Polymeric Nano Calcium Fluoride Varnish, Diode Laser, and Their Combination for Dentin Hypersensitivity

NCT07418788 | Active Not Recruiting DMC

• 1 other identifier: P-OP-24-08
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Dentin Hypersensitivity, Non-carious Cervical Lesions; Gingival Recession Localized Moderate

Keywords

Dentin Hypersensitivity; Laser; Olinano Seal; Dual Treatment

Outcome Measures

Primary Outcomes (1)

• 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

  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)

Study Arms (3)

Group 1 (OliNano Seal)

EXPERIMENTAL

OliNano Seal (polymeric nano calcium fluoride containing varnish)

Other: Olinano seal

Group 2 (Diode laser)

ACTIVE COMPARATOR

Diode laser

Device: Diode Laser

Group 3 (OliNano Seal and Diode laser)

EXPERIMENTAL

OliNano Seal and Diode laser

Other: Olinano seal and Diode Laser

Interventions

Olinano seal OTHER

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)

Group 1 (OliNano Seal)

Diode Laser DEVICE

increase in the metabolic activity of odontoblasts. Thus, obliteration of the dentinal tubules and formation of tertiary dentin.

Group 2 (Diode laser)

Olinano seal and Diode Laser OTHER

Combined methods have been also evaluated in some previous studies. It showed more effect in reducing Dentin hypersensitivity than using every treatment solely

Group 3 (OliNano Seal and Diode laser)

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Faculty of Dental Medicine for Girls: lead

Study Sites (1)

Faculty of Dental medicine for Girls

Cairo, 4470351, Egypt

Location

MeSH Terms

Conditions

Dentin Sensitivity

Interventions

Lasers, Semiconductor

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Restorative Dentistry

Study Record Dates

• First Submitted: January 20, 2026
• First Posted: February 18, 2026
• Study Start: May 15, 2025
• Primary Completion: July 10, 2025
• Study Completion (Estimated): July 16, 2026
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Start date: After publication, End Date: 10 years
• Access Criteria: After publication through the corresponding author

Locations

EG (1)