Medicaments Substances in Therapeutic UseNCT03523598
Potassium Nitrate and Post-bleaching Sensitivity
A study testing Potassium Nitrate Gel + Normal Toothpaste in people with Medicaments Substances in Therapeutic Use, run by Universidade Federal de Sergipe at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Medicaments Substances in Therapeutic Use
- What is being tested?
- Potassium Nitrate Gel + Normal Toothpaste
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteBrazil
- Study dates
- 26 May 2018to 1 Sep 2018
- Phase
- Interventional
- 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 to 29 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Potassium Nitrate Influence on Post in Office Bleaching Sensitivity: a Triple Blinded Randomized Clinical Trial
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.
Read the detailed description
This study will be a randomized, triple-blinded, placebo-controlled clinical trial, and split mouth study design.
The patients included will be submitted to two in-office bleaching sessions receiving the potassium nitrate 5% or placebo gel (prior the bleaching session, for 10 minutes), associated to normal toothpaste or potassium nitrate containing toothpaste (15 days prior and during the bleaching procedure).
A delay of 1 week between the sessions will be established.
Participants:
Patients included in this clinical trial will be between 18 and 29 years old with good oral health, all anterior tooth healthy and 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).
Patients with any of the six upper anterior teeth with caries, restoration, 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, pregnant or breastfeeding, lack the tretament will be also excluded.
Sample Size Calculation:
The sample calculation will be based on the primary binary outcome (sensitivity risk 24 hours after the procedure) for superiority trial. Power of the test will be set at 80%, considering a type I error of 0.05; risk to tooth sensitivity for control and experimental group of 25,2% with reduction of 60%. The calculation resulted in 75 patients.
Randomization:
A randomized list will be computer-generated by a person not involved in intervention or evaluation. The participants were defined as blocks in the randomization process, where the sequence of treatment (placebo or etodolac) will be randomly set for each block by using computer-generated tables (www.sealedenvelope.com). The sequence will be inserted into sealed envelopes numbered from 1 to 75 that were opened by the operator only at the moment of the intervention. The patients were numbered according to the sequence of enrollment. Neither the participant nor the operator will know the group allocation determining blinding to the protocol.
Baseline evaluation:
Prior to bleaching procedure, the teeth will be cleaned using rubber cups associated to pumice and water. The shades of six upper anterior teeth will be assessed on a baseline using the Vita classical guide scale.
Intervention:
Prior to each bleaching session, the patients will receive the potassium nitrate 2% or placebo Gel for 10 minutes. Also, Normal and potassium nitrate toothpaste will be used before and during the bleaching tretament, as follows: group 1: placebo gel + Colgate toothpaste; Group 2: Placebo gel + Nitrate toothpaste Sensodyne and Group 3: Potassium Nitrate + Colgate toothpaste.
Neither the operators responsible for intervention and evaluation nor the patients knew the content which treatment will be done.
A light-cured resin dam will be applied on the gingival tissue corresponding to the teeth to be bleached.
A 35% hydrogen peroxide based bleaching agent (DFL) will be mixed and applied on the vestibular surface of teeth, remaining for 40 minutes. After this time, the bleaching agent will be removed. A second session will be carried out after 1 week following the same procedures.
Evaluations:
The tooth sensitivity reported by patients will be assessed using a visual analog scale (VAS) and verbal rating scale (VRS). The VAS consisted of a scale 10 cm in length ranging from green (absence of pain) to red (unsupportable pain). The patient set his or her level of sensitivity by pointing to the color corresponding to this level, while the distance from this point to the green border will be recorded. For VRS, the patient reported his or her level of sensitivity based on scores: 0 = none, 1 = light, 2 = moderate, 3 = considerable and 4 = severe. The tooth sensitivity will be assessed during the bleaching, immediately after bleaching agent removal and after 24 hours. For this last assessment, only the VRS will be used. Tooth sensitivity will be measure: baseline, at 40 minutes during the bleaching procedure, after the bleaching procedure and 24 hours after. One week after each session the tooth color will be evaluated again using the same procedure described previously.
- Being tested
- Placebo gel + Normal Toothpaste, Placebo Gel + Potassium Nitrate Toothpaste, Potassium Nitrate Gel + Normal Toothpaste
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo gel + Normal ToothpasteOther
- 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.
