HypersensitivityNCT06538129
Assessment of Er:YAG Laser for the Control of Hypersensitivity During Tooth Whitening With Hydrogen Peroxide
A study testing Hypersensitivity prevention protocol with Er:YAG laser and Hypersensitivity prevention protocol with neutral sodium fluoride gel in people with Hypersensitivity and Hypersensitivity, Immediate, run by University of Nove de Julho.
Trial summary
Introduction: Tooth whitening is an aesthetic procedure with rapid results that improves the self-esteem and self-image of patients. However, one of the side effects is dentinal hypersensitivity. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypersensitivity, Hypersensitivity, Immediate, Hypersensitivity Response
- What is being tested?
- Hypersensitivity prevention protocol with Er:YAG laser and Hypersensitivity prevention protocol with neutral sodium fluoride gel
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2024to 1 Sep 2026
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- All anterior teeth present without caries or restorations;
- Absence of cervical lesions, dental pain and hypersensitivity prior to treatment;
- Not having previously undergone any tooth whitening procedure.
Who cannot join
- Smokers;
- Pregnant or nursing women;
- Individuals with gingivitis or periodontitis, those with enamel cracks detected by the transillumination test;
- Those with enamel defects or stains caused by tetracycline;
- Those with systemic diseases;
- Those taking nonsteroidal anti-inflammatory.
About this study
Official title: Assessment of Er:YAG Laser for the Control of Hypersensitivity During Tooth Whitening With Hydrogen Peroxide: Protocol for a Split-Mouth Controlled Clinical Trial
Introduction: Tooth whitening is an aesthetic procedure with rapid results that improves the self-esteem and self-image of patients. However, one of the side effects is dentinal hypersensitivity. The aim of the study is to assess the effectiveness of Er:YAG laser administered prior to bleaching with 35% hydrogen peroxide hypersensitivity.
Methods: The maxillary arch of participants 18 to 45 years of age will be treated using the split-mouth method. Grupo experimental: Hypersensitivity prevention protocol with Er:YAG laser followed by bleaching with 35% hydrogen peroxide; control group: hypersensitivity prevention protocol with neutral sodium fluoride for four minutes followed by bleaching with 35% hydrogen peroxide. Er:YAG laser (2940 nm) will be used with the following parameters: 0.15 W, 10 mJ, 15 Hz and SP mode (pulse duration: 300 µs), TIP: Cylindrical Quartz 1000/4, using the H14 handpiece (H14 for LightWalker AT; Fotona dd, Ljubljana, Slovenia). Each tooth (central incisor, lateral incisor and canine) will be irradiated twice for 10 s in an unfocused scanning motion in the cervical region at a working distance of 1 cm. The absolute risk and intensity of dentinal hypersensitivity during treatment will be assessed using the visual analogue scale. The change in color will be determined using an intraoral spectrophotometer in contact with the tooth. Assessments will be conducted before and after preventive treatment, immediately after treatment as well as 48 hours and one week after treatment. Different statistical tests will be used, with the significance level set at 5% (p ≤ 0.05).
- Being tested
- Hypersensitivity prevention protocol with Er:YAG laser, Hypersensitivity prevention protocol with neutral sodium fluoride gel
- Medical subject headings
- Hypersensitivity, Hypersensitivity, Immediate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypersensitivity prevention protocol with Er:YAG laserProcedure or surgery
1.Prophylaxis using airflow system with erythritol, potency 5, water regulator 5; 2.Initial assessment of hypersensitivity using visual analogue scale (VAS); 3.Color assessment (canines, central incisors and lateral incisors) with digital spectrophotometer (Vita Easyshade,); 4.Placement of dental dam followed by photoactivation with Valo cordless curing light 5.Hypersensitivity prevention protocol with Er:YAG laser in cervical region (central incisor, lateral incisor and canine); 6.Application of whitening gel (1 mm in thickness) with 35% hydrogen peroxide on maxillary arch (Clareador Whiteness HP; FGM), left to react for 15 minutes; 7.Removal of whitening gel; 8.Repeat procedures (steps 7 and 8); 9.Assessment of hypersensitivity immediately after hypersensitivity prevention procedure, immediately after bleaching, 48 after bleaching and one week after bleaching; 10.Color assessment with digital immediately after bleaching, 48 after bleaching and one week after bleaching.
