- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07418788
Polymeric Nano Calcium Fluoride Varnish, Diode Laser, and Their Combination for Dentin Hypersensitivity
February 11, 2026 updated by: Bassant Bahaa El Din Ibrahim, Faculty of Dental Medicine for Girls
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
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Cairo, Egypt, 4470351
- Faculty of Dental Medicine for Girls
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
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
Exclusion Criteria:
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group 1 (OliNano Seal)
OliNano Seal (polymeric nano calcium fluoride containing varnish)
|
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)
|
|
Active Comparator: Group 2 (Diode laser)
Diode laser
|
increase in the metabolic activity of odontoblasts.
Thus, obliteration of the dentinal tubules and formation of tertiary dentin.
|
|
Experimental: Group 3 (OliNano Seal and Diode laser)
OliNano Seal and Diode laser
|
Combined methods have been also evaluated in some previous studies.
It showed more effect in reducing Dentin hypersensitivity than using every treatment solely
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
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)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 15, 2025
Primary Completion (Actual)
July 10, 2025
Study Completion (Estimated)
July 16, 2026
Study Registration Dates
First Submitted
January 20, 2026
First Submitted That Met QC Criteria
February 11, 2026
First Posted (Actual)
February 18, 2026
Study Record Updates
Last Update Posted (Actual)
February 18, 2026
Last Update Submitted That Met QC Criteria
February 11, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P-OP-24-08
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Sharing Time Frame
Start date: After publication, End Date: 10 years
IPD Sharing Access Criteria
After publication through the corresponding author
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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