Placebo Gel + Potassium Nitrate ToothpasteOther
- 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.
Potassium Nitrate Gel + Normal ToothpasteOther
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Placebo gel + Normal Toothpaste | Placebo comparator | The patient will receive the application of placebo gel on vestibular surface teeth, for 10 minutes and will use the normal toothpaste (Colgate). Receives: Other: Placebo gel + Normal Toothpaste |
| Placebo Gel + Potassium Nitrate Toothpaste | Experimental | The patient will receive the application of placebo gel on vestibular surface teeth, for 10 minutes and will use the Potassium nitrate toothpaste (Sensodyne). Receives: Other: Placebo Gel + Potassium Nitrate Toothpaste |
| Potassium Nitrate Gel + Normal Toothpaste | Experimental | The patient will receive the application of 5% Potassium nitrategel on vestibular surface teeth, for 10 minutes and will use the normal toothpaste (Colgate). Receives: Other: Potassium Nitrate Gel + Normal Toothpaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk to the tooth sensitivity (VAS)
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.
Measured: During the bleaching treatment
Risk to the tooth sensitivity (VRS)
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.
Measured: During the bleaching treatment
Secondary outcomes (7)
Level of tooth sensitivity (VAS)
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.
Measured: During the bleaching treatment
Level of tooth sensitivity (VRS)
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.
Measured: During the bleaching treatment
Risk after tooth sensitivity- after the procedure (VAS)
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.
Measured: 24 hours after the Bleaching procedure
Risk after tooth sensitivity- after the procedure (VRS)
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.
Measured: 24 hours after the Bleaching procedure
Level of tooth sensitivity - after the procedure (VAS)
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.
Measured: 24 hours after the Bleaching procedure
Level of tooth sensitivity - after the procedure (VRS)
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.
Measured: 24 hours after the Bleaching procedure
Bleaching Effectiveness
The color evaluation will be performed classical Vita guide.
Measured: Before the bleaching procedures (baseline) and end of the treatment (an average of 14 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2018
- Study start26 May 2018
- Primary completion1 Jun 2018
- Study completion1 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medicaments Substances in Therapeutic UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Sergipe
- Sponsor type
- University, hospital or other
- Collaborators
- Johnny Alexandre Oliveira Tavares
- Responsible party
- Principal investigator, Flavia Pardo Salata Nahsan, Universidade Federal de Sergipe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03523598
- Sponsor's protocol ID
- UFSergipe.
- Status last verified
- Aug 2020
- First submitted
- 9 Apr 2018
- Last updated
- 12 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Potassium Nitrate Influence on Post in Office Bleaching Sensitivity: a Triple Blinded Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03523598
- Acronym / sponsor ID
- UFSergipe.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Universidade Federal de SergipeUniversity, hospital or other
- Collaborators
- Johnny Alexandre Oliveira Tavares
- Study start
- 26 May 2018 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Sep 2018 (actual)
- First posted
- 14 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study will be a randomized, triple-blinded, placebo-controlled clinical trial, and split mouth study design.
The patients included will be submitted to two in-office bleaching sessions receiving the potassium nitrate 5% or placebo gel (prior the bleaching session, for 10 minutes), associated to normal toothpaste or potassium nitrate containing toothpaste (15 days prior and during the bleaching procedure).
A delay of 1 week between the sessions will be established.
Participants:
Patients included in this clinical trial will be between 18 and 29 years old with good oral health, all anterior tooth healthy and 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).
Patients with any of the six upper anterior teeth with caries, restoration, 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, pregnant or breastfeeding, lack the tretament will be also excluded.
Sample Size Calculation:
The sample calculation will be based on the primary binary outcome (sensitivity risk 24 hours after the procedure) for superiority trial. Power of the test will be set at 80%, considering a type I error of 0.05; risk to tooth sensitivity for control and experimental group of 25,2% with reduction of 60%. The calculation resulted in 75 patients.
Randomization:
A randomized list will be computer-generated by a person not involved in intervention or evaluation. The participants were defined as blocks in the randomization process, where the sequence of treatment (placebo or etodolac) will be randomly set for each block by using computer-generated tables (www.sealedenvelope.com). The sequence will be inserted into sealed envelopes numbered from 1 to 75 that were opened by the operator only at the moment of the intervention. The patients were numbered according to the sequence of enrollment. Neither the participant nor the operator will know the group allocation determining blinding to the protocol.
