Dentin Hypersensitivity, Non-carious Cervical Lesions, Bioactive Glass Air Polishing, S-PRGPhase 2/3NCT07113847
Effectiveness of Resin-Based Desensitizer and Laser, Compared to Fluoride Varnish in Management of Dentine Hypersensitivity in Non-carious Cervical Lesions
A Phase 2/3 study testing Resin-Based Desensitizer, Laser Desensitizer and Fluoride-Based Desensitizer in people with Dentin Hypersensitivity, Non-carious Cervical Lesions, Bioactive Glass Air Polishing, S-PRG and Dentin Hypersensitivity, run by British University In Egypt at 1 site in Egypt.
Trial summary
84 patients who fulfill the inclusion criteria will be enrolled to the study. For every patient a tooth of complain which fulfill the inclusion criteria will be selected, so the total number of included teeth will be 84 teeth. Teeth will be classified into 4 groups according to the type of desensitizer used. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Dentin Hypersensitivity, Non-carious Cervical Lesions, Bioactive Glass Air Polishing, S-PRG, Dentin Hypersensitivity, Dentin Desensitizing Agents
- What is being tested?
- Resin-Based Desensitizer, Laser Desensitizer and Fluoride-Based Desensitizer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2025to 30 Oct 2025
- Phase
- Phase 2/3
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males or Females
- 18 -50 years.
- Not received antibiotic therapy for 1 month before sampling.
- Good oral hygiene.
- Co-operative patients approving the trial.
- Compliant patients.
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- Non carious lesions.
- Cervical lesions.
- Teeth with DH, VAS >5.
Who cannot join
- Pregnancy.
- Systemic disease or severe medical complications.
- Patients who did any periodontal surgeries within the previous 6 months.
- Patients with bad oral hygiene.
- Patients who are allergic to any ingredients used in the study.
- Xerostomia.
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- Lack of compliance.
- Carious teeth.
- Chipped teeth.
- Teeth with mobility Grade 2 or 3.
- Teeth with probing depth more than 4 mm.
Trial locations and contacts
1 site in 1 country.
About this study
84 patients who fulfill the inclusion criteria will be enrolled to the study. For every patient a tooth of complain which fulfill the inclusion criteria will be selected, so the total number of included teeth will be 84 teeth. Teeth will be classified into 4 groups according to the type of desensitizer used. Where in group 1 (G1) patients will be randomly assigned to "Resin-Based Desensitizer", in group 2 (G2) patients will be randomly assigned to "Laser Desensitizer", in group 3 (G3) patients will be randomly assigned to "Combination of Laser + Resin-Based Desensitizer", and in group 4 (G4) patients will be randomly assigned to "Fluoride-Based Desensitizer". For every patient, sensitivity test will be done using visual analogue scale immediately after application, three months after application and six months after application. Table 1 shows the variables of the study, and Table 2 shows the variables of the study.
Each patient's name will be replaced with a case number within the group to protect the privacy of medical information and data of the patients.
Read the detailed description
- Participants Randomization and Allocation: Using computer generated randomization, the participants will be allocated randomly into four equal groups. The sequentially numbers that will be generated, will be placed in opaque envelope until the intervention and each participant will be asked to select an envelope that determine which group of intervention he will be assigned.
