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

NCT ID: NCT07141576

Last Updated: 2025-08-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2026-09-01

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.

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.

Conditions

Dentin Sensitivity, Dentine Hypersensitivity, Tooth Sensitivity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Erbium Laser

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

Group Type: EXPERIMENTAL

Diode laser (650 nm): Visible red light energy

Intervention Type: OTHER

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

Fluoride varnish

Intervention Type: DRUG

Biological Intervention

Diode Laser

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

Group Type: EXPERIMENTAL

Erbium laser (2940 nm): Infrared light energy

Intervention Type: 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.

Fluoride varnish

Intervention Type: DRUG

Biological Intervention

Combination Therapy

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

Group Type: EXPERIMENTAL

Erbium laser (2940 nm): Infrared light energy

Intervention Type: 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.

Diode laser (650 nm): Visible red light energy

Intervention Type: OTHER

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

Fluoride varnish

Intervention Type: DRUG

Biological Intervention

Fluoride Control

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

Group Type: ACTIVE_COMPARATOR

Erbium laser (2940 nm): Infrared light energy

Intervention Type: 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.

Diode laser (650 nm): Visible red light energy

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

Diode laser (650 nm): Visible red light energy

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

Intervention Type: OTHER

Fluoride varnish

Biological Intervention

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ayman Mohamed Elamin Taha

Assistant Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

CairoU-Laser Hypersensitivity

Identifier Type: -

Identifier Source: org_study_id