Dentin HypersensitivityNCT07449169
Diode Laser Plus CPP-ACPF vs CPP-ACPF Alone for Dentin Hypersensitivity
A study testing Diode laser photobiomodulation combined with CPP-ACPF varnish and CPP-ACPF varnish in people with Dentin Hypersensitivity and Tooth Hypersensitivity, run by Cairo University.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Dentin Hypersensitivity, Tooth Hypersensitivity
- What is being tested?
- Diode laser photobiomodulation combined with CPP-ACPF varnish and CPP-ACPF varnish
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 1 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Mona M Eissa contact
About this study
Official 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
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.
- Conditions
- Dentin Hypersensitivity, Tooth Hypersensitivity
- Being tested
- Diode laser photobiomodulation combined with CPP-ACPF varnish, CPP-ACPF varnish
- Keywords
- dentin hypersensitivity, tooth hypersensitivity, diode laser, CPP-ACPF varnish, Dental laser treatment, Non-carious cervical lesions, Desensitizing treatment, photobiomodulation
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diode laser photobiomodulation combined with CPP-ACPF varnishDevice
Also called Diode laser therapy, Low-level laser therapy (LLLT), photobiomodulation, PBM
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.
CPP-ACPF varnishOther
Also called Casein phosphopeptide-amorphous calcium phosphate fluoride varnish
Participants will receive CPP-ACPF varnish applied to sensitive teeth according to the manufacturer's instructions to reduce dentin hypersensitivity.
| Study group | Role | What they receive |
|---|---|---|
| Group A - Diode Laser + CPP-ACPF | Experimental | Participants will receive diode laser treatment combined with CPP-ACPF varnish on sensitive teeth. Receives: 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. Receives: Other: CPP-ACPF varnish |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 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".
Measured: Assessed at baseline, immediately post-treatment, and at 1 month, 3 months, and 6 months follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dentin HypersensitivityStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam Mamdouh Mohamed Kamal, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07449169
- Sponsor's protocol ID
- Cons-DH-2026
- Status last verified
- Jan 2026
- First submitted
- 27 Feb 2026
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07449169
- Acronym / sponsor ID
- Cons-DH-2026
- Conditions
- Dentin Hypersensitivity, Tooth Hypersensitivity
- Keywords
- dentin hypersensitivity, tooth hypersensitivity, diode laser, CPP-ACPF varnish, Dental laser treatment, Non-carious cervical lesions, Desensitizing treatment, photobiomodulation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 4 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A - Diode Laser + CPP-ACPF | Experimental | Device: Diode laser photobiomodulation combined with CPP-ACPF varnishParticipants will receive diode laser treatment combined with CPP-ACPF varnish on sensitive teeth. |
| Group B - CPP-ACPF Varnish Alone | Active comparator | Other: CPP-ACPF varnishParticipants will receive CPP-ACPF varnish alone on sensitive teeth. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diode laser photobiomodulation combined with CPP-ACPF varnishAlso: Diode laser therapy, Low-level laser therapy (LLLT), photobiomodulation, PBMParticipants 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. | Device | Group A - Diode Laser + CPP-ACPF |
| CPP-ACPF varnishAlso: Casein phosphopeptide-amorphous calcium phosphate fluoride varnishParticipants will receive CPP-ACPF varnish applied to sensitive teeth according to the manufacturer's instructions to reduce dentin hypersensitivity. | Other | Group B - CPP-ACPF Varnish Alone |
Primary outcome
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".
1 secondary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mona M Eissa contact
Questions about this trial
What is this clinical trial studying?
A study testing Diode laser photobiomodulation combined with CPP-ACPF varnish and CPP-ACPF varnish in people with Dentin Hypersensitivity and Tooth Hypersensitivity, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mariam M Mohamed, Master's candidate (+20 100 088 2942, mariam.kamal@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026; AzTrials last refreshed its copy on 27 Oct 2026.