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Not yet recruitingNCT07449169Updated Mar 4, 2026

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

An interventional study of Diode laser photobiomodulation combined with CPP-ACPF varnish and CPP-ACPF varnish in Dentin Hypersensitivity and Tooth Hypersensitivity, sponsored by Cairo University. Not yet recruiting. Open to participants aged 20 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-03-04.

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

Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
20 Years to 50 Years
Sex
All
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • Dentin Hypersensitivity
  • Tooth Hypersensitivity

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Keywords

  • dentin hypersensitivity
  • tooth hypersensitivity
  • diode laser
  • CPP-ACPF varnish
  • Dental laser treatment
  • Non-carious cervical lesions
  • Desensitizing treatment
  • photobiomodulation
03

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 70 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
20 Years to 50 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

  • Adult participants aged from 20 to 50 years of age.
  • Participants with good oral hygiene.
  • Presence of at least one tooth with dentin 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

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.
Terms in these criteria, in plain language(1)

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.

05

Study design

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

Study arms

  • Experimental
    Group A - Diode Laser + CPP-ACPF

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

    Device: Diode laser photobiomodulation combined with CPP-ACPF varnish

  • Active comparator
    Group B - CPP-ACPF Varnish Alone

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

    Other: CPP-ACPF varnish

Interventions

  • DeviceDiode laser photobiomodulation combined with CPP-ACPF varnish

    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

  • OtherCPP-ACPF varnish

    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

06

What researchers measure

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".

    Time frame: 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.

    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".

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

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Apr 2026; primary completion for Jun 2027, 14 months later.

Of 111 non-industry interventional studies with no phase under Dentin Sensitivity, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 12. This study's planned 14 months is above that.

Counting every sponsor, half of 144 studies reached it within 6 months; a quarter within 3 and three quarters within 10.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 27, 2026
First posted
Mar 4, 2026
StartEst.
Apr 1, 2026
Primary completionEst.
Jun 1, 2027
CompletionEst.
Oct 1, 2027
Last update
Mar 4, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07449169
Lead sponsor
Cairo University
Responsible party
Mariam Mamdouh Mohamed Kamal (Dentist, Cairo University) — Principal investigator
First posted
Mar 4, 2026
Start date
Apr 1, 2026 (estimated)
Primary completion
Jun 1, 2027 (estimated)
Completion
Oct 1, 2027 (estimated)
Last update
Mar 4, 2026

Study contacts

Mariam M Mohamed, Master's candidate
Contact
mariam.kamal@dentistry.cu.edu.eg
+20 100 088 2942

Oversight

Data monitoring committee
No
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 Jan 2026. You cannot join it, but the record below documents what was studied.

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