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Potassium Nitrate and Post-bleaching Sensitivity

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ClinicalTrials.gov Identifier: NCT03523598
Recruitment Status : Not yet recruiting
First Posted : May 14, 2018
Last Update Posted : May 18, 2018
Sponsor:
Collaborator:
Johnny Alexandre Oliveira Tavares
Information provided by (Responsible Party):
Flavia Pardo Salata Nahsan, Universidade Federal de Sergipe

Brief Summary:

This study will determine the effectiveness of the use of desensitivity gels prior in office bleaching on risk and intensity of tooth sensitivity caused by in-office bleaching using 35% hydrogen peroxide and using different types of potassium nitrate. Materials and Methods: Seventy five patients will be selected for this triple-blind, randomized, cross-over, placebo-controlled clinical trial. 10 minutes prior to bleaching procedure, patients will receive the the potassium nitrate 2% or placebo gel application on vestibular surface and Toothpaste 15 days before start the bleaching procedure (group 1: placebo gel + Colgate toothpaste; Group 2: Placebo gel + Nitrate toothpaste Sensodyne and Group 3: Potassium Nitrate + Colgate toothpaste). The whitening treatment with 35% hydrogen peroxide will be carried out in two sessions with a 7-day interval.

Tooth sensitivity will be assessed before, during and 24 hours after the procedure using analog visual and verbal scales. Color alteration will be assessed by a Vita Guide scale at the end of the last session. Relative risk to sensitivity will be calculated and adjusted by session; while comparison of overall risk will performed by McNemar's test. Data on the sensitivity level and color shade will be subjected to the Friedman, Wilcoxon (α = 0.05). If necessary, multiple comparation will be done using Tukey's test.


Condition or disease Intervention/treatment Phase
Medicaments Substances in Therapeutic Use Other: Placebo gel + Normal Toothpaste Other: Placebo Gel + Potassium Nitrate Toothpaste Other: Potassium Nitrate Gel + Normal Toothpaste Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Potassium Nitrate Influence on Post in Office Bleaching Sensitivity: a Triple Blinded Randomized Clinical Trial
Estimated Study Start Date : May 26, 2018
Estimated Primary Completion Date : June 1, 2018
Estimated Study Completion Date : September 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy Potassium

Arm Intervention/treatment
Placebo Comparator: Placebo gel + Normal Toothpaste
The patient will receive the application of placebo gel on vestibular surface teeth, for 10 minutes and will use the normal toothpaste (Colgate).
Other: Placebo gel + Normal Toothpaste
  • 15 days before and during the period of bleaching sessions: Tooth paste used will be normal (Colgate).
  • Teeth will be cleaned using rubber cups associated to pumice and water;
  • Relative isolation with roller cotton will be done;
  • Prior to each bleaching session, the patients will receive the placebo gel application on vestibular surface, for 10 minutes.
  • Gingival dam will be performed using a fluid resin.
  • A 35% hydrogen peroxide based bleaching agent will applied on the vestibular surface of teeth, remaining for 40 minutes.

Experimental: Placebo Gel + Potassium Nitrate Toothpaste
The patient will receive the application of placebo gel on vestibular surface teeth, for 10 minutes and will use the Potassium nitrate toothpaste (Sensodyne).
Other: Placebo Gel + Potassium Nitrate Toothpaste
  • 15 days before and during the period of bleaching sessions: Tooth paste used will be normal tooth paste (Colgate).
  • Teeth will be cleaned using rubber cups associated to pumice and water;
  • Relative isolation with roller cotton will be done;
  • Prior to each bleaching session, the patients will receive the 5% Potassium Nitrate gel application on vestibular surface, for 10 minutes.
  • Gingival dam will be performed using a fluid resin.
  • A 35% hydrogen peroxide based bleaching agent will applied on the vestibular surface of teeth, remaining for 40 minutes.

Experimental: Potassium Nitrate Gel + Normal Toothpaste
The patient will receive the application of 5% Potassium nitrategel on vestibular surface teeth, for 10 minutes and will use the normal toothpaste (Colgate).
Other: Potassium Nitrate Gel + Normal Toothpaste
  • 15 days before and during the period of bleaching sessions: Tooth paste used will be Potassium Nitrate containing (Sensodyne).
  • Teeth will be cleaned using rubber cups associated to pumice and water;
  • Relative isolation with roller cotton will be done;
  • Prior to each bleaching session, the patients will receive the placebo gel application on vestibular surface, for 10 minutes.
  • Gingival dam will be performed using a fluid resin.
  • A 35% hydrogen peroxide based bleaching agent will applied on the vestibular surface of teeth, remaining for 40 minutes.




Primary Outcome Measures :
  1. Risk to the tooth sensitivity (VAS) [ Time Frame: During the bleaching treatment ]
    The tooth sensitivity will be assessed using a Visual analogue (VAS) scale. VAS consisted of a 10-cm scale 0 (no sensitivity) 10 (unbearable sensitivity). A slightly air-stream will be applied over the buccal surfaces of the central incisors, and the patients will record their sensitivity perception by pointing with a pen on the scale. The distance between the marking and the border of scale, relative to the absence of sensitivity will be measured. The measurements will be scored according to the distance from 0, using a digital caliper. The risk of tooth sensitivity will be determined by relative risk assessed by ratio between absolute risk of experimental condition by those observed in control. The 95% confidence interval will be calculated.

  2. Risk to the tooth sensitivity (VRS) [ Time Frame: During the bleaching treatment ]
    The tooth sensitivity will be evaluated using a 5-point Verbal rating scale (VRS), where 0 = none, 1 = mild, 2 = moderate, 3 = considerable and 4 = severe. Score different from 0 will determine presence of sensitivity.The risk of tooth sensitivity will be determined by relative risk assessed by ratio between absolute risk of experimental condition by those observed in control. The 95% confidence interval will be calculated.


