Comparative Efficacy of Laser Systems and Fluoride in Managing Dentinal Hypersensitivity: RCT

NCT07141576 | Not Yet Recruiting DMC

• 1 other identifier: CairoU-Laser Hypersensitivity
• Study Type: interventional
• Target: 96
• Locations: 0 countries
• Sites: N/A

Brief Summary

This randomized controlled clinical trial aims to compare the effectiveness of Erbium laser (2940 nm), Diode laser (650 nm), combination Diode laser with fluoride varnish, and fluoride varnish alone in treating dentinal hypersensitivity. The study will recruit 96 adults aged 18-45 years with tooth sensitivity scores ≥4 on a 0-10 Visual Analogue Scale, randomly allocating 24 participants to each of four treatment groups. The primary outcome is reduction in tooth sensitivity measured at baseline, 1 week, 4 weeks, and 6 months post-treatment, with patient satisfaction as a secondary outcome. Conducted at Cairo University's Faculty of Dentistry, this 6-month follow-up study addresses the limitation of current treatments that provide only temporary relief, seeking to establish evidence-based protocols for optimal long-term management of dentinal hypersensitivity by evaluating whether laser therapies alone or in combination with fluoride offer superior and more durable pain relief compared to standard fluoride treatment alone.

Conditions

Dentin Sensitivity, Dentine Hypersensitivity, Tooth Sensitivity

Keywords

Sensitivity, Laser, Hypersensitivity

Outcome Measures

Primary Outcomes (1)

• Dentinal Hypersensitivity Assessment

  Dentinal Hypersensitivity Assessment Using Visual Analogue Scale

  at baseline, 1 week, 4 weeks, and 6 months post-treatment

Secondary Outcomes (1)

• Patient Satisfaction

  at baseline, 1 week, 4 weeks, and 6 months post-treatment

Study Arms (4)

Erbium Laser

EXPERIMENTAL

Erbium:YAG laser (2940 nm) treatment alone using thermal ablation to seal dentinal tubules and reduce hypersensitivity.

Other: Diode laser (650 nm): Visible red light energy; Drug: Fluoride varnish

Diode Laser

EXPERIMENTAL

Diode laser (650 nm) photobiomodulation therapy alone targeting neural modulation to reduce pain transmission.

Other: Erbium laser (2940 nm): Infrared light energy; Drug: Fluoride varnish

Combination Therapy

EXPERIMENTAL

Diode laser (650 nm) followed immediately by fluoride varnish application combining neural modulation with tubule occlusion.

Other: Erbium laser (2940 nm): Infrared light energy; Other: Diode laser (650 nm): Visible red light energy; Drug: Fluoride varnish

Fluoride Control

ACTIVE COMPARATOR

5% sodium fluoride varnish alone serving as active control, promoting remineralization and tubule occlusion through standard treatment.

Other: Erbium laser (2940 nm): Infrared light energy; Other: Diode laser (650 nm): Visible red light energy

Interventions

Erbium laser (2940 nm): Infrared light energy OTHER

The lasers emit light energy in the infrared and visible spectrum, which is fundamentally different from ionizing radiation (like X-rays or gamma rays) that can damage DNA. Dental lasers work through photobiomodulation and thermal effects, not through radiation exposure.

Combination Therapy; Diode Laser; Fluoride Control

Diode laser (650 nm): Visible red light energy OTHER

Non-ionizing radiation or more accurately as optical energy devices, not ionizing radiation.

Combination Therapy; Erbium Laser; Fluoride Control

Fluoride varnish DRUG

Biological Intervention

Combination Therapy; Diode Laser; Erbium Laser

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adults aged 18-45 years
• Both sexes eligible
• Good general health status
• At least one tooth with cervical dentin hypersensitivity (CDH)
• Visual Analogue Scale (VAS) pain score ≥ 4 on evaporative stimulus test using dental syringe air jet
• Willing to participate and provide informed consent

You may not qualify if:

• Active carious lesions or defective restorations requiring treatment
• Loss of dental tissue requiring restorative treatment
• Previous professional desensitizing treatment within 6 months prior to recruitment
• Use of desensitizing toothpastes within 3 months prior to study
• Current use of anti-inflammatory drugs or analgesics at time of recruitment
• Pregnant or breastfeeding women
• Inability to comply with study protocol or follow-up requirements

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Dentin Sensitivity; Hypersensitivity

Interventions

Lasers, Semiconductor

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This randomized controlled trial uses a single-blind, parallel-group design to compare four treatments for dentinal hypersensitivity in 96 participants. Using computer-generated randomization and sealed envelope allocation, participants are equally divided into four groups receiving Erbium laser, Diode laser, combination Diode laser with fluoride, or fluoride alone. The study employs single-blind masking where outcome assessors and statisticians remain blinded to treatment assignments, while sham procedures (simulated laser/fluoride applications) minimize bias where complete blinding is impossible. Participants are followed for 6 months with Visual Analogue Scale measurements at baseline, 1 week, 4 weeks, and 6 months to assess treatment effectiveness using standardized protocols and pre-calibrated examiners.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Model Details: This randomized controlled trial uses a single-blind, parallel-group design to compare four treatments for dentinal hypersensitivity in 96 participants. Using computer-generated randomization and sealed envelope allocation, participants are equally divided into four groups receiving Erbium laser, Diode laser, combination Diode laser with fluoride, or fluoride alone. The study employs blinded outcome assessors, sham procedures to minimize bias, and follows participants for 6 months with Visual Analogue Scale measurements at baseline, 1 week, 4 weeks, and 6 months to assess treatment effectiveness.

Study Record Dates

• First Submitted: August 19, 2025
• First Posted: August 26, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share