Dentin Sensitivity, Dentine Hypersensitivity, Tooth SensitivityDHLTNCT07141576
Comparative Efficacy of Laser Systems and Fluoride in Managing Dentinal Hypersensitivity: RCT
A study testing Erbium laser (2940 nm): Infrared light energy, Diode laser (650 nm): Visible red light energy and Fluoride varnish in people with Dentin Sensitivity, Dentine Hypersensitivity, Tooth Sensitivity, run by Cairo University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Dentin Sensitivity, Dentine Hypersensitivity, Tooth Sensitivity
- What is being tested?
- Erbium laser (2940 nm): Infrared light energy, Diode laser (650 nm): Visible red light energy and Fluoride varnish
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 1 Sep 2026
- 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 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults aged 18-45 years
- Both sexes eligible
- Good general health status
- At least one tooth with cervical dentin hypersensitivity (CDH)
- Visual Analogue Scale (VAS) pain score ≥ 4 on evaporative stimulus test using dental syringe air jet
- Willing to participate and provide informed consent
Who cannot join
- 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
About this study
Official title: Comparative Efficacy of Erbium and Diode Laser Systems Alone or Combined With Fluoride-Based Desensitizing Agent in the Management of Dentinal Hypersensitivity: A Randomized Controlled Clinical Trial
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.
- Being tested
- Erbium laser (2940 nm): Infrared light energy, Diode laser (650 nm): Visible red light energy, Fluoride varnish
- Keywords
- Sensitivity, Laser, Hypersensitivity
- Medical subject headings
- Dentin Sensitivity, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erbium laser (2940 nm): Infrared light energyOther
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.
Diode laser (650 nm): Visible red light energyOther
Non-ionizing radiation or more accurately as optical energy devices, not ionizing radiation.
Fluoride varnishDrug
Biological Intervention
| Study group | Role | What they receive |
|---|---|---|
| Erbium Laser | Experimental | Erbium:YAG laser (2940 nm) treatment alone using thermal ablation to seal dentinal tubules and reduce hypersensitivity. Receives: Other: Diode laser (650 nm): Visible red light energy; Drug: Fluoride varnish |
| Diode Laser | Experimental | Diode laser (650 nm) photobiomodulation therapy alone targeting neural modulation to reduce pain transmission. Receives: Other: Erbium laser (2940 nm): Infrared light energy; Drug: Fluoride varnish |
| Combination Therapy | Experimental | Diode laser (650 nm) followed immediately by fluoride varnish application combining neural modulation with tubule occlusion. Receives: Other: Erbium laser (2940 nm): Infrared light energy; Other: Diode laser (650 nm): Visible red light energy; Drug: Fluoride varnish |
| Fluoride Control | Active comparator | 5% sodium fluoride varnish alone serving as active control, promoting remineralization and tubule occlusion through standard treatment. Receives: Other: Erbium laser (2940 nm): Infrared light energy; Other: Diode laser (650 nm): Visible red light energy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dentinal Hypersensitivity Assessment
Dentinal Hypersensitivity Assessment Using Visual Analogue Scale
Measured: 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.
Measured: at baseline, 1 week, 4 weeks, and 6 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dentin Sensitivity, Dentine Hypersensitivity, Tooth SensitivityStudies 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
- Model description
- This randomized controlled trial uses a single-blind, parallel-group design to compare four treatments for dentinal hypersensitivity in 96 participants. Using computer-generated randomization and sealed envelope allocation, participants are equally divided into four groups receiving Erbium laser, Diode laser, combination Diode laser with fluoride, or fluoride alone. The study employs blinded outcome assessors, sham procedures to minimize bias, and follows participants for 6 months with Visual Analogue Scale measurements at baseline, 1 week, 4 weeks, and 6 months to assess treatment effectiveness.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayman Mohamed Elamin Taha, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07141576
- Sponsor's protocol ID
- CairoU-Laser Hypersensitivity
- Acronym
- DHLT
- Status last verified
- Aug 2025
- First submitted
- 19 Aug 2025
- Last updated
- 26 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Efficacy of Erbium and Diode Laser Systems Alone or Combined With Fluoride-Based Desensitizing Agent in the Management of Dentinal Hypersensitivity: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07141576
- Acronym / sponsor ID
- DHLT / CairoU-Laser Hypersensitivity
- Keywords
- Sensitivity, Laser, Hypersensitivity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 26 Aug 2025 (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 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- This randomized controlled trial uses a single-blind, parallel-group design to compare four treatments for dentinal hypersensitivity in 96 participants. Using computer-generated randomization and sealed envelope allocation, participants are equally divided into four groups receiving Erbium laser, Diode laser, combination Diode laser with fluoride, or fluoride alone. The study employs blinded outcome assessors, sham procedures to minimize bias, and follows participants for 6 months with Visual Analogue Scale measurements at baseline, 1 week, 4 weeks, and 6 months to assess treatment effectiveness.
| Arm | Type | Receives |
|---|---|---|
| Erbium Laser | Experimental | Other: Diode laser (650 nm): Visible red light energy, Drug: Fluoride varnishErbium:YAG laser (2940 nm) treatment alone using thermal ablation to seal dentinal tubules and reduce hypersensitivity. |
| Diode Laser | Experimental | Other: Erbium laser (2940 nm): Infrared light energy, Drug: Fluoride varnishDiode laser (650 nm) photobiomodulation therapy alone targeting neural modulation to reduce pain transmission. |
| Combination Therapy | Experimental | Other: Erbium laser (2940 nm): Infrared light energy, Other: Diode laser (650 nm): Visible red light energy, Drug: Fluoride varnishDiode laser (650 nm) followed immediately by fluoride varnish application combining neural modulation with tubule occlusion. |
| Fluoride Control | Active comparator | Other: Erbium laser (2940 nm): Infrared light energy, Other: Diode laser (650 nm): Visible red light energy5% sodium fluoride varnish alone serving as active control, promoting remineralization and tubule occlusion through standard treatment. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Adults aged 18-45 years
- Both sexes eligible
- Good general health status
- At least one tooth with cervical dentin hypersensitivity (CDH)
- Visual Analogue Scale (VAS) pain score ≥ 4 on evaporative stimulus test using dental syringe air jet
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Erbium laser (2940 nm): Infrared light energyThe 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. | Other | Combination Therapy, Diode Laser, Fluoride Control |
| Diode laser (650 nm): Visible red light energyNon-ionizing radiation or more accurately as optical energy devices, not ionizing radiation. | Other | Combination Therapy, Erbium Laser, Fluoride Control |
| Fluoride varnishBiological Intervention | Drug | Combination Therapy, Diode Laser, Erbium Laser |
Primary outcome
Dentinal Hypersensitivity Assessment
Time frame: at baseline, 1 week, 4 weeks, and 6 months post-treatment
Dentinal Hypersensitivity Assessment Using Visual Analogue Scale
1 secondary outcome
Patient Satisfaction
Time frame: at baseline, 1 week, 4 weeks, and 6 months post-treatment
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 26 Aug 2025.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Erbium laser (2940 nm): Infrared light energy, Diode laser (650 nm): Visible red light energy and Fluoride varnish in people with Dentin Sensitivity, Dentine Hypersensitivity, Tooth Sensitivity, 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 6 inclusion and 7 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 26 Aug 2025. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dentinal Hypersensitivity Assessment (time frame: at baseline, 1 week, 4 weeks, and 6 months post-treatment). 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 26 Aug 2025; AzTrials last refreshed its copy on 6 Nov 2026.