Dentin SensitivityPhase 1NCT03434782
Effect of Laser and Potassium Nitrate Application on the Sensitivity Control in Bleached Teeth
A Phase 1 study testing In-office dental bleaching, Low Level Laser Therapy and 5% potassium nitrate / 2% sodium fluoride gel in people with Dentin Sensitivity, run by Universidade Federal do Para at 1 site in Brazil.
Trial summary
To investigate the effects of desensitizing agents on the dental bleaching process, testing the hypothesis that they may control dental sensitivity. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Dentin Sensitivity
- What is being tested?
- In-office dental bleaching, Low Level Laser Therapy and 5% potassium nitrate / 2% sodium fluoride gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- 24 Apr 2017to 15 Jan 2018
- Phase
- Phase 1
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Absence of active carious lesions;
- Never undergone bleaching therapy;
- Good oral hygiene;
- Do not present hypersensitivity;
- Do not smoke;
- Not being pregnant;
- Presence of at least 28 teeth in oral cavity.
Who cannot join
- Presence of periodontal disease;
- Presence of cracks or fractures;
- Presence of restorations and prostheses;
- Presence of gastroesophageal dysfunction;
- Patients with severe internal dental dimming;
- Presence of periodontal disease;
- Presence of dentin exposure in anterior and/or posterior teeth.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Low-level Light Therapy Associated With Potassium Nitrate in the Control of Post-bleaching Dental Sensitivity: a Randomized, Double-blind, Split-mouth, Controlled Trial
To investigate the effects of desensitizing agents on the dental bleaching process, testing the hypothesis that they may control dental sensitivity.
Read the detailed description
The objective of this double blind, randomized and controlled clinical study, was to evaluate the efficacy of potassium nitrate / sodium fluoride (KNO3 / KF) gel associated with LLLT (Low Level Light Therapy) on teeth that were exposed to 35% hydrogen peroxide during 3 weeks of bleaching treatment. Methods: 50 volunteers were evaluated through the split-mouth model, where the hemiarcates were randomized and later allocated in one of the experimental groups: G1 (negative control)- group with no desensitizing treatment, only bleached; G2 (positive control)- group treated with LLLT + placebo gel; G3- group treated with placebo laser application + 5% KNO3 / 2% KF gel; and G4- group treated with LLLT + 5% KNO3 / 2% KF gel.
- Conditions
- Dentin Sensitivity
- Being tested
- In-office dental bleaching, Low Level Laser Therapy, 5% potassium nitrate / 2% sodium fluoride gel
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-office dental bleachingDrug
Also called 35% hydrogen peroxide
The group will receive in-office bleaching treatment. Three 15-minute applications of the 35% hydrogen peroxide gel were performed, totaling 45 minutes in each of the 3 sessions, with a 7-day interval.
Low Level Laser TherapyDrug
Also called LLLT
It will be used the infrared spectrum with wavelength of 808 nm in its active environment AsGaAl, in two points: cervical and apical region of the incisors, canines and premolars.
5% potassium nitrate / 2% sodium fluoride gelDrug
Also called desensitizing therapy
5% potassium nitrate / 2% sodium fluoride gel will be applied for 10 minutes on the vestibular surface of all pre-bleached dental elements, following the manufacturer's protocol.
| Study group | Role | What they receive |
|---|---|---|
| G1- Negative Control | Experimental | Group with no desensitizing treatment. Prior to bleaching therapy, a water-soluble placebo gel, with non-active agent will be applied to dental vestibular surfaces. After bleaching therapy, the LASER tip will be positioned in two points (apical and cervical), without light emission (placebo). Receives: Drug: In-office dental bleaching |
| G2- LASER (Positive Control) | Experimental | Group treated with placebo gel before bleaching and with LLLT after in-office bleaching. Receives: Drug: In-office dental bleaching; Drug: Low Level Laser Therapy |
| G3- KNO3 (Positive Control) | Experimental | Group treated with desensitizing gel before bleaching and after in-office bleaching, the LASER tip will be positioned in two points (apical and cervical), without light emission (placebo). Receives: Drug: In-office dental bleaching; Drug: 5% potassium nitrate / 2% sodium fluoride gel |
| G4- KNO3 + LASER | Experimental | Group treated with desensitizing gel before bleaching and with LLLT after in-office bleaching. Receives: Drug: In-office dental bleaching; Drug: Low Level Laser Therapy; Drug: 5% potassium nitrate / 2% sodium fluoride gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Stimulated pain intensity in different assessment times (P15)
The stimulated pain intensity was self reported by the patients with a modified visual analog scale, from 0 to 3, where 0 means "no pain", 1 is "mild pain", 2 is "moderate pain" and 3 is "severe pain". For all groups, the patients evaluated the stimulated pain intensity two times per session: before and after the treatment in the same day. Thus, in total each patient reported the pain intensity 6 times, two times in the first day (1st session), two times in the eighth day (2nd session) and two times in the fifteenth day (3rd session).