Hypersensitivity prevention protocol with neutral sodium fluoride gelProcedure or surgery
1.Prophylaxis using airflow system with erythritol, potency 5, water regulator 5; 2.Initial assessment of hypersensitivity using the VAS; 3.Color assessment (canines, central incisors and lateral incisors) with digital spectrophotometer (Vita Easyshade); 4.Placement of dental dam followed by photoactivation with Valo cordless; 5.Hypersensitivity prevention protocol with neutral sodium fluoride gel for 4 minutes (central incisor, lateral incisor and canine); 6.Application of whitening gel (1 mm in thickness) with 35% hydrogen peroxide on maxillary arch (Clareador Whiteness HP; FGM), left to react for 15 minutes; 7.Removal of whitening gel; 8.Repeat procedures (steps 7 and 8); 9.Assessment of hypersensitivity immediately after hypersensitivity prevention procedure, immediately after bleaching, 48 after bleaching and one week after bleaching; 10.Color assessment with digital spectrophotometer immediately after bleaching, 48 after bleaching and one week after bleaching.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | The participants will receive the hypersensitivity prevention protocol with Er:YAG laser in cervical region (central incisor, lateral incisor and canine). Receives: Procedure: Hypersensitivity prevention protocol with Er:YAG laser |
| Control Group | Experimental | The participants will receive the hypersensitivity prevention protocol with neutral sodium fluoride gel for 4 minutes (central incisor, lateral incisor and canine). Receives: Procedure: Hypersensitivity prevention protocol with neutral sodium fluoride gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Dental Hypersensitivity
The patients will be given a questionnaire with the VAS for the measurement of dental hypersensitivity. The patient will indicate the severity of tooth sensitivity by marking a vertical line along a 10-cm horizontal line with 0 (no sensitivity) printed at one end and 10 (severe sensitivity) at the other end for all teeth that receive treatment.
Measured: At baseline as well as after the hypersensitivity prevention protocol, immediately after bleaching, 48 hours after bleaching and one week after bleaching.
Secondary outcomes (1)
Color assessment (instrumental method)
A contact intraoral spectrophotometer (Vita Easyshade, Vita-Zanhnfabrik, Bad Säckingen, Germany) will be used following the manufacturer's instructions and the method described by Kim-Pusateri et al. (2009). Readings will be made in the central portion of each tooth (central incisors, lateral incisors and canines of the maxillary arch) on twice consecutively. If identical, the values will be recorded. Otherwise, new readings will be made until identical values are achieved. Only one result will be recorded for each tooth.
Measured: Before and immediately after bleaching as well as 48 horas and one week after bleaching.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2024
- Study start1 Nov 2024 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypersensitivityStudies 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
- Model description
- Split-mouth
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandra Kalil Bussadori, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06538129
- Sponsor's protocol ID
- Er:YAG Laser
- Status last verified
- Jul 2024
- First submitted
- 31 Jul 2024
- Last updated
- 5 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Er:YAG Laser for the Control of Hypersensitivity During Tooth Whitening With Hydrogen Peroxide: Protocol for a Split-Mouth Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06538129
- Acronym / sponsor ID
- Er:YAG Laser
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 5 Aug 2024 (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.
Introduction: Tooth whitening is an aesthetic procedure with rapid results that improves the self-esteem and self-image of patients. However, one of the side effects is dentinal hypersensitivity. The aim of the study is to assess the effectiveness of Er:YAG laser administered prior to bleaching with 35% hydrogen peroxide hypersensitivity.
Methods: The maxillary arch of participants 18 to 45 years of age will be treated using the split-mouth method. Grupo experimental: Hypersensitivity prevention protocol with Er:YAG laser followed by bleaching with 35% hydrogen peroxide; control group: hypersensitivity prevention protocol with neutral sodium fluoride for four minutes followed by bleaching with 35% hydrogen peroxide. Er:YAG laser (2940 nm) will be used with the following parameters: 0.15 W, 10 mJ, 15 Hz and SP mode (pulse duration: 300 µs), TIP: Cylindrical Quartz 1000/4, using the H14 handpiece (H14 for LightWalker AT; Fotona dd, Ljubljana, Slovenia). Each tooth (central incisor, lateral incisor and canine) will be irradiated twice for 10 s in an unfocused scanning motion in the cervical region at a working distance of 1 cm. The absolute risk and intensity of dentinal hypersensitivity during treatment will be assessed using the visual analogue scale. The change in color will be determined using an intraoral spectrophotometer in contact with the tooth. Assessments will be conducted before and after preventive treatment, immediately after treatment as well as 48 hours and one week after treatment. Different statistical tests will be used, with the significance level set at 5% (p ≤ 0.05).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Split-mouth
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Procedure: Hypersensitivity prevention protocol with Er:YAG laserThe participants will receive the hypersensitivity prevention protocol with Er:YAG laser in cervical region (central incisor, lateral incisor and canine). |
| Control Group | Experimental | Procedure: Hypersensitivity prevention protocol with neutral sodium fluoride gelThe participants will receive the hypersensitivity prevention protocol with neutral sodium fluoride gel for 4 minutes (central incisor, lateral incisor and canine). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- All anterior teeth present without caries or restorations;
- Absence of cervical lesions, dental pain and hypersensitivity prior to treatment;
- Not having previously undergone any tooth whitening procedure.
