Effectiveness of Resin-Based Desensitizer and Laser, Compared to Fluoride Varnish in Management of Dentine Hypersensitivity in Non-carious Cervical Lesions

NCT07113847 | Active Not Recruiting Phase 2

• 1 other identifier: 24-011
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

84 patients who fulfill the inclusion criteria will be enrolled to the study. For every patient a tooth of complain which fulfill the inclusion criteria will be selected, so the total number of included teeth will be 84 teeth. Teeth will be classified into 4 groups according to the type of desensitizer used. Where in group 1 (G1) patients will be randomly assigned to "Resin-Based Desensitizer", in group 2 (G2) patients will be randomly assigned to "Laser Desensitizer", in group 3 (G3) patients will be randomly assigned to "Combination of Laser + Resin-Based Desensitizer", and in group 4 (G4) patients will be randomly assigned to "Fluoride-Based Desensitizer". For every patient, sensitivity test will be done using visual analogue scale immediately after application, three months after application and six months after application. Table 1 shows the variables of the study, and Table 2 shows the variables of the study. Each patient's name will be replaced with a case number within the group to protect the privacy of medical information and data of the patients.

Conditions

Dentin Hypersensitivity, Non-carious Cervical Lesions, Bioactive Glass Air Polishing, S-PRG; Dentin Hypersensitivity; Dentin Desensitizing Agents; Desensitization

Outcome Measures

Primary Outcomes (1)

• visual analogue scale (VAS)

  post-operative hypersensitivity assessment with the visual analogue scale from 0-10 with 0 is the minimum sensitivity record and 10 is the maximum sensitivity record

  0,3,6 months

Study Arms (4)

Resin-Based Desensitizer

ACTIVE COMPARATOR

Biological: Resin-Based Desensitizer

Laser Desensitizer

ACTIVE COMPARATOR

Device: Laser Desensitizer

Combination of Laser + Resin-Based Desensitizer

ACTIVE COMPARATOR

Biological: Resin-Based Desensitizer; Device: Laser Desensitizer

Fluoride-Based Desensitizer

ACTIVE COMPARATOR

Biological: Fluoride-Based Desensitizer

Interventions

Resin-Based Desensitizer BIOLOGICAL

resin desensitizing agent

Combination of Laser + Resin-Based Desensitizer; Resin-Based Desensitizer

Laser Desensitizer DEVICE

Low-power Diode laser

Combination of Laser + Resin-Based Desensitizer; Laser Desensitizer

Fluoride-Based Desensitizer BIOLOGICAL

Fluoride-based varnish

Fluoride-Based Desensitizer

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Males or Females
• years.
• Not received antibiotic therapy for 1 month before sampling.
• Good oral hygiene.
• Co-operative patients approving the trial.
• Compliant patients.

You may not qualify if:

• Pregnancy.
• Systemic disease or severe medical complications.
• Patients who did any periodontal surgeries within the previous 6 months.
• Patients with bad oral hygiene.
• Patients who are allergic to any ingredients used in the study.
• Xerostomia.
• Lack of compliance.
• Non carious lesions.
• Cervical lesions.
• Teeth with DH, VAS \>5.
• Carious teeth.
• Chipped teeth.
• Teeth with mobility Grade 2 or 3.
• Teeth with probing depth more than 4 mm.

Sponsors & Collaborators

• British University In Egypt: lead

Study Sites (1)

BUE

Cairo, El Shorouk City, Egypt

Location

MeSH Terms

Conditions

Dentin Sensitivity

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Demonstrator

Model Details: 84 patients who fulfill the inclusion criteria will be enrolled to the study. For every patient a tooth of complain which fulfill the inclusion criteria will be selected, so the total number of included teeth will be 84 teeth. Teeth will be classified into 4 groups according to the type of desensitizer used. Where in group 1 (G1) patients will be randomly assigned to "Resin-Based Desensitizer", in group 2 (G2) patients will be randomly assigned to "Laser Desensitizer", in group 3 (G3) patients will be randomly assigned to "Combination of Laser + Resin-Based Desensitizer", and in group 4 (G4) patients will be randomly assigned to "Fluoride-Based Desensitizer". For every patient, sensitivity test will be done using visual analogue scale immediately after application, three months after application and six months after application. Table 1 shows the variables of the study,

Study Record Dates

• First Submitted: August 3, 2025
• First Posted: August 11, 2025
• Study Start: April 1, 2025
• Primary Completion: October 1, 2025
• Study Completion: October 30, 2025
• Last Updated: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 1 year

Locations

EG (1)