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NCT Number: NCT07449169

Diode Laser Plus CPP-ACPF vs CPP-ACPF Alone for Dentin Hypersensitivity

This study aims to compare the effectiveness of diode laser photobiomodulation combined with CPP-ACPF varnish versus CPP-ACPF varnish alone in reducing dentin hypersensitivity. Participants diagnosed with dentin hypersensitivity will receive either the combined treatment or varnish application alone. Pain levels will be evaluated using a standardized visual analog scale before and after treatment sessions. The results of this study may help determine whether adding diode laser therapy enhances the effectiveness of conventional varnish treatment in managing dentin hypersensitivity.

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Key information

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

This study is a clinical trial designed to evaluate the effectiveness of two treatments for dentin hypersensitivity, which is the pain or discomfort felt when teeth are exposed to hot, cold, sweet, or touch.

Participants who meet the study criteria will be randomly assigned to one of two groups:

Group A: Treatment with a diode laser combined with CPP-ACPF varnish applied to the sensitive teeth.

Group B: Treatment with CPP-ACPF varnish alone.

Study Procedures:

Screening and Enrollment: Participants will undergo a dental examination to confirm they have sensitive teeth. Medical history and consent will be collected.

Baseline Assessment: Pain sensitivity will be measured using a simple pain scale to record how severe the sensitivity is before treatment.

Treatment: The assigned treatment will be applied to the sensitive teeth. The laser procedure is painless and safe, and the varnish is a commonly used dental material.

Follow-Up Visits: Participants will return for follow-up assessments immediately after treatment, after one month, after three months, and after six months. Pain sensitivity will be measured at each visit to track changes over time.

Safety and Monitoring:

The procedures are safe, and side effects are expected to be minimal.

Any discomfort or unexpected reactions will be addressed promptly by the dental team.

Participants can withdraw from the study at any time without affecting their standard dental care.

Purpose of the Study:

The goal is to determine whether combining diode laser treatment with CPP-ACPF varnish is more effective at reducing tooth sensitivity than using the varnish alone. The results may help dentists provide the best treatment options for patients with sensitive teeth in the future.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult participants aged from 20 to 50 years of age.
  • Participants with good oral hygiene.
  • Presence of at least one tooth with dentin hypersensitivity confirmed by the air blast and/or tactile stimuli (scoring ≥3 on the VAS).
  • Participants willing to cooperate and attend recall appointments
  • Teeth with Non-Carious Cervical Lesions.
  • Patients with dentin hypersensitivity due to GERD and Parafunctional habits e.g., bruxism.
  • Patients with dentin hypersensitivity associated with gingival recession.

Exclusion criteria

  • Participants with poor oral hygiene.
  • History of professional or at-home desensitizing treatment within the previous 3 months.
  • Pregnant or lactating females.
  • Concurrent participation in other research studies.
  • Inability to comply with study procedures.
  • History of allergic reactions to study materials.
  • Medical conditions interfering with pain reporting accuracy (pain disorders, constant use of analgesics, anti-inflammatory, or psychotropic medications).
  • History of periodontal surgeries within the last six months.
  • Periodontitis and pulpitis.

Treatment and study plan

Diode laser photobiomodulation combined with CPP-ACPF varnish

Device

Participants will receive diode laser photobiomodulation applied to sensitive teeth followed by application of CPP-ACPF varnish according to the manufacturer's instructions. This combination treatment is intended to reduce dentin hypersensitivity.

Other names: Diode laser therapy, Low-level laser therapy (LLLT), photobiomodulation, PBM

CPP-ACPF varnish

Other

Participants will receive CPP-ACPF varnish applied to sensitive teeth according to the manufacturer's instructions to reduce dentin hypersensitivity.

Other names: Casein phosphopeptide-amorphous calcium phosphate fluoride varnish

Primary outcomes

  1. Reduction in dentin hypersensitivity in response to evaporative (air-blast) stimulus

    Time frame: Assessed at baseline, immediately post-treatment, and at 1 month, 3 months, and 6 months follow-up.

    Change in dentin hypersensitivity in response to an evaporative (air-blast) stimulus, measured using a visual analog scale (VAS). Lower scores indicate reduced sensitivity.

    Scores: 0-10 (Ordinal) where 0 represents "no pain" and 10 represents "greatest pain".

Secondary outcomes

  1. Reduction in dentin hypersensitivity in response to tactile (dental probe) stimulus.

    Time frame: Assessed at baseline, immediately post-treatment, and at 1 month, 3 months, and 6 months follow-up.

    Change in dentin hypersensitivity in response to a tactile stimulus using a dental probe, measured with a visual analog scale (VAS). Lower scores indicate reduced sensitivity.

    Scores: 0-10 (Ordinal) where 0 represents "no pain" and 10 represents "greatest pain".

Study contacts

Contact information is provided by the study sponsor or research team.

Mariam M Mohamed, Master's candidate

CONTACT

[email protected]

+20 100 088 2942

Mona M Eissa

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Comparative Efficacy of Diode Laser Photobiomodulation Combined With CPP-ACPF Varnish Versus CPP-ACPF Varnish Alone in the Management of Dentin Hypersensitivity: A Randomized Clinical Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 4, 2026
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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