Dentin HypersensitivityNCT07068724
Management of Dentin Hypersensitivity in Patients With Periodontitis
A study testing Gluma Desensitizer and ER:CR;YSGG laser combination and Er,Cr:YSGG laser in people with Dentin Hypersensitivity, run by Trakya University at 1 site in Turkey (Türkiye).
Trial summary
A total of 62 patients diagnosed with Stage III-IV periodontitis underwent non-surgical periodontal therapy. At 24 hours post-treatment, patients were recalled to the clinic for reassessment using air-stimulated Visual Analog Scale (VAS) and Schiff Cold Air Sensitivity Scale measurements. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Dentin Hypersensitivity
- What is being tested?
- Gluma Desensitizer and ER:CR;YSGG laser combination and Er,Cr:YSGG laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Apr 2025to 20 Oct 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. No reported or clinically detected dentin hypersensitivity prior to the initiation of non-surgical periodontal therapy.
- 2. Presence of at least five teeth with probing pocket depths (PPD) ≥6 mm. 3. Systemically healthy individuals with no history of systemic diseases that may interfere with periodontal outcomes.
- 4. Absence of deep restorations or visible cracks in the teeth adjacent to those selected for hypersensitivity evaluation.
- 5. No previous treatment for dentin hypersensitivity and no current use of desensitizing toothpaste or products.
- 6. Clinical diagnosis of Stage III or IV periodontitis, involving periodontal support loss in more than 30% of teeth.
- 7. A clinical attachment level (CAL) ≥5 mm and radiographic evidence of bone loss extending to the mid-root level.
- 8. Age 18 years or older at the time of enrollment
Who cannot join
- 1. Use of antibiotics or analgesic medications at the time of screening or during the course of the study.
- 2. Pregnancy or breastfeeding. 3. Receipt of periodontal therapy within the preceding 6 months. 4. Smoking history of 10 or more cigarettes per day. 5. Regular use of desensitizing toothpaste or other anti-hypersensitivity agents.
- 6. Presence of parafunctional oral habits (e.g., bruxism, clenching). 7. Existence of non-carious cervical lesions such as erosion, attrition, or abrasion on study or adjacent teeth.
- 8. High frequency of acidic dietary intake. 9. Inability to meet hypersensitivity perception thresholds following non-surgical periodontal therapy, defined as a Visual Analog Scale (VAS) score >4 and Schiff Cold Air Sensitivity Scale score of 2 or 3.
- 10. Contraindications to the use of Er,Cr:YSGG laser therapy, including but not limited to: known allergies to local or topical anesthetics, presence of cardiac devices (e.g., pacemakers or implantable defibrillators), respiratory disease, bleeding disorders, or immunosuppressive conditions. In such cases, written clearance from a physician is required.
- 11. Known or suspected allergy to any component of the Gluma Desensitizer, specifically hydroxymethyl methacrylate or glutaraldehyde.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Chemical and Laser Desensitization Approaches for Managing Dentin Hypersensitivity After Non-Surgical Periodontal Therapy: A Randomized Clinical Trial
A total of 62 patients diagnosed with Stage III-IV periodontitis underwent non-surgical periodontal therapy. At 24 hours post-treatment, patients were recalled to the clinic for reassessment using air-stimulated Visual Analog Scale (VAS) and Schiff Cold Air Sensitivity Scale measurements. Two teeth per patient were randomly selected based on a VAS score greater than 4 and a Schiff score of 2 or 3. A total of 52 patients who met the inclusion criteria were included in the study. This study was designed as a randomized, parallel clinical trial. The 52 patients were randomly allocated into three treatment groups: Group 1 received the desensitizing agent Gluma, Group 2 underwent Er,Cr:YSGG laser treatment, and Group 3 received a combination of Gluma and Er,Cr:YSGG laser therapy. Desensitizing agent applications were performed according to the designated treatment protocols.To assess changes in dentin hypersensitivity over time, patients were recalled for follow-up evaluations at 1 week, 2 weeks, 1 month, 2 months and 6 months post-application. The 6-month follow-up of the study was completed with 48 patients (16 patients for each study group). At each follow-up visit, air-stimulated VAS and Schiff scale measurements were employed to quantify hypersensitivity levels.
- Conditions
- Dentin Hypersensitivity
- Being tested
- Gluma Desensitizer and ER:CR;YSGG laser combination, Er,Cr:YSGG laser
- 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 Desensitizer and ER:CR;YSGG laser combinationCombination product
Participants in this group received both treatments: Gluma was applied using the same method as in Gluma, followed by Er,Cr:YSGG laser therapy using the same parameters and technique as in laser.