- Interventions: Grouping 84 patients who fulfill the inclusion criteria will be enrolled to the study. For every patient a tooth of complain which fulfill the inclusion criteria will be selected, so the total number of included teeth will be 84 teeth. Teeth will be classified into 4 groups according to the type of desensitizer used. Where in group 1 (G1) patients will be randomly assigned to "Resin-Based Desensitizer", in group 2 (G2) patients will be randomly assigned to "Laser Desensitizer", in group 3 (G3) patients will be randomly assigned to "Combination of Laser + Resin-Based Desensitizer", and in group 4 (G4) patients will be randomly assigned to "Fluoride-Based Desensitizer". For every patient, sensitivity test will be done using visual analogue scale immediately after application, three months after application and six months after application. Table 1 shows the variables of the study, and Table 2 shows the variables of the study. Each patient's name will be replaced with a case number within the group to protect the privacy of medical information and data of the patients. Clinical Procedures: Controlled air stimulus (Evaporative) will be applied on the tooth of complain, using dental syringe adjusted 40-65 psi directed perpendicular at a distance 1-3 mm from the exposed dentine. The patient should point out the degree of sensitivity on the VAS scale (0-10) chart the degree of pain. (VAS >5). Plastic card with figures of facial expressions expressing degree of pain, color coded, and numbers guided was used to ease the process of figuring out the degree of pain. For Resin-Based Desensitizer Group Cheek retractors and high-volume suction will be used for keeping dry and visible field as much as possible. The teeth will be thoroughly cleaned, and the surfaces will be air-dried. After proper dryness and with the aid of a micro-brush, resin-based desensitizer will be applied to the sensitive areas. Application time, and technique will be done according to manufacturer instructions. Then it will be cured using LED curing unit according to manufacturer instructions. For Laser Group The teeth will be thoroughly cleaned, and the surfaces will be air-dried. Low-power Diode laser will be used with the recommended parameters of the manufacturer for dentine hypersensitivity. The tip will be placed perpendicular to the tooth surface and moved over the lesion for the specified direction and time. For Combination Group Laser will be applied in the same parameters and technique as for the laser group, then it will be followed by the application of resin-based desensitizer following same instructions as the resin-based desensitizer group. For Fluoride-Based Group (Comparator) The teeth will be thoroughly cleaned, and the surfaces will be air-dried. The Fluoride-based varnish will be applied to the tooth structure using a micro-brush. Number and technique of application will be done according to manufacturer instructions. Post-Operative Instructions All patients will be instructed to avoid eating and drinking for an hour, avoid brushing or flossing for at least 4-6 hours.
- Outcomes:
Assessment of Outcome The post-operative hypersensitivity assessment will be performed for immediately, three months and six months after application using visual analogue scale (VAS).[19] It is a horizontal line graded from 1 to 10 with a descriptor at its far-left end indicating no pain, and at its far-right end indicating the worst possible pain. Illustration of facial expressions with color codes was added below the 10-centimeter line Visual Analog Scale.[20] (Figure 1). Assessment of the final outcome
- Conditions
- Dentin Hypersensitivity, Non-carious Cervical Lesions, Bioactive Glass Air Polishing, S-PRG, Dentin Hypersensitivity, Dentin Desensitizing Agents, Desensitization
- Being tested
- Resin-Based Desensitizer, Laser Desensitizer, Fluoride-Based Desensitizer
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resin-Based DesensitizerBiological
resin desensitizing agent
Laser DesensitizerDevice
Low-power Diode laser
Fluoride-Based DesensitizerBiological
Fluoride-based varnish
| Study group | Role | What they receive |
|---|---|---|
| Resin-Based Desensitizer | Active comparator | Not described Receives: Biological: Resin-Based Desensitizer |
| Laser Desensitizer | Active comparator | Not described Receives: Device: Laser Desensitizer |
| Combination of Laser + Resin-Based Desensitizer | Active comparator | Not described Receives: Biological: Resin-Based Desensitizer; Device: Laser Desensitizer |
| Fluoride-Based Desensitizer | Active comparator | Not described Receives: Biological: Fluoride-Based Desensitizer |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analogue scale (VAS)
post-operative hypersensitivity assessment with the visual analogue scale from 0-10 with 0 is the minimum sensitivity record and 10 is the maximum sensitivity record
Measured: 0,3,6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start1 Apr 2025
- Primary completion1 Oct 2025 (estimated)
- Study completion30 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dentin Hypersensitivity, Non-carious Cervical Lesions, Bioactive Glass Air Polishing, S-PRGStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 84 patients who fulfill the inclusion criteria will be enrolled to the study. For every patient a tooth of complain which fulfill the inclusion criteria will be selected, so the total number of included teeth will be 84 teeth. Teeth will be classified into 4 groups according to the type of desensitizer used. Where in group 1 (G1) patients will be randomly assigned to "Resin-Based Desensitizer", in group 2 (G2) patients will be randomly assigned to "Laser Desensitizer", in group 3 (G3) patients will be randomly assigned to "Combination of Laser + Resin-Based Desensitizer", and in group 4 (G4) patients will be randomly assigned to "Fluoride-Based Desensitizer". For every patient, sensitivity test will be done using visual analogue scale immediately after application, three months after application and six months after application. Table 1 shows the variables of the study,
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- British University In Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Shalaby, British University In Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07113847
- Sponsor's protocol ID
- 24-011
- Status last verified
- Aug 2025
- First submitted
- 3 Aug 2025
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All Data are available upon request
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Resin-Based Desensitizer and Laser, Compared to Fluoride Varnish in Management of Dentine Hypersensitivity in Non-carious Cervical Lesions
- ClinicalTrials.gov ID
- NCT07113847
- Acronym / sponsor ID
- 24-011
- Conditions
- Dentin Hypersensitivity, Non-carious Cervical Lesions, Bioactive Glass Air Polishing, S-PRG, Dentin Hypersensitivity, Dentin Desensitizing Agents, Desensitization
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 84 participants (actual)
- Lead sponsor
- British University In EgyptUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 11 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.
