DentistryPotassiumNitraNCT06923904
Potassium Nitrate Gel and Diode Laser in the Treatment of Dentinal Hypersensitivity
A study testing Trial group, treated with a 980 nm diode laser and desensitizing topical gel in people with Dentistry and Desensitization, run by University of Pavia.
Trial summary
Our aim will be to evaluate the actual efficacy of diode lasers in laser desensitization by comparing the topical gel Emoform Actisens, containing 5% potassium nitrate, alone and in combination with a diode laser. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dentistry, Desensitization
- What is being tested?
- Trial group, treated with a 980 nm diode laser and desensitizing topical gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2025to 30 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
The inclusion criteria will be as follows: (a) a good standard of home oral hygiene and (b) at least two teeth affected by DH.
The exclusion criteria will be: (a) individuals taking pain relievers; (b) individuals undergoing orthodontic treatment; (c) non-vital teeth; (d) teeth with restorative materials; and (e) pregnant or breastfeeding women
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Our aim will be to evaluate the actual efficacy of diode lasers in laser desensitization by comparing the topical gel Emoform Actisens, containing 5% potassium nitrate, alone and in combination with a diode laser. Dental hypersensitivity (DH) will be assessed pre- (T0) and post-treatment (T1) and at 1 month (T2), 3 months (T3), and 6 months (T4).
Read the detailed description
This will be a randomized clinical trial (RCT) with a split-mouth design, involving 12 subjects, with two parallel groups. The dental elements will be divided into the Trial group, treated with a 980 nm diode laser and desensitizing topical gel, and the Control group, treated only with the same gel. DH will be assessed using the Shiff Air Index (SAI) and Visual Analog Scale (VAS).
- Conditions
- Dentistry, Desensitization
- Being tested
- Trial group, treated with a 980 nm diode laser and desensitizing topical gel
- Keywords
- desensitizing treatment, diode laser, oral hygiene, dental sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trial group, treated with a 980 nm diode laser and desensitizing topical gelOther
The study aims to evaluate the actual efficacy of diode lasers in laser desensitization by comparing the topical gel Emoform Actisens, containing 5% potassium nitrate, alone and in combination with a diode laser.
| Study group | Role | What they receive |
|---|---|---|
| Patients with dental sensitivity | Experimental | With a split-mouth design the dental elements will be divided into the Trial group, treated with a 980 nm diode laser and desensitizing topical gel, and the Control group, treated only with the same gel. Receives: Other: Trial group, treated with a 980 nm diode laser and desensitizing topical gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
degree of dentin hypersensitivity
assessed using the Dentine Hypersensitivity Experience Questionnaire (DHEQ). The DHEQ is a validated self-report tool designed to assess the impact of dentine hy-persensitivity on a patient's daily life, including the intensity and frequency of symptoms as well as the emotional, social, and practical effects on daily activities such as eating, drinking, and oral hygiene practices. The DHEQ consists of 15 questions, with responses rated on a numerical scale from 1 ("strongly disagree") to 7 ("strongly agree"). The final score is calculated out of a total of 105 points, with higher scores indicating a greater im-pact of dentin sensitivity on daily life.
Measured: From enrollment to 6 months after desensitizing procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2025
- Study start15 Apr 2025 (estimated)
- Primary completion30 Oct 2025 (estimated)
- Study completion30 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DentistryStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This will be a randomized clinical trial (RCT) with a split-mouth design
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Scribante, University of Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06923904
- Sponsor's protocol ID
- PotassiumNitrateLaser
- Acronym
- PotassiumNitra
- Status last verified
- Apr 2025
- First submitted
- 14 Mar 2025
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be publish as aggregate data with descriptive and inferential statistics
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Potassium Nitrate Gel and Diode Laser in the Treatment of Dentinal Hypersensitivity
- ClinicalTrials.gov ID
- NCT06923904
- Acronym / sponsor ID
- PotassiumNitra / PotassiumNitrateLaser
- Conditions
- Dentistry, Desensitization
- Keywords
- desensitizing treatment, diode laser, oral hygiene, dental sensitivity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Study start
- 15 Apr 2025 (estimated)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 11 Apr 2025 (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.
Our aim will be to evaluate the actual efficacy of diode lasers in laser desensitization by comparing the topical gel Emoform Actisens, containing 5% potassium nitrate, alone and in combination with a diode laser. Dental hypersensitivity (DH) will be assessed pre- (T0) and post-treatment (T1) and at 1 month (T2), 3 months (T3), and 6 months (T4).
Detailed description
This will be a randomized clinical trial (RCT) with a split-mouth design, involving 12 subjects, with two parallel groups. The dental elements will be divided into the Trial group, treated with a 980 nm diode laser and desensitizing topical gel, and the Control group, treated only with the same gel. DH will be assessed using the Shiff Air Index (SAI) and Visual Analog Scale (VAS).
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This will be a randomized clinical trial (RCT) with a split-mouth design
| Arm | Type | Receives |
|---|---|---|
| Patients with dental sensitivity | Experimental | Other: Trial group, treated with a 980 nm diode laser and desensitizing topical gelWith a split-mouth design the dental elements will be divided into the Trial group, treated with a 980 nm diode laser and desensitizing topical gel, and the Control group, treated only with the same gel. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Trial group, treated with a 980 nm diode laser and desensitizing topical gelThe study aims to evaluate the actual efficacy of diode lasers in laser desensitization by comparing the topical gel Emoform Actisens, containing 5% potassium nitrate, alone and in combination with a diode laser. | Other | Patients with dental sensitivity |
Primary outcome
degree of dentin hypersensitivity
Time frame: From enrollment to 6 months after desensitizing procedure
assessed using the Dentine Hypersensitivity Experience Questionnaire (DHEQ). The DHEQ is a validated self-report tool designed to assess the impact of dentine hy-persensitivity on a patient's daily life, including the intensity and frequency of symptoms as well as the emotional, social, and practical effects on daily activities such as eating, drinking, and oral hygiene practices. The DHEQ consists of 15 questions, with responses rated on a numerical scale from 1 ("strongly disagree") to 7 ("strongly agree"). The final score is calculated out of a total of 105 points, with higher scores indicating a greater im-pact of dentin sensitivity on daily life.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
- Individual participant dataSharing planned: No. Data will be publish as aggregate data with descriptive and inferential statistics
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Trial group, treated with a 980 nm diode laser and desensitizing topical gel in people with Dentistry and Desensitization, run by University of Pavia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: opening soon, as of the sponsor's last update on 11 Apr 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrea Scribante, DDS PhD MHA MSc (+39382516209, andrea.scribante@unipv.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
degree of dentin hypersensitivity (time frame: From enrollment to 6 months after desensitizing procedure). 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 11 Apr 2025.