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Potassium Oxalate and Potassium Nitrate and Post-bleaching Sensitivity

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ClinicalTrials.gov Identifier: NCT02941653
Recruitment Status : Completed
First Posted : October 21, 2016
Last Update Posted : April 11, 2018
Sponsor:
Information provided by (Responsible Party):
Flavia Pardo Salata Nahsan, Universidade Federal de Sergipe

Brief Summary:
Objectives: 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. Materials and Methods: Fourty seven 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% and potassium oxalate 5% desensitivity gel application on vestibular surface. 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 bleach guide scale and Vita Easy shade spectrophotometer 7 days after each 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 for both scales and color shade will be subjected to the Friedman, Wilcoxon and Mann-Whitney tests, respectively (α = 0.05).

Condition or disease Intervention/treatment Phase
Medicaments Substances in Therapeutic Use Device: Potassium nitrate 2% gel Device: Potassium oxalate 5% gel Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Potassium Oxalate and Potassium Nitrate on Tooth Sensitivity Related to in Office Bleaching: Randomized Clinical Trial
Actual Study Start Date : November 2016
Actual Primary Completion Date : July 2017
Actual Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy Potassium

Arm Intervention/treatment
Active Comparator: Control: Potassium Nitrate 2% gel
The patient will receive the application of potassium nitrate 2% gel on vestibular surface teeth, for 10 minutes.
Device: Potassium nitrate 2% gel
  • 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 potassium nitrate 2% desensitivity gel application on vestibular surface, for 10 minutes.
  • Gingival dam will be performed using a fluid resin (Top Dam, FGM, Brazil)
  • A 35% hydrogen peroxide based bleaching agent will be mixed and applied on the vestibular surface of teeth, remaining for 40 minutes.

Experimental: Intervention: Potassium Oxalate 5% gel
The patient will receive the application of potassium oxalate 5% gel on vestibular surface teeth, for 10 minutes.
Device: Potassium oxalate 5% gel
  • 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 potassium OXALATE 5%
  • Gingival dam will be performed using a fluid resin (Top Dam, FGM, Brazil) desensitivity gel application on vestibular surface, for 10 minutes.
  • A 35% hydrogen peroxide based bleaching agent will be mixed and applied on the vestibular surface of teeth, remaining for 40 minutes.




Primary Outcome Measures :
  1. Risk to the tooth sensitivity [ Time Frame: During the bleaching treatment. ]
    The tooth sensitivity will be assessed using a Visual analogue (VAS) and verbal scales. 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 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 [ Time Frame: During the Bleaching procedure ]
    The tooth sensitivity will be assessed using a Visual analogue (VAS) and verbal scales. 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 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.

  2. Risk after tooth sensitivity- after the procedure [ Time Frame: 24 hours after the Bleaching procedure ]
    The tooth sensitivity will be assessed using a Visual analogue (VAS) and verbal scales. 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 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. Level of tooth sensitivity - after the procedure [ Time Frame: 24 hours after the Bleaching procedure ]
    The tooth sensitivity will be assessed using a Visual analogue (VAS) and verbal scales. 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 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.

  4. Bleaching Effectiveness [ Time Frame: Before the bleaching procedures and 7 days after this ]
    The color evaluation will be performed using CIE L*a*b* color system, classical Vita guide and Vita bleachguide. For the CIE L*a*b* and classical vita guide, the shade will be determined using a spectrophotometer (Easy Shade Compact, Vita-Zahnfabrik, Bad Säckinge, Germany). The spectrophotometer also will inform the shade in classical Vita guide.



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients included in this clinical trial will be at least 18 years old with good oral health;
  • Patients presenting all six upper anterior teeth with shade mismatching with 2.5 M2 (Vita Bleachguide 3D-Master scale, Vita-Zahnfabrik, Bad Sackingen, Germany) or darker will be included.

Exclusion Criteria:

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

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): NCT02941653


Locations
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Brazil
Flavia Pardo Salata Nahsan
Aracaju, Sergipe, Brazil, 49060-100
Sponsors and Collaborators
Universidade Federal de Sergipe
Investigators
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Principal Investigator: Flavia Pardo S Nahsan, PhD Universidade Federal de Sergipe

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Responsible Party: Flavia Pardo Salata Nahsan, Principal Investigator, Universidade Federal de Sergipe
ClinicalTrials.gov Identifier: NCT02941653     History of Changes
Other Study ID Numbers: UFSergipeHU
First Posted: October 21, 2016    Key Record Dates
Last Update Posted: April 11, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Hypersensitivity
Immune System Diseases