Skip to main content
OpenTrials
Completed

NCT Number: NCT06829277

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Dentin Hypersensitivity Dentin Sensitivity Stomatognathic Diseases Tooth Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mti university

Cairo, Cairo Governorate, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sodium fluoride varnish

Combination Product

Sodium fluoride varnish

Curodont De Senz

Other

Curodont De Senz

Curodont De Senz plus laser irradiation

Combination Product

Curodont De Senz plus laser irradiation

Laser Irradiation

Device

Laser irradiation

Primary outcomes

  1. 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.

  2. A- Tactile test

    Time frame: Baseline - 15 minutes- 2 weeks - 1 month - 3 months

    By explorer

  3. B- Evaporative test

    Time frame: Baseline - 15 minutes - 2 weeks- 1 month - 3 months

    By air syringe

  4. C- Thermal Test

    Time frame: Baseline - 15 minutes - 2 weeks- 1 month - 3 months

    By refreigent spray

Sponsors and collaborators

Lead sponsor

MTI University

Other

Registry information

Official study title

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

Acronym: Rct

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 17, 2025
Registry last updated
Jul 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.