84 patients who fulfill the inclusion criteria will be enrolled to the study. For every patient a tooth of complain which fulfill the inclusion criteria will be selected, so the total number of included teeth will be 84 teeth. Teeth will be classified into 4 groups according to the type of desensitizer used. Where in group 1 (G1) patients will be randomly assigned to "Resin-Based Desensitizer", in group 2 (G2) patients will be randomly assigned to "Laser Desensitizer", in group 3 (G3) patients will be randomly assigned to "Combination of Laser + Resin-Based Desensitizer", and in group 4 (G4) patients will be randomly assigned to "Fluoride-Based Desensitizer". For every patient, sensitivity test will be done using visual analogue scale immediately after application, three months after application and six months after application. Table 1 shows the variables of the study, and Table 2 shows the variables of the study.
Each patient's name will be replaced with a case number within the group to protect the privacy of medical information and data of the patients.
Detailed description
- Participants Randomization and Allocation: Using computer generated randomization, the participants will be allocated randomly into four equal groups. The sequentially numbers that will be generated, will be placed in opaque envelope until the intervention and each participant will be asked to select an envelope that determine which group of intervention he will be assigned.
- Interventions: Grouping 84 patients who fulfill the inclusion criteria will be enrolled to the study. For every patient a tooth of complain which fulfill the inclusion criteria will be selected, so the total number of included teeth will be 84 teeth. Teeth will be classified into 4 groups according to the type of desensitizer used. Where in group 1 (G1) patients will be randomly assigned to "Resin-Based Desensitizer", in group 2 (G2) patients will be randomly assigned to "Laser Desensitizer", in group 3 (G3) patients will be randomly assigned to "Combination of Laser + Resin-Based Desensitizer", and in group 4 (G4) patients will be randomly assigned to "Fluoride-Based Desensitizer". For every patient, sensitivity test will be done using visual analogue scale immediately after application, three months after application and six months after application. Table 1 shows the variables of the study, and Table 2 shows the variables of the study. Each patient's name will be replaced with a case number within the group to protect the privacy of medical information and data of the patients. Clinical Procedures: Controlled air stimulus (Evaporative) will be applied on the tooth of complain, using dental syringe adjusted 40-65 psi directed perpendicular at a distance 1-3 mm from the exposed dentine. The patient should point out the degree of sensitivity on the VAS scale (0-10) chart the degree of pain. (VAS >5). Plastic card with figures of facial expressions expressing degree of pain, color coded, and numbers guided was used to ease the process of figuring out the degree of pain. For Resin-Based Desensitizer Group Cheek retractors and high-volume suction will be used for keeping dry and visible field as much as possible. The teeth will be thoroughly cleaned, and the surfaces will be air-dried. After proper dryness and with the aid of a micro-brush, resin-based desensitizer will be applied to the sensitive areas. Application time, and technique will be done according to manufacturer instructions. Then it will be cured using LED curing unit according to manufacturer instructions. For Laser Group The teeth will be thoroughly cleaned, and the surfaces will be air-dried. Low-power Diode laser will be used with the recommended parameters of the manufacturer for dentine hypersensitivity. The tip will be placed perpendicular to the tooth surface and moved over the lesion for the specified direction and time. For Combination Group Laser will be applied in the same parameters and technique as for the laser group, then it will be followed by the application of resin-based desensitizer following same instructions as the resin-based desensitizer group. For Fluoride-Based Group (Comparator) The teeth will be thoroughly cleaned, and the surfaces will be air-dried. The Fluoride-based varnish will be applied to the tooth structure using a micro-brush. Number and technique of application will be done according to manufacturer instructions. Post-Operative Instructions All patients will be instructed to avoid eating and drinking for an hour, avoid brushing or flossing for at least 4-6 hours.
