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

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

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.

Study Overview

• Status: Completed
• Conditions: Dentin Hypersensitivity
• Intervention / Treatment: Combination product: Sodium fluoride varnish; Other: Curodont De Senz; Combination product: Curodont De Senz plus laser irradiation; Device: Laser irradiation

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.

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • MTI University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Sodium fluoride varnish	Combination product: Sodium fluoride varnish; Sodium fluoride varnish
Experimental: Curodont De senz; Curodont De Senz	Other: Curodont De Senz; Curodont De Senz
Experimental: Curodont De Senz plus laser irradiation	Combination product: Curodont De Senz plus laser irradiation; Curodont De Senz plus laser irradiation
Experimental: Laser irradiation	Device: Laser irradiation; Laser irradiation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dentin hypersensitivity	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.	Baseline - 15 minutes- 2 weeks - 1 month - 3 months
A- Tactile test	By explorer	Baseline - 15 minutes- 2 weeks - 1 month - 3 months
B- Evaporative test	By air syringe	Baseline - 15 minutes - 2 weeks- 1 month - 3 months
C- Thermal Test	By refreigent spray	Baseline - 15 minutes - 2 weeks- 1 month - 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Salivary Ph assessment	All participants will be instructed not to eat or drink at least one hour before collecting saliva. Before collecting saliva, patients will be asked to rinse with water and then wait for two minutes for water clearance. Unstimulated saliva will be collected by making the subjects sit upright with the head slightly inclined. The passively drooled saliva will be collected on the floor of the mouth and then will be expectorated into graduated saliva collecting vials. pH will be measured using a pH meter (Adwa Instruments, Inc., Szeged, Hungary) reading from 0 to 14 (acidic pH < 7 and alkaline pH > 7 and neutral = 7).	Baseline - 15 minutes- 2 weeks - 1 month - 3 months

Collaborators and Investigators

• Sponsor: MTI University
• Investigators: Study Chair: Aalaa M nabil, Lecturer, MTI University; Study Director: Ahmed M Sayed, Assis. prof., MTI University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2024
• Primary Completion (Actual): January 30, 2025
• Study Completion (Actual): January 30, 2025

Study Registration Dates

• First Submitted: February 11, 2025
• First Submitted That Met QC Criteria: February 14, 2025
• First Posted (Actual): February 17, 2025

Study Record Updates

• Last Update Posted (Actual): July 29, 2025
• Last Update Submitted That Met QC Criteria: July 25, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Fluoride varnish; Laser; Curodont de senz
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Immune System Diseases; Tooth Diseases; Hypersensitivity; Dentin Sensitivity; Anti-Infective Agents; Physiological Effects of Drugs; Protective Agents; Anti-Infective Agents, Local; Cariostatic Agents; Fluorides; Listerine; Sodium Fluoride; Fluorides, Topical
• Other Study ID Numbers: Mti-2025-11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: I will not publish in ICMJE

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