Hypersensitivity DentinNCT06746558
Potassium Nitrate Gel and Diode Laser for Dentinal Hypersensitivity
A study testing Potassium Nitrate Gel and Diode Laser Therapy and Potassium Nitrate Gel Alone in people with Hypersensitivity Dentin, run by University of Modena and Reggio Emilia at 1 site in Italy.
Trial summary
The goal of this randomized clinical trial is to evaluate whether combining a potassium nitrate gel with diode laser therapy is more effective in treating dentinal hypersensitivity compared to using the gel alone. The study involves adult participants with at least two teeth affected by dentinal hypersensitivity. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hypersensitivity Dentin
- What is being tested?
- Potassium Nitrate Gel and Diode Laser Therapy and Potassium Nitrate Gel Alone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteItaly
- Study dates
- 7 Jan 2023to 31 Oct 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adults aged 18 years or older.
- At least two teeth affected by dentinal hypersensitivity.
- Good standard of home oral hygiene.
Who cannot join
- Use of pain relievers.
- Ongoing orthodontic treatment.
- Non-vital teeth or teeth with restorative materials.
- Pregnant or breastfeeding women.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Università degli Studi di Pavia, Department of Orthodontics
Pavia, PV
About this study
Official title: Clinical Evaluation Of The Combined Effect Of A Potassium Nitrate Gel And Diode Laser In The Treatment Of Dentinal Hypersensitivity: A Randomized Clinical Trial
The goal of this randomized clinical trial is to evaluate whether combining a potassium nitrate gel with diode laser therapy is more effective in treating dentinal hypersensitivity compared to using the gel alone. The study involves adult participants with at least two teeth affected by dentinal hypersensitivity. The main questions it aims to answer are:
Does the combined use of potassium nitrate gel and diode laser therapy reduce dentinal hypersensitivity more effectively than gel alone? How does this combined treatment impact sensitivity-related quality of life over time? Researchers will compare the outcomes between the two groups (combined therapy versus gel alone) to determine the effectiveness of the combined treatment.
Read more
Participants will:
Undergo assessments of dentinal hypersensitivity using the Shiff Air Index (SAI) and Visual Analog Scale (VAS) at baseline and at follow-ups (1 month, 3 months, and 6 months post-treatment).
Complete a questionnaire to evaluate the impact of dentinal hypersensitivity on daily life at baseline and after 6 months.
- Conditions
- Hypersensitivity Dentin
- Being tested
- Potassium Nitrate Gel and Diode Laser Therapy, Potassium Nitrate Gel Alone
- Keywords
- Dentinal hypersensitivity, potassium nitrate, diode laser therapy, desensitization, dental pain management
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Potassium Nitrate Gel and Diode Laser TherapyCombination product
Participants in the experimental group receive treatment combining a desensitizing gel containing 5% potassium nitrate (Emoform Actisens) applied to affected teeth and diode laser therapy (980 nm). The laser is used with specific power settings (0.3W, 0.5W, 0.7W) for 20 seconds at each setting, followed by a second application of the gel and irradiation. The treatment aims to reduce dentinal hypersensitivity by occluding dentinal tubules and altering neural responses.
Potassium Nitrate Gel AloneDrug
Participants in the control group receive treatment with a desensitizing gel containing 5% potassium nitrate (Emoform Actisens) applied to the teeth. The gel is applied twice using a microbrush in a rubbing motion for 2 minutes each time. No diode laser therapy is administered. This intervention aims to evaluate the standalone efficacy of the gel in reducing dentinal hypersensitivity.
| Study group | Role | What they receive |
|---|---|---|
| Potassium Nitrate Gel with Diode Laser Therapy | Experimental | Not described Receives: Combination Product: Potassium Nitrate Gel and Diode Laser Therapy |
| Potassium Nitrate Gel Alone | Active comparator | Not described Receives: Drug: Potassium Nitrate Gel Alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Dentinal Hypersensitivity (Shiff Air Index)
The Shiff Air Index measures sensitivity by applying a standardized air stimulus to the dental surface. Patients report their sensitivity level on a scale from 0 to 3, where 0 indicates no sensitivity and 3 indicates severe sensitivity. The scores are interpreted to assess the degree of dentinal hypersensitivity.
Measured: Baseline (T0), immediately post-treatment (T1), 1 month (T2), 3 months (T3), and 6 months (T4)
Reduction in Dentinal Hypersensitivity (Visual Analog Scale)
The Visual Analog Scale (VAS) measures the intensity of pain by asking participants to rate their pain on a 10-point scale, where 0 represents no pain and 10 represents the worst pain imaginable. Participants will receive guidance to mark their pain level on the scale based on their subjective experience, providing a standardized measure of dentinal hypersensitivity.
Measured: Baseline (T0), immediately post-treatment (T1), 1 month (T2), 3 months (T3), and 6 months (T4).
Secondary outcomes (1)
Changes in Quality of Life (Dentine Hypersensitivity Experience Questionnaire)
The Dentine Hypersensitivity Experience Questionnaire (DHEQ) is a validated tool designed to assess the impact of dentinal hypersensitivity on daily activities, emotions, and overall quality of life. It consists of 15 questions rated on a 1 to 7 scale, where higher scores indicate a greater negative impact on quality of life.
Measured: Baseline (T0) and 6 months (T4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2024
- Study start7 Jan 2023
- Primary completion31 Oct 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypersensitivity DentinStudies 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Modena and Reggio Emilia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pavia, University of Genova
- Responsible party
- Principal investigator, Alessandro Bruni, University of Modena and Reggio Emilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06746558
- Sponsor's protocol ID
- 76 2022-0316
- Status last verified
- Dec 2024
- First submitted
- 17 Dec 2024
- Last updated
- 24 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Simoes TM, Melo KC, Fernandes-Neto JA, Batista AL, da Silva MG, Ferreira AC, de Sousa JA, Catao MV. Use of high- and low-intensity lasers in the treatment of dentin hypersensitivity: A literature review. J Clin Exp Dent. 2021 Apr 1;13(4):e412-e417. doi: 10.4317/jced.57783. eCollection 2021 Apr.
PubMed 33841742
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation Of The Combined Effect Of A Potassium Nitrate Gel And Diode Laser In The Treatment Of Dentinal Hypersensitivity: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06746558
- Acronym / sponsor ID
- 76 2022-0316
- Conditions
- Hypersensitivity Dentin
- Keywords
- Dentinal hypersensitivity, potassium nitrate, diode laser therapy, desensitization, dental pain management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of Modena and Reggio EmiliaUniversity, hospital or other
- Collaborators
- University of Pavia, University of Genova
- Study start
- 7 Jan 2023 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 24 Dec 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.
The goal of this randomized clinical trial is to evaluate whether combining a potassium nitrate gel with diode laser therapy is more effective in treating dentinal hypersensitivity compared to using the gel alone. The study involves adult participants with at least two teeth affected by dentinal hypersensitivity. The main questions it aims to answer are:
Does the combined use of potassium nitrate gel and diode laser therapy reduce dentinal hypersensitivity more effectively than gel alone? How does this combined treatment impact sensitivity-related quality of life over time? Researchers will compare the outcomes between the two groups (combined therapy versus gel alone) to determine the effectiveness of the combined treatment.
Participants will:
Undergo assessments of dentinal hypersensitivity using the Shiff Air Index (SAI) and Visual Analog Scale (VAS) at baseline and at follow-ups (1 month, 3 months, and 6 months post-treatment).
Complete a questionnaire to evaluate the impact of dentinal hypersensitivity on daily life at baseline and after 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Potassium Nitrate Gel with Diode Laser Therapy | Experimental | Combination Product: Potassium Nitrate Gel and Diode Laser Therapy |
| Potassium Nitrate Gel Alone | Active comparator | Drug: Potassium Nitrate Gel Alone |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged 18 years or older.
- At least two teeth affected by dentinal hypersensitivity.
- Good standard of home oral hygiene.
Key exclusion criteria (4 listed)
- Use of pain relievers.
- Ongoing orthodontic treatment.
- Non-vital teeth or teeth with restorative materials.
- Pregnant or breastfeeding 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 |
|---|---|---|
| Potassium Nitrate Gel and Diode Laser TherapyParticipants in the experimental group receive treatment combining a desensitizing gel containing 5% potassium nitrate (Emoform Actisens) applied to affected teeth and diode laser therapy (980 nm). The laser is used with specific power settings (0.3W, 0.5W, 0.7W) for 20 seconds at each setting, followed by a second application of the gel and irradiation. The treatment aims to reduce dentinal hypersensitivity by occluding dentinal tubules and altering neural responses. | Combination product | Potassium Nitrate Gel with Diode Laser Therapy |
| Potassium Nitrate Gel AloneParticipants in the control group receive treatment with a desensitizing gel containing 5% potassium nitrate (Emoform Actisens) applied to the teeth. The gel is applied twice using a microbrush in a rubbing motion for 2 minutes each time. No diode laser therapy is administered. This intervention aims to evaluate the standalone efficacy of the gel in reducing dentinal hypersensitivity. | Drug | Potassium Nitrate Gel Alone |
Primary outcome
Reduction in Dentinal Hypersensitivity (Shiff Air Index)
Time frame: Baseline (T0), immediately post-treatment (T1), 1 month (T2), 3 months (T3), and 6 months (T4)
The Shiff Air Index measures sensitivity by applying a standardized air stimulus to the dental surface. Patients report their sensitivity level on a scale from 0 to 3, where 0 indicates no sensitivity and 3 indicates severe sensitivity. The scores are interpreted to assess the degree of dentinal hypersensitivity.
Reduction in Dentinal Hypersensitivity (Visual Analog Scale)
Time frame: Baseline (T0), immediately post-treatment (T1), 1 month (T2), 3 months (T3), and 6 months (T4).
The Visual Analog Scale (VAS) measures the intensity of pain by asking participants to rate their pain on a 10-point scale, where 0 represents no pain and 10 represents the worst pain imaginable. Participants will receive guidance to mark their pain level on the scale based on their subjective experience, providing a standardized measure of dentinal hypersensitivity.
1 secondary outcome
Changes in Quality of Life (Dentine Hypersensitivity Experience Questionnaire)
Time frame: Baseline (T0) and 6 months (T4)
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 24 Dec 2024.
- Results publication: PubMed 33841742Simoes TM, Melo KC, Fernandes-Neto JA, Batista AL, da Silva MG, Ferreira AC, de Sousa JA, Catao MV. Use of high- and low-intensity lasers in the treatment of dentin hypersensitivity: A literature review. J Clin Exp Dent. 2021 Apr 1;13(4):e412-e417. doi: 10.4317/jced.57783. eCollection 2021 Apr.
- Related InfoLink provided by the sponsor.
- 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 and Diode Laser Therapy and Potassium Nitrate Gel Alone in people with Hypersensitivity Dentin, run by University of Modena and Reggio Emilia at 1 site in Italy.
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 4 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 24 Dec 2024. 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 Italy. 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.
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?
Reduction in Dentinal Hypersensitivity (Shiff Air Index) (time frame: Baseline (T0), immediately post-treatment (T1), 1 month (T2), 3 months (T3), and 6 months (T4)). 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?
On the ClinicalTrials.gov record for NCT06746558, which also lists 1 linked publication.
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 24 Dec 2024.