ClinicalTrials.gg
Not yet recruitingNCT07141576DHLTUpdated Aug 26, 2025

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

An interventional study of Erbium laser (2940 nm): Infrared light energy and Diode laser (650 nm): Visible red light energy in Dentin Sensitivity, Dentine Hypersensitivity, Tooth Sensitivity, sponsored by Cairo University. Not yet recruiting. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2025-08-26.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jul 2026, 4 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
96
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Dentin Sensitivity, Dentine Hypersensitivity, Tooth Sensitivity

Keywords

  • Sensitivity, Laser, Hypersensitivity
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In context

Dentin Sensitivity

288 studies on the registry are indexed under Dentin Sensitivity; 46 are open to participants now.

This study's planned enrollment of 96 is above the median of 60 across 279 interventional studies indexed under Dentin Sensitivity.

Browse Dentin Sensitivity studies →

Lead sponsor

Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
96 participants (estimated)

Study arms

  • 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 · Drug: Fluoride varnish

  • Experimental
    Diode Laser

    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

  • Experimental
    Combination Therapy

    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

  • Active comparator
    Fluoride Control

    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

  • OtherErbium 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.

  • OtherDiode laser (650 nm): Visible red light energy

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

  • Biological Intervention

06

What researchers measure

Primary outcomes

  1. Dentinal Hypersensitivity Assessment

    Dentinal Hypersensitivity Assessment Using Visual Analogue Scale

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

Secondary outcomes

  1. 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.

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

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 26, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07141576
Lead sponsor
Cairo University
Responsible party
Ayman Mohamed Elamin Taha (Assistant Lecturer, Cairo University) — Principal investigator
First posted
Aug 26, 2025
Start date
Sep 1, 2025 (estimated)
Primary completion
Jul 1, 2026 (estimated)
Completion
Sep 1, 2026 (estimated)
Last update
Aug 26, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Sodium Fluoride

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