Er,Cr:YSGG laserDevice
Participants received Er,Cr:YSGG laser treatment (Water-Lase iPlusTM; Biolase® Technology Inc., Irvine, CA, USA). Laser parameters were set as follows: 2780 nm wavelength, 0.25 W power, 20 Hz frequency, 140 μs pulse duration, and 30 seconds exposure time. The MZ6 tip (660 μm diameter, 6 mm length, 1 mm spot size) was used in non-contact mode from a 1 mm distance, perpendicular to the dentin surface, with 0% water and 10% air spray. All laser applications followed international safety standards and protocols.
| Study group | Role | What they receive |
|---|---|---|
| Gluma applied group | No intervention | Participants received Gluma Desensitizer (containing glutaraldehyde) applied to the sensitive teeth. Following isolation of the target teeth with cotton rolls, Gluma was applied using a microbrush in a rubbing motion for 30 seconds. The dentin surface was then air-dried until it lost its shine, followed by rinsing with water for 60 seconds. |
| laser applied group | Experimental | Participants received Er,Cr:YSGG laser treatment (Water-Lase iPlusTM; Biolase® Technology Inc., Irvine, CA, USA). Laser parameters were set as follows: 2780 nm wavelength, 0.25 W power, 20 Hz frequency, 140 μs pulse duration, and 30 seconds exposure time. The MZ6 tip (660 μm diameter, 6 mm length, 1 mm spot size) was used in non-contact mode from a 1 mm distance, perpendicular to the dentin surface, with 0% water and 10% air spray. All laser applications followed international safety standards and protocols. Receives: Device: Er,Cr:YSGG laser |
| Combination applied group | Experimental | Participants in this group received both treatments: Gluma was applied using the same method as in Gluma, followed by Er,Cr:YSGG laser therapy using the same parameters and technique as in laser. Receives: Combination Product: Gluma Desensitizer and ER:CR;YSGG laser combination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in hypersensitivity rate
Combination of Gluma and Laser application can have an synergistic effect on hypersensitivity rate
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start10 Apr 2025
- Primary completion10 Oct 2025
- Study completion20 Oct 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trakya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ece AÇIKGÖZ ALPARSLAN, Trakya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07068724
- Sponsor's protocol ID
- 2024-KAEK-06
- Status last verified
- Oct 2025
- First submitted
- 10 Apr 2025
- Last updated
- 16 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The datasets generated and/or analysed during the current study are not publicly available due to their sensitive and identifying nature, as well as the informed consent agreements made with participants but are available from the corresponding author on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chemical and Laser Desensitization Approaches for Managing Dentin Hypersensitivity After Non-Surgical Periodontal Therapy: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07068724
- Acronym / sponsor ID
- 2024-KAEK-06
- Conditions
- Dentin Hypersensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Trakya UniversityUniversity, hospital or other
- Study start
- 10 Apr 2025 (actual)
- Primary completion
- 10 Oct 2025 (actual)
- Study completion
- 20 Oct 2025 (actual)
- First posted
- 16 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.
A total of 62 patients diagnosed with Stage III-IV periodontitis underwent non-surgical periodontal therapy. At 24 hours post-treatment, patients were recalled to the clinic for reassessment using air-stimulated Visual Analog Scale (VAS) and Schiff Cold Air Sensitivity Scale measurements. Two teeth per patient were randomly selected based on a VAS score greater than 4 and a Schiff score of 2 or 3. A total of 52 patients who met the inclusion criteria were included in the study. This study was designed as a randomized, parallel clinical trial. The 52 patients were randomly allocated into three treatment groups: Group 1 received the desensitizing agent Gluma, Group 2 underwent Er,Cr:YSGG laser treatment, and Group 3 received a combination of Gluma and Er,Cr:YSGG laser therapy. Desensitizing agent applications were performed according to the designated treatment protocols.To assess changes in dentin hypersensitivity over time, patients were recalled for follow-up evaluations at 1 week, 2 weeks, 1 month, 2 months and 6 months post-application. The 6-month follow-up of the study was completed with 48 patients (16 patients for each study group). At each follow-up visit, air-stimulated VAS and Schiff scale measurements were employed to quantify hypersensitivity levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Gluma applied group | No intervention | –Participants received Gluma Desensitizer (containing glutaraldehyde) applied to the sensitive teeth. Following isolation of the target teeth with cotton rolls, Gluma was applied using a microbrush in a rubbing motion for 30 seconds. The dentin surface was then air-dried until it lost its shine, followed by rinsing with water for 60 seconds. |
| laser applied group | Experimental | Device: Er,Cr:YSGG laserParticipants received Er,Cr:YSGG laser treatment (Water-Lase iPlusTM; Biolase® Technology Inc., Irvine, CA, USA). Laser parameters were set as follows: 2780 nm wavelength, 0.25 W power, 20 Hz frequency, 140 μs pulse duration, and 30 seconds exposure time. The MZ6 tip (660 μm diameter, 6 mm length, 1 mm spot size) was used in non-contact mode from a 1 mm distance, perpendicular to the dentin surface, with 0% water and 10% air spray. All laser applications followed international safety standards and protocols. |
| Combination applied group | Experimental | Combination Product: Gluma Desensitizer and ER:CR;YSGG laser combinationParticipants in this group received both treatments: Gluma was applied using the same method as in Gluma, followed by Er,Cr:YSGG laser therapy using the same parameters and technique as in laser. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 1. No reported or clinically detected dentin hypersensitivity prior to the initiation of non-surgical periodontal therapy.
