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

NCT ID: NCT06829277

Last Updated: 2025-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-01

Study Completion Date

2025-01-30

Brief Summary

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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

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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.

Conditions

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Dentin Hypersensitivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Sodium fluoride varnish

Sodium fluoride varnish

Group Type ACTIVE_COMPARATOR

Sodium fluoride varnish

Intervention Type COMBINATION_PRODUCT

Sodium fluoride varnish

Curodont De senz

Curodont De Senz

Group Type EXPERIMENTAL

Curodont De Senz

Intervention Type OTHER

Curodont De Senz

Curodont De Senz plus laser irradiation

Curodont De Senz plus laser irradiation

Group Type EXPERIMENTAL

Curodont De Senz plus laser irradiation

Intervention Type COMBINATION_PRODUCT

Curodont De Senz plus laser irradiation

Laser irradiation

Laser irradiation

Group Type EXPERIMENTAL

Laser irradiation

Intervention Type DEVICE

Laser irradiation

Interventions

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Sodium fluoride varnish

Sodium fluoride varnish

Intervention Type COMBINATION_PRODUCT

Curodont De Senz

Curodont De Senz

Intervention Type OTHER

Curodont De Senz plus laser irradiation

Curodont De Senz plus laser irradiation

Intervention Type COMBINATION_PRODUCT

Laser irradiation

Laser irradiation

Intervention Type DEVICE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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MTI University

OTHER

Sponsor Role lead

Responsible Party

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Mennatallah Atef Aboulnaga

Lecturer in operative dentistry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aalaa M nabil, Lecturer

Role: STUDY_CHAIR

MTI University

Ahmed M Sayed, Assis. prof.

Role: STUDY_DIRECTOR

MTI University

Locations

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Mti university

Cairo, Cairo Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Mti-2025-11

Identifier Type: -

Identifier Source: org_study_id

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