Dentin HypersensitivityNCT07063433
Effect of Gluma and Bioactive Glass Desensitizers in Treatment of Dentin Hypersensitivity in Cervical Non-Carious Lesions
A study testing Gluma Desensitizer, Bioactive glass and Fluoride varnish in people with Dentin Hypersensitivity, run by British University In Egypt at 1 site in Egypt.
Trial summary
Type of study: (A Randomized Controlled Clinical Trial) Aim :The aim of this randomized controlled clinical trial is to evaluate the effect of Gluma, Bioactive Glass and combination of both, compared to Flouride Varnish on the treatment of dentin hypersensitivity of cervical non-carious lesions in adult Population… Read more about this study
- Who is it for?
- Ages 21 to 40 years
- Conditions the study is for
- Dentin Hypersensitivity
- What is being tested?
- Gluma Desensitizer, Bioactive glass and Fluoride varnish
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Feb 2025to 15 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient's age ranges from 21- 40 years old.
- Males or Females
- Co-operative Patients approving the trial.
- Good oral hygiene
- Not received antibiotic therapy for 1 month before sampling
Who cannot join
- Lack of compliance
- Patients with bad oral hygiene
- Patients who are allergic to any ingredients used in the study.
- Medically compromised patients with systemic complications that would alter the treatment.
- Patients who did any periodontal surgeries within the previous 6 months.
- Inability to give informed consent.
- Xerostomia.
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Gluma and Bioactive Glass in Treatment of Dentin Hypersensitivity in Cervical Lesions (A Randomized Clinical Trial)
Type of study: (A Randomized Controlled Clinical Trial)
Aim :The aim of this randomized controlled clinical trial is to evaluate the effect of Gluma, Bioactive Glass and combination of both, compared to Flouride Varnish on the treatment of dentin hypersensitivity of cervical non-carious lesions in adult Population over six months.
Read more
The study will enroll 40 patients meeting the inclusion criteria. Each patient will contribute one tooth with complaints that meet the inclusion criteria, resulting in a total of 40 included teeth. The teeth will be categorized into Four groups based on the type of desensitizer used.
- Group 1 (G1); patients will be randomly assigned to Gluma.
- Group 2 (G2); patients will be randomly assigned to Bioactive Glass Powder.
- Group 3 (G3); patients will be randomly assigned to combination of both materials, Gluma and Bioactive Glass powder
- Group 4 (G4); patients will be randomly assigned to the Fluoride Varnish. For each patient, a sensitivity test will be conducted using a Visual Analog Scale immediately after desensitizer application, as well as at three months and six months post-application.
Clinical procedures:
The study will involve applying a controlled air stimulus (evaporative) to the complaining tooth. This will be done using a dental syringe adjusted to 40-65 psi, directed perpendicular at a distance of 1-3 mm from the exposed dentin. Subsequently, the patient will indicate the level of sensitivity on a Visual Analog Scale (VAS) chart ranging from 0 to 10, with a focus on instances where the VAS score exceeds 4. To facilitate the patient's expression of pain intensity, a plastic card featuring figures with facial expressions, color-coded, and numbered, will be utilized. This visual aid aims to streamline the process of discerning and recording the degree of pain experienced by the patient.
For Gluma group
Each sensitive tooth will be cleaned with a polishing paste, rinsed with water and air dried. Two coats of Gluma Desensitizer will be applied using a disposable brush applicator following the manufacturer's instructions and left untouched for 30-60 minutes.
For Bioactive Glass group :
To maintain a dry and clear field of vision, cheek retractors and high-volume suction will be employed during the procedure. High-volume suction, featuring a 45-degree beveled end, will be strategically positioned at the incisal or occlusal part of the teeth. This placement is designed to efficiently remove any particles, preventing the patient from swallowing them and minimizing the risk of minor injuries resulting from a forceful powder and water stream. The NSK Prophymate Neo will be utilized to dispense Sylc dry powder, which comprises calcium sodium phosphosilicate, onto the sensitive areas. The air stream will be carefully adjusted to 40-46 psi in accordance with the manufacturer's instructions. The handpiece will be maintained at a constant distance of 3-4 mm from the tooth surface, positioned at 60-80 degrees on the buccal surfaces. To prevent gingival injury, the tip of the handpiece will be directed incisally during application. The powder will be applied for 5-10 seconds per tooth, using a circular motion.
