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Trial record 48 of 292 for:    Sodium Fluoride OR Duraphat

Different Concentrations of Potassium Nitrate in In-office Tooth Bleaching Sensitivity

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ClinicalTrials.gov Identifier: NCT03323372
Recruitment Status : Completed
First Posted : October 27, 2017
Last Update Posted : October 27, 2017
Sponsor:
Information provided by (Responsible Party):
larissa alves de lima e souza, Universidade Federal do Amazonas

Brief Summary:
The aim of this randomized, double-blind controlled clinical study was to evaluate the absolute risk and intensity of sensitivity to dental bleaching in adults on the application of two different gels based on potassium nitrate and sodium fluoride from a prospective randomized clinical study.

Condition or disease Intervention/treatment Phase
Tooth Sensitivity Drug: 3% potassium nitrate and 0.25% sodium fluoride Drug: 5% potassium nitrate and 2% sodium fluoride Phase 2

Detailed Description:

For this study, 56 volunteers who had an equal allocation rate between the groups (G1-control and G2-experimental) were selected for this study. Both gels act in the same way, the difference between them is the concentration. In both groups, the different desensitizing gels were applied to the vestibular surface of the anterior superior teeth with the aid of a tray, remaining in position according to the time specified by the manufacturers. In the control group, a gel based on 5% potassium nitrate and 2% sodium fluoride was used, while in the experimental group, the gel was based on 3% potassium nitrate and 0.25% sodium fluoride. After removal of the desensitizing gel, both groups were subjected to bleaching with 40% hydrogen peroxide gel for 40 minutes. Patients recorded an occurrence or not of dental sensitivity (SD) in a sensitivity diary for 48 hours. A Verbal Evaluation Scale (VRS) and a Visual Analogue Scale (VAS) were used for pain assessment. The values were organized into two categories: percentage of patients who presented SD at some time of treatment (absolute risk of sensitivity) and SD intensity. To evaluate the color before the first bleaching session, and after 7, 14 and 28 days, two methods were used: objective evaluation using the spectrophotometer and subjective evaluation using two color scales: Vita Classical and Vita Bleachedguide 3D-MASTER. An analysis of the data followed the intent-to-treat protocol and involved all randomly allocated participants. The absolute risk of SD was compared using Fisher's exact test (α = 5%). The Mann-Whitney test was used to compare the intensity of SD.

Student's t test was used to compare the color change. The level of significance adopted in all tests was 5%.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The design of this randomized, double blind, intervention study was structured based on the CONSORT (Consolidated Standards of Reporting Trials) standards.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Different Concentrations of Potassium Nitrate in In-office Tooth Bleaching Sensitivity: a Randomized Clinical Trial
Study Start Date : December 21, 2016
Actual Primary Completion Date : May 5, 2017
Actual Study Completion Date : May 20, 2017


Arm Intervention/treatment
Active Comparator: control group
In group 1 (G1-control), the operator applied a desensitizing gel based on 5% potassium nitrate and 2% sodium fluoride (Desensibilize KF 2% ®, FGM , Joinville, Santa Catarina, Brazil) with the aid of a custom silicone tray, which was made from a model obtained from the patient, with a vacuum plasticizer. A small layer of the gel was placed on the surface of the tray that was in contact with the vestibular face of the upper anterior teeth of the participants. The tray remained in position in the mouth for 10 minutes, according to the manufacturer's specifications.
Drug: 5% potassium nitrate and 2% sodium fluoride
Other Name: Desensibilize KF 2%

Experimental: experimental group
In group 2 (G2-intervention group), the operator applied a desensitizing gel containing 3% potassium nitrate and 0.25% sodium fluoride (Ultra EZ®, Ultradent Products Inc, South Jordan, UT, Estados Unidos) with the help of a tray in which the material is stored on the vestibular surfaces of the upper anterior teeth of the participants. The tray remained in position in the mouth for 15 minutes, according to the manufacturer's specifications.
Drug: 3% potassium nitrate and 0.25% sodium fluoride
Other Name: Ultra EZ




Primary Outcome Measures :
  1. absolute risk of tooth sensibility [ Time Frame: 28 days ]
    Patients recorded the occurrence or not of tooth sensitivity (TS) in a sensitivity diary. Participants were asked to register if they experienced DS during treatment and up to 48 hours after bleaching. The Analogic Visual Scale (AVS) was used to assess pain. Each item was scored 0-10 (0- no pain and 10- pain as bad as can be).


