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Tooth SensitivityPhase 2NCT03323372

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

A Phase 2 study testing 3% potassium nitrate and 0.25% sodium fluoride and 5% potassium nitrate and 2% sodium fluoride in people with Tooth Sensitivity, run by Universidade Federal do Amazonas.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Tooth Sensitivity
What is being tested?
3% potassium nitrate and 0.25% sodium fluoride and 5% potassium nitrate and 2% sodium fluoride
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
No sites listed yet
Study dates
21 Dec 2016to 20 May 2017
Phase
Phase 2
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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).

About this study

Official title: Different Concentrations of Potassium Nitrate in In-office Tooth Bleaching Sensitivity: a Randomized Clinical Trial

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.

Read the 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%.

Being tested
3% potassium nitrate and 0.25% sodium fluoride, 5% potassium nitrate and 2% sodium fluoride
Medical subject headings
Dentin Sensitivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 3% potassium nitrate and 0.25% sodium fluorideDrug

    Also called Ultra EZ

  • 5% potassium nitrate and 2% sodium fluorideDrug

    Also called Desensibilize KF 2%

Study groups in NCT03323372
Study groupRoleWhat they receive
control groupActive comparatorIn 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.
Receives: Drug: 5% potassium nitrate and 2% sodium fluoride
experimental groupExperimentalIn 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.
Receives: Drug: 3% potassium nitrate and 0.25% sodium fluoride

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. absolute risk of tooth sensibility

    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).

    Measured: 28 days

Secondary outcomes (3)

  1. sensitivity intensity

    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.

    Measured: 28 days

  2. effectiveness of tooth whitening - objective

    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.

    Measured: 28 days

  3. effectiveness of tooth whitening - subjective

    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.

    Measured: 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Oct 2017
  2. Study start21 Dec 2016
  3. Primary completion5 May 2017
  4. Study completion20 May 2017

Resources

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 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
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 blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03323372
Sponsor's protocol ID
UFAmazonas
Status last verified
Oct 2017
First submitted
2 Oct 2017
Last updated
27 Oct 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 3% potassium nitrate and 0.25% sodium fluoride and 5% potassium nitrate and 2% sodium fluoride in people with Tooth Sensitivity, run by Universidade Federal do Amazonas.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. 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: finished, as of the sponsor's last update on 27 Oct 2017. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

absolute risk of tooth sensibility (time frame: 28 days). 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 NCT03323372.

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 27 Oct 2017.

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