NCT07449169

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
14mo left

Started Apr 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress22%
Apr 2026Oct 2027

First Submitted

Initial submission to the registry

February 27, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 4, 2026

Completed
28 days until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

March 4, 2026

Status Verified

January 1, 2026

Enrollment Period

1.2 years

First QC Date

February 27, 2026

Last Update Submit

February 27, 2026

Conditions

Dentin HypersensitivityTooth Hypersensitivity

Keywords

dentin hypersensitivitytooth hypersensitivitydiode laserCPP-ACPF varnishDental laser treatmentNon-carious cervical lesionsDesensitizing treatmentphotobiomodulation

Outcome Measures

Primary Outcomes (1)

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

    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".

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

Secondary Outcomes (1)

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

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

Study Arms (2)

Group A - Diode Laser + CPP-ACPF

EXPERIMENTAL

Participants will receive diode laser treatment combined with CPP-ACPF varnish on sensitive teeth.

Device: Diode laser photobiomodulation combined with CPP-ACPF varnish

Group B - CPP-ACPF Varnish Alone

ACTIVE COMPARATOR

Participants will receive CPP-ACPF varnish alone on sensitive teeth.

Other: CPP-ACPF varnish

Interventions

Diode laser photobiomodulation combined with CPP-ACPF varnishDEVICE

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.

Also known as: Diode laser therapy, Low-level laser therapy (LLLT), photobiomodulation, PBM
Group A - Diode Laser + CPP-ACPF
CPP-ACPF varnishOTHER

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

Also known as: Casein phosphopeptide-amorphous calcium phosphate fluoride varnish
Group B - CPP-ACPF Varnish Alone

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dentin Sensitivity

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapy

Central Study Contacts

Mariam M Mohamed, Master's candidate

CONTACT

+20 100 088 2942mariam.kamal@dentistry.cu.edu.eg

Mona M Eissa

CONTACT

monamahmoud@dentistry.cu.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessor and analyst will be blinded to the intervention group assigned to the patients.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dentist

Study Record Dates

First Submitted

February 27, 2026

First Posted

March 4, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

October 1, 2027

Last Updated

March 4, 2026

Record last verified: 2026-01