Secondary Outcome Measures :
  1. sensitivity intensity [ Time Frame: 28 days ]
    Patients were asked to record their perception of tooth sensitivity (TS) during the first and second bleaching sessions using the five-point Numeric Rating Scale (0 = none, 1 = mild, 2 = moderate, 3 = considerable, and 4 = severe]. Subjects were asked to record their experience with TS during the treatment, up to 1 h after bleaching, from 1 h to 24 h, and from 24 to 48 h after bleaching. They were also asked to record whether their experienced or not TS during the 30-day period after bleaching. As two bleaching sessions were performed, the highest score obtained in both bleaching sessions was considered for statistical purposes.

  2. effectiveness of tooth whitening - objective [ Time Frame: 28 days ]
    Color was recorded before the bleaching procedure, 7 days and 30 days after the end of the bleaching treatment using an objective method (Easyshade spectrophotometer, Vident, Brea, CA, USA). For each evaluation, three readings were performed using the CIELab system parameters, in which: L * indicates luminosity, a * represents color and saturation on the red-green axis and b * means color and saturation on the yellow-blue axis. Color evaluation was done in a room under artificial lightning conditions without interference from outside light. The color was checked at the middle third of the canine.

  3. effectiveness of tooth whitening - subjective [ Time Frame: 28 days ]
    Color was recorded before the bleaching procedure, 7 days and 30 days after the end of the bleaching treatment using a subjective (value-oriented shade guide Vita Classic). For subjective evaluation, the 16 color guides of the Vita Classical scale (Vita Zahnfabrik®, Bad Säckingen, Germany) were organized from the highest value (B1) to the lowest value (C4). Although the scale is not linear, it was organized by value representing a ranking for analysis purposes. Color evaluation was done in a room under artificial lightning conditions without interference from outside light. The color was checked at the middle third of the canine.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients aged 18 years and older, of both sexes, who had to present at least six upper anterior teeth free of caries and restorations on the vestibular face, and at least one central or canine incisor showing coloration A2 or darker, evaluated in comparison to a visual value-oriented color scale of the teeth (Vita Classical®, Vita-Zahnfabrik- Germany).

Prior to the interventions, the signing of each participant's free and informed consent form (Appendix I) was obtained after due explanations about the nature of the study and the possible risks of the proposed treatments.

Exclusion Criteria:

  • The individuals excluded from the study were: users of fixed orthodontic appliances, patients with periodontal disease, pregnant or lactating, with severe intrinsic stains on the teeth (spots on the use of tetracycline, fluorosis and depolluted teeth), consuming any Anti-inflammatory and anti-oxidant drugs, using desensitizing dentifrice and participants with previous history of SD or any associated pathology (bruxism, gingival recession, non-carious lesion with dentin exposure).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03323372


Sponsors and Collaborators
Universidade Federal do Amazonas
Investigators
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Study Chair: Leandro M Martins, doctorate amazon federal university

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Responsible Party: larissa alves de lima e souza, master student, Universidade Federal do Amazonas
ClinicalTrials.gov Identifier: NCT03323372     History of Changes
Other Study ID Numbers: UFAmazonas
First Posted: October 27, 2017    Key Record Dates
Last Update Posted: October 27, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Listerine
Fluorides
Sodium Fluoride
Dentin Sensitivity
Hypersensitivity
Immune System Diseases
Tooth Diseases
Stomatognathic Diseases
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents