Dentin HypersensitivityRctNCT06829277
Evaluation of Biomimetic Mineralization Plus Soft Laser Irradiation in Dentin Hypersensitivity Management
A study testing Sodium fluoride varnish, Curodont De Senz and Curodont De Senz plus laser irradiation in people with Dentin Hypersensitivity, run by MTI University at 1 site in Egypt.
Trial summary
Randomized clinical trial to investigate the efficacy of diode laser , Biomimetic mineralization desensitizing agents Curodont D'Senz (CS) gel both in combination and alone, and the efficacy of bifluoride 10 (5 % sodium fluoride) varnish alone in cervical dentin hypersensitivity patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dentin Hypersensitivity
- What is being tested?
- Sodium fluoride varnish, Curodont De Senz and Curodont De Senz plus laser irradiation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2024to 30 Jan 2025
- 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
- Age from 18-60 years old.
- Non-smokers.
- Disease-free patients.
- Good oral hygiene.
- Having at least one teeth suffering from cervical dentin hypersensitivity with VAS pain score ≥5
- Recording pain to thermal, mechanical or tactile stimuli.
- Acceptance to participate in the study
Who cannot join
- Smoking and bad oral hygiene.
- Presence of carious lesions, restorations or fracture in the test area.
- Presence of painful pathology restored less than three months in the test area.
- Using any desen¬sitizing agents.
- Undergo any peri¬odontal surgery in the last 6 months.
- Drug abusers.
- Administration of potent analgesics or anti-inflammatory drugs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Biomimetic Mineralization Approach Plus Soft Laser Irradiation in Management of Dentin Hypersensitivity: A Randomized Clinical Trial
Randomized clinical trial to investigate the efficacy of diode laser , Biomimetic mineralization desensitizing agents Curodont D'Senz (CS) gel both in combination and alone, and the efficacy of bifluoride 10 (5 % sodium fluoride) varnish alone in cervical dentin hypersensitivity patients. Also, to assess the duration of sensitivity relief immediately after 15 minutes of application, after 2 weeks, after 1 month and 3 months , the null hypothesis that there will be no difference between the treatment groups in different times.
Read the detailed description
Current research focuses on increasing the mineral density of the dentin surface making it possible to improve its resistance to wear by both acid erosion and abrasion and plugging and sealing open tubules with a calcium and phosphate containing dentin-like substance, which would block diffusion through the tubules into the dentin sub-surface, thereby increasing acid resistance. Self-assembling peptide matrix (P11-4) supplied commercially as Curodont D'Senz (CS) gel (Credentis AG, Windisch, Switzerland) is based on the nanofiber technology that enhances biomimetic repair and the remineralization of dental tissues. Self-assembling peptide matrix hydrogel revealed more reduction of the opened dentinal tubules in comparison to other selected desensitizing toothpaste.lasers have been recently been introduced as another possibility for in-office treatment of DH and may open up new horizons in the treatment of dentin hypersensitivity. Of interest is the fact that the laser irradiation can augment the effect of the desensitizer for a longer duration than when they are used alone. They hypothesized that laser favor the durability of the desensitizer for extended time. Some studies recommend desensitizing agent to remain above tooth surface for one minute before laser irradiation.
- Conditions
- Dentin Hypersensitivity
- Being tested
- Sodium fluoride varnish, Curodont De Senz, Curodont De Senz plus laser irradiation, Laser irradiation
- Keywords
- Curodont de senz, Laser, Fluoride varnish
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium fluoride varnishCombination product
Sodium fluoride varnish
Curodont De SenzOther
Curodont De Senz
Curodont De Senz plus laser irradiationCombination product
Curodont De Senz plus laser irradiation
Laser irradiationDevice
Laser irradiation
| Study group | Role | What they receive |
|---|---|---|
| Sodium fluoride varnish | Active comparator | Sodium fluoride varnish Receives: Combination Product: Sodium fluoride varnish |
| Curodont De senz | Experimental | Curodont De Senz Receives: Other: Curodont De Senz |
| Curodont De Senz plus laser irradiation | Experimental | Curodont De Senz plus laser irradiation Receives: Combination Product: Curodont De Senz plus laser irradiation |
| Laser irradiation | Experimental | Laser irradiation Receives: Device: Laser irradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dentin hypersensitivity
Visual Analogue Scale (VAS) will be used by which 0 is no pain and 10 is severe pain. Pictures are added to the same, as well as colors to guide the patient during selection of pain severity.
The VAS scale (0-10) is the recommended tool used to evaluate pain of dentin hypersensitivity, and it is the most commonly used in most of the clinical trials. The patient should point out the degree of sensitivity on the VAS scale (0-chart the degree of pain. (VAS >4). A plastic card with figures of facial expressions expressing the degree of pain, color-coded, and numbers guided will be used to ease the process of figuring out the degree of pain. These cards are also useful in standardizing the assessment method for the patient throughout the study and taking records without any verbal or emotional guidance from the assessors.
