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

November 5, 2019 updated by: Francesca Lo Presti Arellano, Universidad del Desarrollo

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Grupo I
16 patients
Other: DEENSIBILIZING TOOTHPASTE BASED ON NANOCRISTALS OF HYDROXIAPATITA / 5% POTASSIC NITRATE / SODIUM MONOFluORPHOSPHATE 1450 PARTS PER MILLION
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.
Active Comparator: Grupo II
16 patients
Other: 5% POTASSIC NITRATE / SODIUM FLUORIDE 1426 PARTS PER MILLION TOOTHPASTE
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dentinal Hypersensitivity
Time Frame: 3 months
The cold test will be carried out, through the application of TFE tetrafluoroethane.
3 months
Dentinal Hypersensitivity
Time Frame: 3 months
The heat test will be carried out, by applying a hot gutta-percha bar (120-140 ° C)
3 months
Dentinal Hypersensitivity
Time Frame: 3 months
The electrical test will be carried out, through the application of a vitalometer.
3 months
Dentinal Hipersensitivity
Time Frame: 3 months
The evaporative test will be carried out, after relative isolation with the triple syringe of air
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad del Desarrollo

Collaborators

Florencia Pacheco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 10, 2020

Primary Completion (Anticipated)

July 10, 2020

Study Completion (Anticipated)

August 21, 2020

Study Registration Dates

First Submitted

September 26, 2019

First Submitted That Met QC Criteria

November 5, 2019

First Posted (Actual)

November 7, 2019

Study Record Updates

Last Update Posted (Actual)

November 7, 2019

Last Update Submitted That Met QC Criteria

November 5, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1 (Other Identifier: Mobile Health and Wellness Program)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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