Measured: 15 days, with assessments in the 1st, 8th and 15th day of the treatment
Secondary outcomes (1)
Non-stimulated pain intensity measure, (P21)
Self reported non-stimulated pain intensity was assessed daily, during 21 days, through self-perception questionnaire, answered by the patients from the first tooth bleaching session until one week after the last session. The evaluation was performed by each patient, according to a modified visual analog scale, as follows: 0- no pain, 1 mild pain, 2 - moderate pain and 3 -severe pain
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2018
- Study start24 Apr 2017
- Primary completion24 Nov 2017
- Study completion15 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dentin SensitivityStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Para
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Principal investigator, Cecy Martins Silva, Universidade Federal do Para
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03434782
- Sponsor's protocol ID
- UFPara-002
- Status last verified
- Feb 2018
- First submitted
- 16 Jan 2018
- Last updated
- 15 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Reis A, Dalanhol AP, Cunha TS, Kossatz S, Loguercio AD. Assessment of tooth sensitivity using a desensitizer before light-activated bleaching. Oper Dent. 2011 Jan-Feb;36(1):12-7. doi: 10.2341/10-148-CR. Epub 2011 Mar 24.
PubMed 21488723Moosavi H, Arjmand N, Ahrari F, Zakeri M, Maleknejad F. Effect of low-level laser therapy on tooth sensitivity induced by in-office bleaching. Lasers Med Sci. 2016 May;31(4):713-9. doi: 10.1007/s10103-016-1913-z. Epub 2016 Mar 10.
PubMed 26964798
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low-level Light Therapy Associated With Potassium Nitrate in the Control of Post-bleaching Dental Sensitivity: a Randomized, Double-blind, Split-mouth, Controlled Trial
- ClinicalTrials.gov ID
- NCT03434782
- Acronym / sponsor ID
- UFPara-002
- Conditions
- Dentin Sensitivity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Universidade Federal do ParaUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- 24 Apr 2017 (actual)
- Primary completion
- 24 Nov 2017 (actual)
- Study completion
- 15 Jan 2018 (actual)
- First posted
- 15 Feb 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.
To investigate the effects of desensitizing agents on the dental bleaching process, testing the hypothesis that they may control dental sensitivity.