For the combined group (Bioactive Glass + Gluma) A combination of both Gluma and bioactive glass powder will be applied to the assigned teeth.
For the comparator group :
The teeth will undergo a thorough cleaning process using a polishing brush without any paste, and the surfaces will be subsequently air-dried. The application of a single dose of Bifluorid 10 (by VOCO) will be carried out using a micro brush. A thin coat of varnish will be applied to the tooth surface, and it will be left in place for 10-20 seconds before being air-dried. This procedure is designed to facilitate the effective application of the desensitizing agent.
- Conditions
- Dentin Hypersensitivity
- Being tested
- Gluma Desensitizer, Bioactive glass, Fluoride varnish
- Keywords
- dentin hypersensitivity, gluma, Bioactive glass, fluoride varnish, VAS, non carious lesions, cervical non carious lesions
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gluma DesensitizerDrug
Each sensitive tooth will be cleaned with a polishing paste, rinsed with water and air dried. Two coats of Gluma Desensitizer will be applied using a disposable brush applicator following the manufacturer's instructions and left untouched for 30-60 minutes.
Bioactive glassDrug
Also called Sylc
The NSK Prophymate Neo will be utilized to dispense Sylc dry powder, which comprises calcium sodium phosphosilicate, onto the sensitive areas. The air stream will be carefully adjusted to 40-46 psi in accordance with the manufacturer's instructions. The handpiece will be maintained at a constant distance of 3-4 mm from the tooth surface, positioned at 60-80 degrees on the buccal surfaces. The powder will be applied for 5-10 seconds per tooth, using a circular motion.
Fluoride varnishDrug
Also called Bifluorid 10
The application of a single dose of Bifluorid 10 (by VOCO) will be carried out using a micro brush. A thin coat of varnish will be applied to the tooth surface, and it will be left in place for 10-20 seconds before being air-dried.
| Study group | Role | What they receive |
|---|---|---|
| Gluma Group | Active comparator | Each sensitive tooth will be cleaned with a polishing paste, rinsed with water and air dried. Two coats of Gluma Desensitizer will be applied using a disposable brush applicator following the manufacturer's instructions and left untouched for 30-60 minutes. Receives: Drug: Gluma Desensitizer |
| Bioactive Glass Group | Active comparator | To maintain a dry and clear field of vision, cheek retractors and high-volume suction will be employed during the procedure. High-volume suction, featuring a 45-degree beveled end, will be strategically positioned at the incisal or occlusal part of the teeth. This placement is designed to efficiently remove any particles, preventing the patient from swallowing them and minimizing the risk of minor injuries resulting from a forceful powder and water stream. The NSK Prophymate Neo will be utilized to dispense Sylc dry powder, which comprises calcium sodium phosphosilicate, onto the sensitive areas. The air stream will be carefully adjusted to 40-46 psi in accordance with the manufacturer's instructions. The handpiece will be maintained at a constant distance of 3-4 mm from the tooth surface, positioned at 60-80 degrees on the buccal surfaces. To prevent gingival injury, the tip of the handpiece will be directed incisally during application. The powder will be applied for 5-10 seconds pe Receives: Drug: Bioactive glass |
| Combination of Gluma and Bioactive glass | Active comparator | A combination of both Gluma and bioactive glass powder will be applied to the assigned teeth. Receives: Drug: Gluma Desensitizer; Drug: Bioactive glass |
| Fluoride Varnish | Active comparator | The teeth will undergo a thorough cleaning process using a polishing brush without any paste, and the surfaces will be subsequently air-dried. The application of a single dose of Bifluorid 10 (by VOCO) will be carried out using a micro brush. A thin coat of varnish will be applied to the tooth surface, and it will be left in place for 10-20 seconds before being air-dried. This procedure is designed to facilitate the effective application of the desensitizing agent. Receives: Drug: Fluoride varnish |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative hypersensitivity assessment using Visaul
Post-operative hypersensitivity assessment will be conducted immediately after application, as well as at three months and six months post-treatment. The evaluation will utilize the Visual Analog Scale (VAS) as described by Van den Breemer et al. (2019) . This scale is represented by 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. Additionally, facial expressions with color codes will be illustrated below the 10-centimeter line on the Visual Analog Scale, as outlined by Burrow et al. (2009). This approach provides a comprehensive and visual means for patients to express and quantify their post-operative hypersensitivity levels.
Measured: From enrollment to the end of treatment at 6 months .
