compend Contin Educ Dent. 2005 Sep;26(9 Suppl 3):11-20.

  PMID: 17039676 BACKGROUND

MeSH Terms

Conditions

Dentin Sensitivity

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Central Study Contacts

Alicia Morales, Dentist

CONTACT

986772919; alicia.morales@udd.cl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Alumn Periodonthics UDD

Model Details: 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.

Study Record Dates

• First Submitted: September 26, 2019
• First Posted: November 7, 2019
• Study Start: April 10, 2020
• Primary Completion: July 10, 2020
• Study Completion: August 21, 2020
• Last Updated: November 7, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share