Dentin Hypersensitivity, Non-carious Cervical LesionsNCT07418788
Polymeric Nano Calcium Fluoride Varnish, Diode Laser, and Their Combination for Dentin Hypersensitivity
A study testing Olinano seal, Diode Laser and Olinano seal and Diode Laser in people with Dentin Hypersensitivity, Non-carious Cervical Lesions and Gingival Recession Localized Moderate, run by Faculty of Dental Medicine for Girls at 1 site in Egypt.
Trial summary
The aim of the study is to assess the effect of polymeric nano calcium fluoride Varnish (Oli-NANO seal), 976 nm diode laser solely and combination of both therapies in the treatment of dentin hypersensitivity Read more about this study
- Who is it for?
- Ages 30 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Dentin Hypersensitivity, Non-carious Cervical Lesions, Gingival Recession Localized Moderate
- What is being tested?
- Olinano seal, Diode Laser and Olinano seal and Diode Laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 15 May 2025to 16 Jul 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 30 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Medically free
- Non-smokers
- Co-operative patients who will be interested in participating in the study and willing to sign the informed consent.
- Availability of patients for 1 year
Who cannot join
- Patients currently using analgesic, anti-inflammatory medications, sedatives, tranquilizers, anticonvulsants, or any other medications that could potentially alter pain perception.
- Patients undergoing orthodontic treatment.
- Patients using desensitizing toothpaste
- Patients receiving dentin hypersensitivity (DH) treatment
- Pregnant or lactating women
- Patients have high consumption of sour and acidic food
- Patients who had undergone professional desensitizing therapy during the previous 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Polymeric Nano Calcium Fluoride Varnish, Diode Laser Individually and in Combination in the Treatment of Dentin Hypersensitivity.
The aim of the study is to assess the effect of polymeric nano calcium fluoride Varnish (Oli-NANO seal), 976 nm diode laser solely and combination of both therapies in the treatment of dentin hypersensitivity
- Conditions
- Dentin Hypersensitivity, Non-carious Cervical Lesions, Gingival Recession Localized Moderate
- Being tested
- Olinano seal, Diode Laser, Olinano seal and Diode Laser
- Keywords
- Dentin Hypersensitivity, Laser, Olinano Seal, Dual Treatment
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olinano sealOther
The OliNANO seal is "varnish-like" shield which is based on nanotechnology that allows an optimum adhesion to enamel and dentin, it could be used as an effective desensitizing agent by forming a protective layer that occludes the dentinal tubules which can be effective for a year as mentioned by the manufacturer. Polymeric nano calcium fluoride varnish consists of four main components, silicone polymer, NANO-fluorapatite, nano-calcium fluoride and amine fluoride (Olaflur)
Diode LaserDevice
increase in the metabolic activity of odontoblasts. Thus, obliteration of the dentinal tubules and formation of tertiary dentin.
Olinano seal and Diode LaserOther
Combined methods have been also evaluated in some previous studies. It showed more effect in reducing Dentin hypersensitivity than using every treatment solely
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (OliNano Seal) | Experimental | OliNano Seal (polymeric nano calcium fluoride containing varnish) Receives: Other: Olinano seal |
| Group 2 (Diode laser) | Active comparator | Diode laser Receives: Device: Diode Laser |
| Group 3 (OliNano Seal and Diode laser) | Experimental | OliNano Seal and Diode laser Receives: Other: Olinano seal and Diode Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain severity
The pain will be assessed using the (VAS) scale. The VAS is a scale that allows the patient to self-assess the pain felt by means of a line in which the patient marks the pain level "no pain" to the "maximum pain". 0: low pain, 1 - 3: moderate pain: 4 - 6, intense pain: 7 - 9, extremely intense pain: 10
Measured: Before the treatment (Baseline), after the first session (T1), second session (T2) will be done after a week from the first session, after 3 months (T3), 6 months (T6), 9 months (T9) and 12 months (T12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start15 May 2025
- Primary completion10 Jul 2025
- Study completion16 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dentin Hypersensitivity, Non-carious Cervical LesionsStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculty of Dental Medicine for Girls
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Basant Bahaa El Din Ibrahim, Misr International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07418788
- Sponsor's protocol ID
- P-OP-24-08
- Status last verified
- Sep 2026
- First submitted
- 20 Jan 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Polymeric Nano Calcium Fluoride Varnish, Diode Laser Individually and in Combination in the Treatment of Dentin Hypersensitivity.
