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Evaluation of Biomimetic Mineralization Plus Soft Laser Irradiation in Dentin Hypersensitivity Management

Efficacy of Biomimetic Mineralization Approach Plus Soft Laser Irradiation in Management of Dentin Hypersensitivity: A Randomized Clinical Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06829277
Acronym
Rct
Enrollment
84
Registered
2025-02-17
Start date
2024-11-01
Completion date
2025-01-30
Last updated
2025-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dentin Hypersensitivity

Keywords

Curodont de senz, Laser, Fluoride varnish

Brief 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. 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.

Interventions

COMBINATION_PRODUCTSodium fluoride varnish

Sodium fluoride varnish

OTHERCurodont De Senz

Curodont De Senz

COMBINATION_PRODUCTCurodont De Senz plus laser irradiation

Curodont De Senz plus laser irradiation

Laser irradiation

Sponsors

MTI University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Dentin hypersensitivityBaseline - 15 minutes- 2 weeks - 1 month - 3 monthsVisual 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 testBaseline - 15 minutes- 2 weeks - 1 month - 3 monthsBy explorer
B- Evaporative testBaseline - 15 minutes - 2 weeks- 1 month - 3 monthsBy air syringe
C- Thermal TestBaseline - 15 minutes - 2 weeks- 1 month - 3 monthsBy refreigent spray

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026