Measured: Baseline - 15 minutes- 2 weeks - 1 month - 3 months
A- Tactile test
By explorer
Measured: Baseline - 15 minutes- 2 weeks - 1 month - 3 months
B- Evaporative test
By air syringe
Measured: Baseline - 15 minutes - 2 weeks- 1 month - 3 months
C- Thermal Test
By refreigent spray
Measured: Baseline - 15 minutes - 2 weeks- 1 month - 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start1 Nov 2024
- Primary completion30 Jan 2025
- Study completion30 Jan 2025
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
- Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- MTI University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mennatallah Atef Aboulnaga, MTI University
- Investigators
- Aalaa M nabil, Lecturer, Study chair, MTI UniversityAhmed M Sayed, Assis. prof., Study director, MTI University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06829277
- Sponsor's protocol ID
- Mti-2025-11
- Acronym
- Rct
- Status last verified
- Jul 2025
- First submitted
- 11 Feb 2025
- Last updated
- 29 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I will not publish in ICMJE
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Biomimetic Mineralization Approach Plus Soft Laser Irradiation in Management of Dentin Hypersensitivity: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06829277
- Acronym / sponsor ID
- Rct / Mti-2025-11
- Conditions
- Dentin Hypersensitivity
- Keywords
- Curodont de senz, Laser, Fluoride varnish
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- MTI UniversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 30 Jan 2025 (actual)
- Study completion
- 30 Jan 2025 (actual)
- First posted
- 17 Feb 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.
Randomized clinical trial to investigate the efficacy of diode laser , Biomimetic mineralization desensitizing agents Curodont D'Senz (CS) gel both in combination and alone, and the efficacy of bifluoride 10 (5 % sodium fluoride) varnish alone in cervical dentin hypersensitivity patients. Also, to assess the duration of sensitivity relief immediately after 15 minutes of application, after 2 weeks, after 1 month and 3 months , the null hypothesis that there will be no difference between the treatment groups in different times.
Detailed description
Current research focuses on increasing the mineral density of the dentin surface making it possible to improve its resistance to wear by both acid erosion and abrasion and plugging and sealing open tubules with a calcium and phosphate containing dentin-like substance, which would block diffusion through the tubules into the dentin sub-surface, thereby increasing acid resistance. Self-assembling peptide matrix (P11-4) supplied commercially as Curodont D'Senz (CS) gel (Credentis AG, Windisch, Switzerland) is based on the nanofiber technology that enhances biomimetic repair and the remineralization of dental tissues. Self-assembling peptide matrix hydrogel revealed more reduction of the opened dentinal tubules in comparison to other selected desensitizing toothpaste.lasers have been recently been introduced as another possibility for in-office treatment of DH and may open up new horizons in the treatment of dentin hypersensitivity. Of interest is the fact that the laser irradiation can augment the effect of the desensitizer for a longer duration than when they are used alone. They hypothesized that laser favor the durability of the desensitizer for extended time. Some studies recommend desensitizing agent to remain above tooth surface for one minute before laser irradiation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sodium fluoride varnish | Active comparator | Combination Product: Sodium fluoride varnishSodium fluoride varnish |
| Curodont De senz | Experimental | Other: Curodont De SenzCurodont De Senz |
| Curodont De Senz plus laser irradiation | Experimental | Combination Product: Curodont De Senz plus laser irradiationCurodont De Senz plus laser irradiation |
| Laser irradiation | Experimental | Device: Laser irradiationLaser irradiation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Age from 18-60 years old.
- Non-smokers.
- Disease-free patients.
- Good oral hygiene.
- Having at least one teeth suffering from cervical dentin hypersensitivity with VAS pain score ≥5
Key exclusion criteria (7 listed)
- Smoking and bad oral hygiene.
- Presence of carious lesions, restorations or fracture in the test area.
- Presence of painful pathology restored less than three months in the test area.
- Using any desen¬sitizing agents.
- Undergo any peri¬odontal surgery in the last 6 months.
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 |
|---|---|---|
| Sodium fluoride varnishSodium fluoride varnish | Combination product | Sodium fluoride varnish |
| Curodont De SenzCurodont De Senz | Other | Curodont De senz |
| Curodont De Senz plus laser irradiationCurodont De Senz plus laser irradiation | Combination product | Curodont De Senz plus laser irradiation |
| Laser irradiationLaser irradiation | Device | Laser irradiation |
Primary outcome
Dentin hypersensitivity
Time frame: Baseline - 15 minutes- 2 weeks - 1 month - 3 months
Visual Analogue Scale (VAS) will be used by which 0 is no pain and 10 is severe pain. Pictures are added to the same, as well as colors to guide the patient during selection of pain severity. The VAS scale (0-10) is the recommended tool used to evaluate pain of dentin hypersensitivity, and it is the most commonly used in most of the clinical trials. The patient should point out the degree of sensitivity on the VAS scale (0-chart the degree of pain. (VAS >4). A plastic card with figures of facial expressions expressing the degree of pain, color-coded, and numbers guided will be used to ease the process of figuring out the degree of pain. These cards are also useful in standardizing the assessment method for the patient throughout the study and taking records without any verbal or emotional guidance from the assessors.
A- Tactile test
Time frame: Baseline - 15 minutes- 2 weeks - 1 month - 3 months
By explorer
B- Evaporative test
Time frame: Baseline - 15 minutes - 2 weeks- 1 month - 3 months
By air syringe
C- Thermal Test
Time frame: Baseline - 15 minutes - 2 weeks- 1 month - 3 months
By refreigent spray
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 29 Jul 2025.
- Individual participant dataSharing planned: No. I will not publish in ICMJE
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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.
Aalaa M nabil, Lecturer study chair
MTI University
Ahmed M Sayed, Assis. prof. study director
MTI University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sodium fluoride varnish, Curodont De Senz and Curodont De Senz plus laser irradiation in people with Dentin Hypersensitivity, run by MTI University at 1 site in Egypt.
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 29 Jul 2025. 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 Egypt. 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?
Dentin hypersensitivity (time frame: Baseline - 15 minutes- 2 weeks - 1 month - 3 months). The study lists 4 primary outcomes in all. 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 29 Jul 2025.