- 2. Presence of at least five teeth with probing pocket depths (PPD) ≥6 mm. 3. Systemically healthy individuals with no history of systemic diseases that may interfere with periodontal outcomes.
- 4. Absence of deep restorations or visible cracks in the teeth adjacent to those selected for hypersensitivity evaluation.
- 5. No previous treatment for dentin hypersensitivity and no current use of desensitizing toothpaste or products.
- 6. Clinical diagnosis of Stage III or IV periodontitis, involving periodontal support loss in more than 30% of teeth.
Key exclusion criteria (6 listed)
- 1. Use of antibiotics or analgesic medications at the time of screening or during the course of the study.
- 2. Pregnancy or breastfeeding. 3. Receipt of periodontal therapy within the preceding 6 months. 4. Smoking history of 10 or more cigarettes per day. 5. Regular use of desensitizing toothpaste or other anti-hypersensitivity agents.
- 6. Presence of parafunctional oral habits (e.g., bruxism, clenching). 7. Existence of non-carious cervical lesions such as erosion, attrition, or abrasion on study or adjacent teeth.
- 8. High frequency of acidic dietary intake. 9. Inability to meet hypersensitivity perception thresholds following non-surgical periodontal therapy, defined as a Visual Analog Scale (VAS) score >4 and Schiff Cold Air Sensitivity Scale score of 2 or 3.
- 10. Contraindications to the use of Er,Cr:YSGG laser therapy, including but not limited to: known allergies to local or topical anesthetics, presence of cardiac devices (e.g., pacemakers or implantable defibrillators), respiratory disease, bleeding disorders, or immunosuppressive conditions. In such cases, written clearance from a physician is required.
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 Desensitizer and ER:CR;YSGG laser combinationParticipants in this group received both treatments: Gluma was applied using the same method as in Gluma, followed by Er,Cr:YSGG laser therapy using the same parameters and technique as in laser. | Combination product | Combination applied group |
| Er,Cr:YSGG laserParticipants received Er,Cr:YSGG laser treatment (Water-Lase iPlusTM; Biolase® Technology Inc., Irvine, CA, USA). Laser parameters were set as follows: 2780 nm wavelength, 0.25 W power, 20 Hz frequency, 140 μs pulse duration, and 30 seconds exposure time. The MZ6 tip (660 μm diameter, 6 mm length, 1 mm spot size) was used in non-contact mode from a 1 mm distance, perpendicular to the dentin surface, with 0% water and 10% air spray. All laser applications followed international safety standards and protocols. | Device | laser applied group |
Primary outcome
Decrease in hypersensitivity rate
Time frame: 6 months
Combination of Gluma and Laser application can have an synergistic effect on hypersensitivity rate
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 16 Dec 2025.
- Individual participant dataSharing planned: Yes. The datasets generated and/or analysed during the current study are not publicly available due to their sensitive and identifying nature, as well as the informed consent agreements made with participants but are available from the corresponding author on reasonable request.
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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 and ER:CR;YSGG laser combination and Er,Cr:YSGG laser in people with Dentin Hypersensitivity, run by Trakya University at 1 site in Turkey (Türkiye).
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 6 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 16 Dec 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 Turkey (Türkiye). 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?
Decrease in hypersensitivity rate (time frame: 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 16 Dec 2025.