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start3 Feb 2025
- Primary completion22 May 2025
- Study completion15 Nov 2025
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.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- British University In Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Katarya, British University In Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07063433
- Sponsor's protocol ID
- 24-012
- Status last verified
- Feb 2026
- First submitted
- 25 Jun 2025
- Last updated
- 6 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Gluma and Bioactive Glass in Treatment of Dentin Hypersensitivity in Cervical Lesions (A Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT07063433
- Acronym / sponsor ID
- 24-012
- Conditions
- Dentin Hypersensitivity
- Keywords
- dentin hypersensitivity, gluma, Bioactive glass, fluoride varnish, VAS, non carious lesions, cervical non carious lesions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- British University In EgyptUniversity, hospital or other
- Study start
- 3 Feb 2025 (actual)
- Primary completion
- 22 May 2025 (actual)
- Study completion
- 15 Nov 2025 (actual)
- First posted
- 14 Jul 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.
Type of study: (A Randomized Controlled Clinical Trial)
Aim :The aim of this randomized controlled clinical trial is to evaluate the effect of Gluma, Bioactive Glass and combination of both, compared to Flouride Varnish on the treatment of dentin hypersensitivity of cervical non-carious lesions in adult Population over six months.
The study will enroll 40 patients meeting the inclusion criteria. Each patient will contribute one tooth with complaints that meet the inclusion criteria, resulting in a total of 40 included teeth. The teeth will be categorized into Four groups based on the type of desensitizer used.
- Group 1 (G1); patients will be randomly assigned to Gluma.
- Group 2 (G2); patients will be randomly assigned to Bioactive Glass Powder.
- Group 3 (G3); patients will be randomly assigned to combination of both materials, Gluma and Bioactive Glass powder
- Group 4 (G4); patients will be randomly assigned to the Fluoride Varnish. For each patient, a sensitivity test will be conducted using a Visual Analog Scale immediately after desensitizer application, as well as at three months and six months post-application.
Clinical procedures:
The study will involve applying a controlled air stimulus (evaporative) to the complaining tooth. This will be done using a dental syringe adjusted to 40-65 psi, directed perpendicular at a distance of 1-3 mm from the exposed dentin. Subsequently, the patient will indicate the level of sensitivity on a Visual Analog Scale (VAS) chart ranging from 0 to 10, with a focus on instances where the VAS score exceeds 4. To facilitate the patient's expression of pain intensity, a plastic card featuring figures with facial expressions, color-coded, and numbered, will be utilized. This visual aid aims to streamline the process of discerning and recording the degree of pain experienced by the patient.
For Gluma group
Each sensitive tooth will be cleaned with a polishing paste, rinsed with water and air dried. Two coats of Gluma Desensitizer will be applied using a disposable brush applicator following the manufacturer's instructions and left untouched for 30-60 minutes.
For Bioactive Glass group :
To maintain a dry and clear field of vision, cheek retractors and high-volume suction will be employed during the procedure. High-volume suction, featuring a 45-degree beveled end, will be strategically positioned at the incisal or occlusal part of the teeth. This placement is designed to efficiently remove any particles, preventing the patient from swallowing them and minimizing the risk of minor injuries resulting from a forceful powder and water stream. The NSK Prophymate Neo will be utilized to dispense Sylc dry powder, which comprises calcium sodium phosphosilicate, onto the sensitive areas. The air stream will be carefully adjusted to 40-46 psi in accordance with the manufacturer's instructions. The handpiece will be maintained at a constant distance of 3-4 mm from the tooth surface, positioned at 60-80 degrees on the buccal surfaces. To prevent gingival injury, the tip of the handpiece will be directed incisally during application. The powder will be applied for 5-10 seconds per tooth, using a circular motion.
For the combined group (Bioactive Glass + Gluma) A combination of both Gluma and bioactive glass powder will be applied to the assigned teeth.