Key exclusion criteria (6 listed)
- Smokers;
- Pregnant or nursing women;
- Individuals with gingivitis or periodontitis, those with enamel cracks detected by the transillumination test;
- Those with enamel defects or stains caused by tetracycline;
- Those with systemic diseases;
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 |
|---|---|---|
| Hypersensitivity prevention protocol with Er:YAG laser1.Prophylaxis using airflow system with erythritol, potency 5, water regulator 5; 2.Initial assessment of hypersensitivity using visual analogue scale (VAS); 3.Color assessment (canines, central incisors and lateral incisors) with digital spectrophotometer (Vita Easyshade,); 4.Placement of dental dam followed by photoactivation with Valo cordless curing light 5.Hypersensitivity prevention protocol with Er:YAG laser in cervical region (central incisor, lateral incisor and canine); 6.Application of whitening gel (1 mm in thickness) with 35% hydrogen peroxide on maxillary arch (Clareador Whiteness HP; FGM), left to react for 15 minutes; 7.Removal of whitening gel; 8.Repeat procedures (steps 7 and 8); 9.Assessment of hypersensitivity immediately after hypersensitivity prevention procedure, immediately after bleaching, 48 after bleaching and one week after bleaching; 10.Color assessment with digital immediately after bleaching, 48 after bleaching and one week after bleaching. | Procedure or surgery | Experimental Group |
| Hypersensitivity prevention protocol with neutral sodium fluoride gel1.Prophylaxis using airflow system with erythritol, potency 5, water regulator 5; 2.Initial assessment of hypersensitivity using the VAS; 3.Color assessment (canines, central incisors and lateral incisors) with digital spectrophotometer (Vita Easyshade); 4.Placement of dental dam followed by photoactivation with Valo cordless; 5.Hypersensitivity prevention protocol with neutral sodium fluoride gel for 4 minutes (central incisor, lateral incisor and canine); 6.Application of whitening gel (1 mm in thickness) with 35% hydrogen peroxide on maxillary arch (Clareador Whiteness HP; FGM), left to react for 15 minutes; 7.Removal of whitening gel; 8.Repeat procedures (steps 7 and 8); 9.Assessment of hypersensitivity immediately after hypersensitivity prevention procedure, immediately after bleaching, 48 after bleaching and one week after bleaching; 10.Color assessment with digital spectrophotometer immediately after bleaching, 48 after bleaching and one week after bleaching. | Procedure or surgery | Control Group |
Primary outcome
Assessment of Dental Hypersensitivity
Time frame: At baseline as well as after the hypersensitivity prevention protocol, immediately after bleaching, 48 hours after bleaching and one week after bleaching.
The patients will be given a questionnaire with the VAS for the measurement of dental hypersensitivity. The patient will indicate the severity of tooth sensitivity by marking a vertical line along a 10-cm horizontal line with 0 (no sensitivity) printed at one end and 10 (severe sensitivity) at the other end for all teeth that receive treatment.
1 secondary outcome
Color assessment (instrumental method)
Time frame: Before and immediately after bleaching as well as 48 horas and one week after bleaching.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2024.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Hypersensitivity prevention protocol with Er:YAG laser and Hypersensitivity prevention protocol with neutral sodium fluoride gel in people with Hypersensitivity and Hypersensitivity, Immediate, run by University of Nove de Julho.
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 3 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: status not confirmed, as of the sponsor's last update on 5 Aug 2024. 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.
Are results available for this study?
Results are not available in the source record.
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?
Assessment of Dental Hypersensitivity (time frame: At baseline as well as after the hypersensitivity prevention protocol, immediately after bleaching, 48 hours after bleaching and one week after bleaching.). 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 5 Aug 2024; AzTrials last refreshed its copy on 8 Nov 2026.