Dentin HypersensitivityNCT06539286
Dentin Hypersensitivity - Varnish or Laser?
A study testing Laser Irradiation in people with Dentin Hypersensitivity, run by Sigmund Freud PrivatUniversitat.
Trial summary
Dentin hypersensitivity is a common condition described as a short and sharp pain caused by thermal, evaporative, tactile, osmotic, or chemical stimuli to exposed dentin that cannot be related to another defect or dental pathology. The variety of treatment options and products on the market might seem overwhelming. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Dentin Hypersensitivity
- What is being tested?
- Laser Irradiation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 2 Sep 2024to 14 Dec 2024
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- all genders
- 18-70 years
- good general health
- at least two hypersensitive teeth in either jaw
- initial VAS-score >3
Who cannot join
- Active carious lesions, insufficient restorations, enamel cracks, reversible pulpitis
- Active periodontal disease, periodontal surgery (in the last 6 months)
- Bleaching procedure in the last 3 months
- Analgetic use in the last 72 hours
- Pregnant/lactating women
About this study
Official title: Dentin Hypersensitivity - Varnish or Laser? A Randomized Clinical Study Comparing Three Wavelengths (2940 nm, 1064 nm and 970 nm) and the Desensitizer Gluma
Dentin hypersensitivity is a common condition described as a short and sharp pain caused by thermal, evaporative, tactile, osmotic, or chemical stimuli to exposed dentin that cannot be related to another defect or dental pathology. The variety of treatment options and products on the market might seem overwhelming. This study aims to show that laser treatments are efficient in reducing pain scores compared to a desensitizing agent (Gluma). 80 patients with at least two hypersensitive teeth will be enrolled in this study. Patients will be divided randomly into four groups (control group (Gluma), laser group 1 (2.94 µm wavelength), laser group 2 (1064 nm wavelength), laser group 3 (970 nm wavelength)). Visual Analog Scale will be measured before treatment, right after treatment, one week after treatment, one month after treatment, three months after treatment. Mixed Anova's and descriptive analysis will be used for statistical evaluation.
Read the detailed description
A total of 80 patients meeting the inclusion criteria will be included in this randomized clinical study. Participants will be randomly divided into four groups. Pain scores will be measured before treatment, right after treatment, 1 month after treatment and 3 months after treatment using the Visual Analog Scala (VAS). Patients will not know which treatment will be performed before nor will the patients from the laser groups know the wavelengths. Pain scores at check-up meetings will be collected by another doctor other than the one who will perform all laser treatments.
- Conditions
- Dentin Hypersensitivity
- Being tested
- Laser Irradiation
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser IrradiationDevice
Also called Desensitizing Agent Gluma
three different laser wavelengths will be used
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Desensitizing Agent Gluma Receives: Device: Laser Irradiation |
| 1. Laser Group | Active comparator | Er:YAG laser Receives: Device: Laser Irradiation |
| 2. Laser Group | Active comparator | Nd:YAG laser Receives: Device: Laser Irradiation |
| 3. Laser Group | Active comparator | 970 nm diode laser Receives: Device: Laser Irradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale changes
Patients will rate pain score with VAS. Pain scores will be evaluated before treatment, right after treatment, one week later, one month later and three months later
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start2 Sep 2024 (estimated)
- Primary completion14 Oct 2024 (estimated)
- Study completion14 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dentin 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sigmund Freud PrivatUniversitat
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06539286
- Sponsor's protocol ID
- DH
- Status last verified
- Aug 2024
- First submitted
- 1 Aug 2024
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dentin Hypersensitivity - Varnish or Laser? A Randomized Clinical Study Comparing Three Wavelengths (2940 nm, 1064 nm and 970 nm) and the Desensitizer Gluma
- ClinicalTrials.gov ID
- NCT06539286
- Acronym / sponsor ID
- DH
- Conditions
- Dentin Hypersensitivity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Sigmund Freud PrivatUniversitatUniversity, hospital or other
- Study start
- 2 Sep 2024 (estimated)
- Primary completion
- 14 Oct 2024 (estimated)
- Study completion
- 14 Dec 2024 (estimated)
- First posted
- 6 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.
Dentin hypersensitivity is a common condition described as a short and sharp pain caused by thermal, evaporative, tactile, osmotic, or chemical stimuli to exposed dentin that cannot be related to another defect or dental pathology. The variety of treatment options and products on the market might seem overwhelming. This study aims to show that laser treatments are efficient in reducing pain scores compared to a desensitizing agent (Gluma). 80 patients with at least two hypersensitive teeth will be enrolled in this study. Patients will be divided randomly into four groups (control group (Gluma), laser group 1 (2.94 µm wavelength), laser group 2 (1064 nm wavelength), laser group 3 (970 nm wavelength)). Visual Analog Scale will be measured before treatment, right after treatment, one week after treatment, one month after treatment, three months after treatment. Mixed Anova's and descriptive analysis will be used for statistical evaluation.
Detailed description
A total of 80 patients meeting the inclusion criteria will be included in this randomized clinical study. Participants will be randomly divided into four groups. Pain scores will be measured before treatment, right after treatment, 1 month after treatment and 3 months after treatment using the Visual Analog Scala (VAS). Patients will not know which treatment will be performed before nor will the patients from the laser groups know the wavelengths. Pain scores at check-up meetings will be collected by another doctor other than the one who will perform all laser treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Device: Laser IrradiationDesensitizing Agent Gluma |
| 1. Laser Group | Active comparator | Device: Laser IrradiationEr:YAG laser |
| 2. Laser Group | Active comparator | Device: Laser IrradiationNd:YAG laser |
| 3. Laser Group | Active comparator | Device: Laser Irradiation970 nm diode laser |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- all genders
- 18-70 years
- good general health
- at least two hypersensitive teeth in either jaw
- initial VAS-score >3
Key exclusion criteria (5 listed)
- Active carious lesions, insufficient restorations, enamel cracks, reversible pulpitis
- Active periodontal disease, periodontal surgery (in the last 6 months)
- Bleaching procedure in the last 3 months
- Analgetic use in the last 72 hours
- Pregnant/lactating women
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 |
|---|---|---|
| Laser IrradiationAlso: Desensitizing Agent Glumathree different laser wavelengths will be used | Device | 1. Laser Group, 2. Laser Group, 3. Laser Group, Control |
Primary outcome
Visual Analog Scale changes
Time frame: three months
Patients will rate pain score with VAS. Pain scores will be evaluated before treatment, right after treatment, one week later, one month later and three months later
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 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 Laser Irradiation in people with Dentin Hypersensitivity, run by Sigmund Freud PrivatUniversitat.
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 5 inclusion and 5 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 6 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?
Visual Analog Scale changes (time frame: three months). 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 6 Aug 2024.