- Outcomes:
Assessment of Outcome The post-operative hypersensitivity assessment will be performed for immediately, three months and six months after application using visual analogue scale (VAS).[19] It is a horizontal line graded from 1 to 10 with a descriptor at its far-left end indicating no pain, and at its far-right end indicating the worst possible pain. Illustration of facial expressions with color codes was added below the 10-centimeter line Visual Analog Scale.[20] (Figure 1). Assessment of the final outcome
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- 84 patients who fulfill the inclusion criteria will be enrolled to the study. For every patient a tooth of complain which fulfill the inclusion criteria will be selected, so the total number of included teeth will be 84 teeth. Teeth will be classified into 4 groups according to the type of desensitizer used. Where in group 1 (G1) patients will be randomly assigned to "Resin-Based Desensitizer", in group 2 (G2) patients will be randomly assigned to "Laser Desensitizer", in group 3 (G3) patients will be randomly assigned to "Combination of Laser + Resin-Based Desensitizer", and in group 4 (G4) patients will be randomly assigned to "Fluoride-Based Desensitizer". For every patient, sensitivity test will be done using visual analogue scale immediately after application, three months after application and six months after application. Table 1 shows the variables of the study,
| Arm | Type | Receives |
|---|---|---|
| Resin-Based Desensitizer | Active comparator | Biological: Resin-Based Desensitizer |
| Laser Desensitizer | Active comparator | Device: Laser Desensitizer |
| Combination of Laser + Resin-Based Desensitizer | Active comparator | Biological: Resin-Based Desensitizer, Device: Laser Desensitizer |
| Fluoride-Based Desensitizer | Active comparator | Biological: Fluoride-Based Desensitizer |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Males or Females
- 18 -50 years.
- Not received antibiotic therapy for 1 month before sampling.
- Good oral hygiene.
- Co-operative patients approving the trial.
Key exclusion criteria (11 listed)
- Pregnancy.
- Systemic disease or severe medical complications.
- Patients who did any periodontal surgeries within the previous 6 months.
- Patients with bad oral hygiene.
- Patients who are allergic to any ingredients used in the study.
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 |
|---|---|---|
| Resin-Based Desensitizerresin desensitizing agent | Biological | Combination of Laser + Resin-Based Desensitizer, Resin-Based Desensitizer |
| Laser DesensitizerLow-power Diode laser | Device | Combination of Laser + Resin-Based Desensitizer, Laser Desensitizer |
| Fluoride-Based DesensitizerFluoride-based varnish | Biological | Fluoride-Based Desensitizer |
Primary outcome
visual analogue scale (VAS)
Time frame: 0,3,6 months
post-operative hypersensitivity assessment with the visual analogue scale from 0-10 with 0 is the minimum sensitivity record and 10 is the maximum sensitivity record
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 13 Aug 2025.
- Individual participant dataSharing planned: Yes. All Data are available upon request
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Resin-Based Desensitizer, Laser Desensitizer and Fluoride-Based Desensitizer in people with Dentin Hypersensitivity, Non-carious Cervical Lesions, Bioactive Glass Air Polishing, S-PRG and Dentin Hypersensitivity, run by British University In Egypt at 1 site in Egypt.
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 9 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
visual analogue scale (VAS) (time frame: 0,3,6 months). 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 13 Aug 2025.