For the comparator group :
The teeth will undergo a thorough cleaning process using a polishing brush without any paste, and the surfaces will be subsequently air-dried. The application of a single dose of Bifluorid 10 (by VOCO) will be carried out using a micro brush. A thin coat of varnish will be applied to the tooth surface, and it will be left in place for 10-20 seconds before being air-dried. This procedure is designed to facilitate the effective application of the desensitizing agent.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Gluma Group | Active comparator | Drug: Gluma DesensitizerEach sensitive tooth will be cleaned with a polishing paste, rinsed with water and air dried. Two coats of Gluma Desensitizer will be applied using a disposable brush applicator following the manufacturer's instructions and left untouched for 30-60 minutes. |
| Bioactive Glass Group | Active comparator | Drug: Bioactive glassTo maintain a dry and clear field of vision, cheek retractors and high-volume suction will be employed during the procedure. High-volume suction, featuring a 45-degree beveled end, will be strategically positioned at the incisal or occlusal part of the teeth. This placement is designed to efficiently remove any particles, preventing the patient from swallowing them and minimizing the risk of minor injuries resulting from a forceful powder and water stream. The NSK Prophymate Neo will be utilized to dispense Sylc dry powder, which comprises calcium sodium phosphosilicate, onto the sensitive areas. The air stream will be carefully adjusted to 40-46 psi in accordance with the manufacturer's instructions. The handpiece will be maintained at a constant distance of 3-4 mm from the tooth surface, positioned at 60-80 degrees on the buccal surfaces. To prevent gingival injury, the tip of the handpiece will be directed incisally during application. The powder will be applied for 5-10 seconds pe |
| Combination of Gluma and Bioactive glass | Active comparator | Drug: Gluma Desensitizer, Drug: Bioactive glassA combination of both Gluma and bioactive glass powder will be applied to the assigned teeth. |
| Fluoride Varnish | Active comparator | Drug: Fluoride varnishThe teeth will undergo a thorough cleaning process using a polishing brush without any paste, and the surfaces will be subsequently air-dried. The application of a single dose of Bifluorid 10 (by VOCO) will be carried out using a micro brush. A thin coat of varnish will be applied to the tooth surface, and it will be left in place for 10-20 seconds before being air-dried. This procedure is designed to facilitate the effective application of the desensitizing agent. |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patient's age ranges from 21- 40 years old.
- Males or Females
- Co-operative Patients approving the trial.
- Good oral hygiene
- Not received antibiotic therapy for 1 month before sampling
Key exclusion criteria (8 listed)
- Lack of compliance
- Patients with bad oral hygiene
- Patients who are allergic to any ingredients used in the study.
- Medically compromised patients with systemic complications that would alter the treatment.
- Patients who did any periodontal surgeries within the previous 6 months.
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 |
|---|---|---|
| Gluma DesensitizerEach sensitive tooth will be cleaned with a polishing paste, rinsed with water and air dried. Two coats of Gluma Desensitizer will be applied using a disposable brush applicator following the manufacturer's instructions and left untouched for 30-60 minutes. | Drug | Combination of Gluma and Bioactive glass, Gluma Group |
| Bioactive glassAlso: SylcThe NSK Prophymate Neo will be utilized to dispense Sylc dry powder, which comprises calcium sodium phosphosilicate, onto the sensitive areas. The air stream will be carefully adjusted to 40-46 psi in accordance with the manufacturer's instructions. The handpiece will be maintained at a constant distance of 3-4 mm from the tooth surface, positioned at 60-80 degrees on the buccal surfaces. The powder will be applied for 5-10 seconds per tooth, using a circular motion. | Drug | Bioactive Glass Group, Combination of Gluma and Bioactive glass |
| Fluoride varnishAlso: Bifluorid 10The application of a single dose of Bifluorid 10 (by VOCO) will be carried out using a micro brush. A thin coat of varnish will be applied to the tooth surface, and it will be left in place for 10-20 seconds before being air-dried. | Drug | Fluoride Varnish |
Primary outcome
Post-operative hypersensitivity assessment using Visaul
Time frame: From enrollment to the end of treatment at 6 months .
Post-operative hypersensitivity assessment will be conducted immediately after application, as well as at three months and six months post-treatment. The evaluation will utilize the Visual Analog Scale (VAS) as described by Van den Breemer et al. (2019) . This scale is represented by 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. Additionally, facial expressions with color codes will be illustrated below the 10-centimeter line on the Visual Analog Scale, as outlined by Burrow et al. (2009). This approach provides a comprehensive and visual means for patients to express and quantify their post-operative hypersensitivity levels.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
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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. 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 study testing Gluma Desensitizer, Bioactive glass and Fluoride varnish in people with 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 5 inclusion and 8 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: finished, as of the sponsor's last update on 6 Feb 2026. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Post-operative hypersensitivity assessment using Visaul (time frame: From enrollment to the end of treatment at 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 6 Feb 2026.