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

Comparative Efficacy of Erbium and Diode Laser Systems Alone or Combined With Fluoride-Based Desensitizing Agent in the Management of Dentinal Hypersensitivity: A Randomized Controlled Clinical Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Dentin Sensitivity, Dentine Hypersensitivity, Tooth Sensitivity
• Intervention / Treatment: Other: Diode laser (650 nm): Visible red light energy; Drug: Fluoride varnish; Other: Erbium laser (2940 nm): Infrared light energy

Detailed Description

This randomized controlled clinical trial investigates the comparative efficacy of different laser systems and fluoride-based treatments for managing dentinal hypersensitivity, a prevalent clinical condition characterized by sharp, transient pain from exposed dentin in response to thermal, evaporative, tactile, or chemical stimuli. The study will recruit 96 participants aged 18-45 years with dentinal hypersensitivity scores ≥4 on a Visual Analogue Scale (VAS), randomly allocating them into four equal groups (n=24 each): Group 1 receiving Erbium:YAG laser treatment (2940 nm, 80mJ, 2Hz) which works through thermal tubule occlusion; Group 2 receiving Diode laser photobiomodulation therapy (650 nm, 100mW, 2J total dose) targeting neural modulation; Group 3 receiving combination therapy of Diode laser with 5% sodium fluoride varnish to exploit synergistic mechanisms; and Group 4 receiving fluoride varnish alone as the control comparator. The primary outcome measures dentinal hypersensitivity reduction using VAS scores (0-10 scale) assessed through standardized evaporative stimulus tests at baseline, 1 week, 4 weeks, and 6 months post-treatment, while secondary outcomes include patient satisfaction and treatment tolerability. Conducted at the Conservative Dentistry Department, Faculty of Dentistry, Cairo University, with blinded outcome assessors and standardized protocols, this superiority trial addresses the clinical need for evidence-based, long-term effective treatments for dentinal hypersensitivity by comparing individual laser modalities against combination therapy and established fluoride treatments, potentially establishing optimal therapeutic protocols that provide both immediate relief and sustained tubule occlusion or neural modulation for improved patient quality of life.

• Study Type: Interventional
• Enrollment (Estimated): 96
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

• 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

Exclusion Criteria

• 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

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
Experimental: Erbium Laser; 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; Non-ionizing radiation or more accurately as optical energy devices, not ionizing radiation.; Drug: Fluoride varnish; Biological Intervention
Experimental: Diode Laser; Diode laser (650 nm) photobiomodulation therapy alone targeting neural modulation to reduce pain transmission.	Drug: Fluoride varnish; Biological Intervention; Other: Erbium laser (2940 nm): Infrared light energy; 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.
Experimental: Combination Therapy; Diode laser (650 nm) followed immediately by fluoride varnish application combining neural modulation with tubule occlusion.	Other: Diode laser (650 nm): Visible red light energy; Non-ionizing radiation or more accurately as optical energy devices, not ionizing radiation.; Drug: Fluoride varnish; Biological Intervention; Other: Erbium laser (2940 nm): Infrared light energy; 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.
Active Comparator: Fluoride Control; 5% sodium fluoride varnish alone serving as active control, promoting remineralization and tubule occlusion through standard treatment.	Other: Diode laser (650 nm): Visible red light energy; Non-ionizing radiation or more accurately as optical energy devices, not ionizing radiation.; Other: Erbium laser (2940 nm): Infrared light energy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dentinal Hypersensitivity Assessment	Dentinal Hypersensitivity Assessment Using Visual Analogue Scale	at baseline, 1 week, 4 weeks, and 6 months post-treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Satisfaction	The secondary outcome measures patient satisfaction with treatment using a categorical Yes/No assessment. Participants report their overall satisfaction with the assigned intervention based on perceived pain relief.	at baseline, 1 week, 4 weeks, and 6 months post-treatment

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: August 19, 2025
• First Submitted That Met QC Criteria: August 19, 2025
• First Posted (Estimated): August 26, 2025

Study Record Updates

• Last Update Posted (Estimated): August 26, 2025
• Last Update Submitted That Met QC Criteria: August 19, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Sensitivity, Laser, Hypersensitivity
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Immune System Diseases; Tooth Diseases; Hypersensitivity; Dentin Sensitivity; Equipment and Supplies; Lasers; Optical Devices; Radiation Equipment and Supplies; Lasers, Semiconductor
• Other Study ID Numbers: CairoU-Laser Hypersensitivity

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No