- ClinicalTrials.gov ID
- NCT07418788
- Acronym / sponsor ID
- P-OP-24-08
- Conditions
- Dentin Hypersensitivity, Non-carious Cervical Lesions, Gingival Recession Localized Moderate
- Keywords
- Dentin Hypersensitivity, Laser, Olinano Seal, Dual Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Faculty of Dental Medicine for GirlsOther government
- Study start
- 15 May 2025 (actual)
- Primary completion
- 10 Jul 2025 (actual)
- Study completion
- 16 Jul 2026 (actual)
- First posted
- 18 Feb 2026 (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 aim of the study is to assess the effect of polymeric nano calcium fluoride Varnish (Oli-NANO seal), 976 nm diode laser solely and combination of both therapies in the treatment of dentin hypersensitivity
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 (OliNano Seal) | Experimental | Other: Olinano sealOliNano Seal (polymeric nano calcium fluoride containing varnish) |
| Group 2 (Diode laser) | Active comparator | Device: Diode LaserDiode laser |
| Group 3 (OliNano Seal and Diode laser) | Experimental | Other: Olinano seal and Diode LaserOliNano Seal and Diode laser |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Medically free
Key exclusion criteria (7 listed)
- Patients currently using analgesic, anti-inflammatory medications, sedatives, tranquilizers, anticonvulsants, or any other medications that could potentially alter pain perception.
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 |
|---|---|---|
| Olinano sealThe OliNANO seal is "varnish-like" shield which is based on nanotechnology that allows an optimum adhesion to enamel and dentin, it could be used as an effective desensitizing agent by forming a protective layer that occludes the dentinal tubules which can be effective for a year as mentioned by the manufacturer. Polymeric nano calcium fluoride varnish consists of four main components, silicone polymer, NANO-fluorapatite, nano-calcium fluoride and amine fluoride (Olaflur) | Other | Group 1 (OliNano Seal) |
| Diode Laserincrease in the metabolic activity of odontoblasts. Thus, obliteration of the dentinal tubules and formation of tertiary dentin. | Device | Group 2 (Diode laser) |
| Olinano seal and Diode LaserCombined methods have been also evaluated in some previous studies. It showed more effect in reducing Dentin hypersensitivity than using every treatment solely | Other | Group 3 (OliNano Seal and Diode laser) |
Primary outcome
Pain severity
Time frame: Before the treatment (Baseline), after the first session (T1), second session (T2) will be done after a week from the first session, after 3 months (T3), 6 months (T6), 9 months (T9) and 12 months (T12)
The pain will be assessed using the (VAS) scale. The VAS is a scale that allows the patient to self-assess the pain felt by means of a line in which the patient marks the pain level "no pain" to the "maximum pain". 0: low pain, 1 - 3: moderate pain: 4 - 6, intense pain: 7 - 9, extremely intense pain: 10
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 18 Sep 2026.
- Individual participant dataSharing planned: Yes
Related trials for Dentin Hypersensitivity, Non-carious Cervical Lesions
Not yet recruiting
Evaluation of Different Non-Invasive Methods in the Treatment of Dentin Hypersensitivity Associated With Non-Carious Cervical Lesions: A Split-Mouth Clinical Study
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Not yet recruiting
Diode Laser Plus CPP-ACPF vs CPP-ACPF Alone for Dentin Hypersensitivity
Dentin Hypersensitivity, Tooth Hypersensitivity
Active, not recruitingPhase 2/3
Effectiveness of Resin-Based Desensitizer and Laser, Compared to Fluoride Varnish in Management of Dentine Hypersensitivity in Non-carious Cervical Lesions
Dentin Hypersensitivity, Non-carious Cervical Lesions, Bioactive Glass Air Polishing, S-PRG, Dentin Hypersensitivity
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 Olinano seal, Diode Laser and Olinano seal and Diode Laser in people with Dentin Hypersensitivity, Non-carious Cervical Lesions and Gingival Recession Localized Moderate, run by Faculty of Dental Medicine for Girls 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 4 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 18 Sep 2026. 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?
Pain severity (time frame: Before the treatment (Baseline), after the first session (T1), second session (T2) will be done after a week from the first session, after 3 months (T3), 6 months (T6), 9 months (T9) and 12 months (T12)). 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 18 Sep 2026.