Detailed description
The objective of this double blind, randomized and controlled clinical study, was to evaluate the efficacy of potassium nitrate / sodium fluoride (KNO3 / KF) gel associated with LLLT (Low Level Light Therapy) on teeth that were exposed to 35% hydrogen peroxide during 3 weeks of bleaching treatment. Methods: 50 volunteers were evaluated through the split-mouth model, where the hemiarcates were randomized and later allocated in one of the experimental groups: G1 (negative control)- group with no desensitizing treatment, only bleached; G2 (positive control)- group treated with LLLT + placebo gel; G3- group treated with placebo laser application + 5% KNO3 / 2% KF gel; and G4- group treated with LLLT + 5% KNO3 / 2% KF gel.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| G1- Negative Control | Experimental | Drug: In-office dental bleachingGroup with no desensitizing treatment. Prior to bleaching therapy, a water-soluble placebo gel, with non-active agent will be applied to dental vestibular surfaces. After bleaching therapy, the LASER tip will be positioned in two points (apical and cervical), without light emission (placebo). |
| G2- LASER (Positive Control) | Experimental | Drug: In-office dental bleaching, Drug: Low Level Laser TherapyGroup treated with placebo gel before bleaching and with LLLT after in-office bleaching. |
| G3- KNO3 (Positive Control) | Experimental | Drug: In-office dental bleaching, Drug: 5% potassium nitrate / 2% sodium fluoride gelGroup treated with desensitizing gel before bleaching and after in-office bleaching, the LASER tip will be positioned in two points (apical and cervical), without light emission (placebo). |
| G4- KNO3 + LASER | Experimental | Drug: In-office dental bleaching, Drug: Low Level Laser Therapy, Drug: 5% potassium nitrate / 2% sodium fluoride gelGroup treated with desensitizing gel before bleaching and with LLLT after in-office bleaching. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Absence of active carious lesions;
- Never undergone bleaching therapy;
- Good oral hygiene;
- Do not present hypersensitivity;
- Do not smoke;
Key exclusion criteria (7 listed)
- Presence of periodontal disease;
- Presence of cracks or fractures;
- Presence of restorations and prostheses;
- Presence of gastroesophageal dysfunction;
- Patients with severe internal dental dimming;
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 |
|---|---|---|
| In-office dental bleachingAlso: 35% hydrogen peroxideThe group will receive in-office bleaching treatment. Three 15-minute applications of the 35% hydrogen peroxide gel were performed, totaling 45 minutes in each of the 3 sessions, with a 7-day interval. | Drug | G1- Negative Control, G2- LASER (Positive Control), G3- KNO3 (Positive Control), G4- KNO3 + LASER |
| Low Level Laser TherapyAlso: LLLTIt will be used the infrared spectrum with wavelength of 808 nm in its active environment AsGaAl, in two points: cervical and apical region of the incisors, canines and premolars. | Drug | G2- LASER (Positive Control), G4- KNO3 + LASER |
| 5% potassium nitrate / 2% sodium fluoride gelAlso: desensitizing therapy5% potassium nitrate / 2% sodium fluoride gel will be applied for 10 minutes on the vestibular surface of all pre-bleached dental elements, following the manufacturer's protocol. | Drug | G3- KNO3 (Positive Control), G4- KNO3 + LASER |
Primary outcome
Change in Stimulated pain intensity in different assessment times (P15)
Time frame: 15 days, with assessments in the 1st, 8th and 15th day of the treatment
The stimulated pain intensity was self reported by the patients with a modified visual analog scale, from 0 to 3, where 0 means "no pain", 1 is "mild pain", 2 is "moderate pain" and 3 is "severe pain". For all groups, the patients evaluated the stimulated pain intensity two times per session: before and after the treatment in the same day. Thus, in total each patient reported the pain intensity 6 times, two times in the first day (1st session), two times in the eighth day (2nd session) and two times in the fifteenth day (3rd session).
1 secondary outcome
Non-stimulated pain intensity measure, (P21)
Time frame: 21 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 15 Feb 2018.
- Background: PubMed 21488723Reis A, Dalanhol AP, Cunha TS, Kossatz S, Loguercio AD. Assessment of tooth sensitivity using a desensitizer before light-activated bleaching. Oper Dent. 2011 Jan-Feb;36(1):12-7. doi: 10.2341/10-148-CR. Epub 2011 Mar 24.
- Results publication: PubMed 26964798Moosavi H, Arjmand N, Ahrari F, Zakeri M, Maleknejad F. Effect of low-level laser therapy on tooth sensitivity induced by in-office bleaching. Lasers Med Sci. 2016 May;31(4):713-9. doi: 10.1007/s10103-016-1913-z. Epub 2016 Mar 10.
- 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 Phase 1 study testing In-office dental bleaching, Low Level Laser Therapy and 5% potassium nitrate / 2% sodium fluoride gel in people with Dentin Sensitivity, run by Universidade Federal do Para 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 7 inclusion and 7 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 15 Feb 2018. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Change in Stimulated pain intensity in different assessment times (P15) (time frame: 15 days, with assessments in the 1st, 8th and 15th day of the treatment). 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 NCT03434782, which also lists 2 linked publications.
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 15 Feb 2018.