Baseline evaluation:
Prior to bleaching procedure, the teeth will be cleaned using rubber cups associated to pumice and water. The shades of six upper anterior teeth will be assessed on a baseline using the Vita classical guide scale.
Intervention:
Prior to each bleaching session, the patients will receive the potassium nitrate 2% or placebo Gel for 10 minutes. Also, Normal and potassium nitrate toothpaste will be used before and during the bleaching tretament, as follows: group 1: placebo gel + Colgate toothpaste; Group 2: Placebo gel + Nitrate toothpaste Sensodyne and Group 3: Potassium Nitrate + Colgate toothpaste.
Neither the operators responsible for intervention and evaluation nor the patients knew the content which treatment will be done.
A light-cured resin dam will be applied on the gingival tissue corresponding to the teeth to be bleached.
A 35% hydrogen peroxide based bleaching agent (DFL) will be mixed and applied on the vestibular surface of teeth, remaining for 40 minutes. After this time, the bleaching agent will be removed. A second session will be carried out after 1 week following the same procedures.
Evaluations:
The tooth sensitivity reported by patients will be assessed using a visual analog scale (VAS) and verbal rating scale (VRS). The VAS consisted of a scale 10 cm in length ranging from green (absence of pain) to red (unsupportable pain). The patient set his or her level of sensitivity by pointing to the color corresponding to this level, while the distance from this point to the green border will be recorded. For VRS, the patient reported his or her level of sensitivity based on scores: 0 = none, 1 = light, 2 = moderate, 3 = considerable and 4 = severe. The tooth sensitivity will be assessed during the bleaching, immediately after bleaching agent removal and after 24 hours. For this last assessment, only the VRS will be used. Tooth sensitivity will be measure: baseline, at 40 minutes during the bleaching procedure, after the bleaching procedure and 24 hours after. One week after each session the tooth color will be evaluated again using the same procedure described previously.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo gel + Normal Toothpaste | Placebo comparator | Other: Placebo gel + Normal ToothpasteThe patient will receive the application of placebo gel on vestibular surface teeth, for 10 minutes and will use the normal toothpaste (Colgate). |
| Placebo Gel + Potassium Nitrate Toothpaste | Experimental | Other: Placebo Gel + Potassium Nitrate ToothpasteThe patient will receive the application of placebo gel on vestibular surface teeth, for 10 minutes and will use the Potassium nitrate toothpaste (Sensodyne). |
| Potassium Nitrate Gel + Normal Toothpaste | Experimental | Other: Potassium Nitrate Gel + Normal ToothpasteThe patient will receive the application of 5% Potassium nitrategel on vestibular surface teeth, for 10 minutes and will use the normal toothpaste (Colgate). |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Placebo gel + Normal Toothpaste |
| 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. | Other | Placebo Gel + Potassium Nitrate Toothpaste |
| 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. | Other | Potassium Nitrate Gel + Normal Toothpaste |
Primary outcome
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.
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.
7 secondary outcomes
Level of tooth sensitivity (VAS)
Time frame: During the bleaching treatment
Level of tooth sensitivity (VRS)
Time frame: During the bleaching treatment
Risk after tooth sensitivity- after the procedure (VAS)
Time frame: 24 hours after the Bleaching procedure
Risk after tooth sensitivity- after the procedure (VRS)
Time frame: 24 hours after the Bleaching procedure
Level of tooth sensitivity - after the procedure (VAS)
Time frame: 24 hours after the Bleaching procedure
Level of tooth sensitivity - after the procedure (VRS)
Time frame: 24 hours after the Bleaching procedure
Bleaching Effectiveness
Time frame: Before the bleaching procedures (baseline) and end of the treatment (an average of 14 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Potassium Nitrate Gel + Normal Toothpaste in people with Medicaments Substances in Therapeutic Use, run by Universidade Federal de Sergipe at 1 site in Brazil.
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 4 inclusion and 6 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 12 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Risk to the tooth sensitivity (VAS) (time frame: During the bleaching treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Aug 2020.