NCT06829277

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2025

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

February 11, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 17, 2025

Completed
Last Updated

July 29, 2025

Status Verified

July 1, 2025

Enrollment Period

3 months

First QC Date

February 11, 2025

Last Update Submit

July 25, 2025

Conditions

Dentin Hypersensitivity

Keywords

Curodont de senzLaserFluoride varnish

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (4)

Sodium fluoride varnish

ACTIVE COMPARATOR

Sodium fluoride varnish

Combination Product: Sodium fluoride varnish

Curodont De senz

EXPERIMENTAL

Curodont De Senz

Other: Curodont De Senz

Curodont De Senz plus laser irradiation

EXPERIMENTAL

Curodont De Senz plus laser irradiation

Combination Product: Curodont De Senz plus laser irradiation

Laser irradiation

EXPERIMENTAL

Laser irradiation

Device: Laser irradiation

Interventions

Sodium fluoride varnishCOMBINATION_PRODUCT

Sodium fluoride varnish

Sodium fluoride varnish
Curodont De SenzOTHER

Curodont De Senz

Curodont De senz
Curodont De Senz plus laser irradiationCOMBINATION_PRODUCT

Curodont De Senz plus laser irradiation

Curodont De Senz plus laser irradiation
Laser irradiationDEVICE

Laser irradiation

Laser irradiation

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mti university

Cairo, Cairo Governorate, Egypt

Location

MeSH Terms

Conditions

Dentin Sensitivity

Interventions

Bifluorid 12Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapy

Study Officials

  • Aalaa M nabil, Lecturer

    MTI University

    STUDY CHAIR

  • Ahmed M Sayed, Assis. prof.

    MTI University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer in operative dentistry

Study Record Dates

First Submitted

February 11, 2025

First Posted

February 17, 2025

Study Start

November 1, 2024

Primary Completion

January 30, 2025

Study Completion

January 30, 2025

Last Updated

July 29, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

I will not publish in ICMJE

Locations

EG(1)