Secondary Outcome Measures :
  1. Level of tooth sensitivity (VAS) [ Time Frame: During the bleaching treatment ]
    The tooth sensitivity will be assessed using a Visual analogue (VAS) scale. VAS consisted of a 10-cm scale 0 (no sensitivity) 10 (unbearable sensitivity). A slightly air-stream will be applied over the buccal surfaces of the central incisors, and the patients will record their sensitivity perception by pointing with a pen on the scale. The distance between the marking and the border of scale, relative to the absence of sensitivity will be measured. The measurements will be scored according to the distance from 0, using a digital caliper. The risk of tooth sensitivity will be determined by relative risk assessed by ratio between absolute risk of experimental condition by those observed in control. The 95% confidence interval will be calculated.

  2. Level of tooth sensitivity (VRS) [ Time Frame: During the bleaching treatment ]
    The tooth sensitivity will be evaluated using a 5-point Verbal rating scale (VRS), where 0 = none, 1 = mild, 2 = moderate, 3 = considerable and 4 = severe. Score different from 0 will determine presence of sensitivity.The risk of tooth sensitivity will be determined by relative risk assessed by ratio between absolute risk of experimental condition by those observed in control. The 95% confidence interval will be calculated.

  3. Risk after tooth sensitivity- after the procedure (VAS) [ Time Frame: 24 hours after the Bleaching procedure ]
    The tooth sensitivity will be assessed using a Visual analogue (VAS) scale. VAS consisted of a 10-cm scale 0 (no sensitivity) 10 (unbearable sensitivity). A slightly air-stream will be applied over the buccal surfaces of the central incisors, and the patients will record their sensitivity perception by pointing with a pen on the scale. The distance between the marking and the border of scale, relative to the absence of sensitivity will be measured. The measurements will be scored according to the distance from 0, using a digital caliper. The risk of tooth sensitivity will be determined by relative risk assessed by ratio between absolute risk of experimental condition by those observed in control. The 95% confidence interval will be calculated.

  4. Risk after tooth sensitivity- after the procedure (VRS) [ Time Frame: 24 hours after the Bleaching procedure ]
    The tooth sensitivity will be evaluated using a 5-point Verbal rating scale (VRS), where 0 = none, 1 = mild, 2 = moderate, 3 = considerable and 4 = severe. Score different from 0 will determine presence of sensitivity.The risk of tooth sensitivity will be determined by relative risk assessed by ratio between absolute risk of experimental condition by those observed in control. The 95% confidence interval will be calculated.

  5. Level of tooth sensitivity - after the procedure (VAS) [ Time Frame: 24 hours after the Bleaching procedure ]
    The tooth sensitivity will be assessed using a Visual analogue (VAS) scale. VAS consisted of a 10-cm scale 0 (no sensitivity) 10 (unbearable sensitivity). A slightly air-stream will be applied over the buccal surfaces of the central incisors, and the patients will record their sensitivity perception by pointing with a pen on the scale. The distance between the marking and the border of scale, relative to the absence of sensitivity will be measured. The measurements will be scored according to the distance from 0, using a digital caliper. The risk of tooth sensitivity will be determined by relative risk assessed by ratio between absolute risk of experimental condition by those observed in control. The 95% confidence interval will be calculated.

  6. Level of tooth sensitivity - after the procedure (VRS) [ Time Frame: 24 hours after the Bleaching procedure ]
    The tooth sensitivity will be evaluated using a 5-point Verbal rating scale (VRS), where 0 = none, 1 = mild, 2 = moderate, 3 = considerable and 4 = severe. Score different from 0 will determine presence of sensitivity.The risk of tooth sensitivity will be determined by relative risk assessed by ratio between absolute risk of experimental condition by those observed in control. The 95% confidence interval will be calculated.

  7. Bleaching Effectiveness [ Time Frame: Before the bleaching procedures (baseline) and end of the treatment (an average of 14 days) ]
    The color evaluation will be performed classical Vita guide.



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Ages Eligible for Study:   18 Years to 29 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients included in this clinical trial will be between 18 and 29 years old with good oral health;
  • All anterior tooth healthy
  • To agree with TCLE (Term of Free and Informed Consent).
  • Only patients presenting all six upper anterior teeth with shade mismatching with 2.5 M2 (VitaClassicalscale, Vita-Zahnfabrik, Bad Sackingen, Germany).

Exclusion Criteria:

  • Patients with any of the six upper anterior teeth with caries
  • Restoration in anterior tooth, severe discoloration (e.g., stains caused by tetracycline), enamel hypoplasia, gingival recession, dentin exposure, pulpitis, or endodontics will be excluded.
  • Participants submitted to previous bleaching procedures
  • Presenting prior tooth sensitivity
  • known allergy to any component of medication used in the study
  • being pregnant or breastfeeding.

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): NCT03523598


Locations
Brazil
Federal University of Sergipe Not yet recruiting
Aracaju, Sergipe, Brazil, 49060-108
Contact: UFS         
Sponsors and Collaborators
Universidade Federal de Sergipe
Johnny Alexandre Oliveira Tavares

Responsible Party: Flavia Pardo Salata Nahsan, Clinical Professor, Universidade Federal de Sergipe
ClinicalTrials.gov Identifier: NCT03523598     History of Changes
Other Study ID Numbers: UFSergipe.
First Posted: May 14, 2018    Key Record Dates
Last Update Posted: May 18, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hydrogen Peroxide
Listerine
Sodium Fluoride
Anti-Infective Agents, Local
Anti-Infective Agents
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs