Dentine HypersensitivityNCT07647861
Efficacy of Lasers, Propolis-Based Agent, and Sham for Dentine Hypersensitivity
A study testing Nd:YAG Laser Application, Diode Laser Application and Herbal Propolis-Based Dentin Barrier Agent in people with Dentine Hypersensitivity, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
Dentine hypersensitivity is a common clinical problem. Although Nd:YAG lasers, diode lasers, and topical desensitizing agents are widely utilized, long-term comparative evidence regarding their clinical efficacy remains limited. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Dentine Hypersensitivity
- What is being tested?
- Nd:YAG Laser Application, Diode Laser Application and Herbal Propolis-Based Dentin Barrier Agent
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2025to 10 Jun 2026
- 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
- Patients aged between 18 and 65 years.
- Presence of at least two hypersensitive teeth.
- Visual Analog Scale (VAS) score of 4 or higher (VAS >= 4) following stimulus.
- Schiff Cold Air Sensitivity Scale score of 2 or higher (Schiff >= 2).
- Presence of vital teeth in the target area.
- Patient is willing and able to provide written informed consent prior to study initiation.
Who cannot join
- Pregnancy or lactation.
- Presence of active periodontal disease in the target area.
- Teeth with dental caries, deep restorations, or cracked tooth syndrome.
- Endodontically treated teeth.
- History of allergy or hypersensitivity related to the materials, products, or chemical agents used in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ondokuz Mayıs University, Faculty of Dentistry, Department of Periodontology
Samsun, Samsun, 55270
About this study
Official title: Comparison of Nd:YAG Laser, Diode Laser, Herbal Propolis-Based Dentin Barrier Agent, and Sham Application in the Treatment of Dentine Hypersensitivity: A Randomized Controlled Clinical Trial
Dentine hypersensitivity is a common clinical problem. Although Nd:YAG lasers, diode lasers, and topical desensitizing agents are widely utilized, long-term comparative evidence regarding their clinical efficacy remains limited. This prospective, randomized, parallel-arm, evaluator-blind, sham-controlled clinical trial evaluated and compared the 12-month clinical performance of an Nd:YAG laser, a diode laser, a herbal propolis-based dentin barrier agent, and a sham application.
Read the detailed description
This study was conducted as a prospective, randomized, parallel-arm, evaluator-blinded, sham-controlled clinical trial to evaluate and compare the clinical efficacy of four different treatment modalities for dentine hypersensitivity over a 6-month follow-up period.
A total of 140 patients who met the eligibility criteria were enrolled and randomly allocated into four equal groups (n=35 per group) using a block randomization method with a 1:1:1:1 allocation ratio. The intervention groups were assigned as follows:
Group 1 received Nd:YAG laser application.
Group 2 received Diode laser application.
Group 3 received a topical application of a herbal propolis-based dentin barrier agent.
Group 4 received a sham (placebo) application to simulate the treatment experience without delivering any active laser or therapeutic agent benefits.
Clinical evaluations were performed at baseline, immediately post-treatment, 1 week, 1 month, 3 months, and 6 months. The primary outcome was the change in pain intensity measured by the Visual Analog Scale (VAS) following a controlled air blast stimulus from baseline to 6 months. Secondary outcomes included changes in the Schiff Cold Air Sensitivity Scale, tactile sensitivity scores, patient satisfaction levels, the documentation of any adverse events, and the need for additional treatment during the 6-month period. To ensure objectivity, all clinical assessments and statistical analyses were performed by researchers who were fully blinded to the treatment allocations.
- Conditions
- Dentine Hypersensitivity
- Being tested
- Nd:YAG Laser Application, Diode Laser Application, Herbal Propolis-Based Dentin Barrier Agent, Sham Application
- Keywords
- Dentine Hypersensitivity, Nd:YAG Laser, Diode Laser, Propolis, Lasers in Dentistry, Dentin Desensitizing Agents
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nd:YAG Laser ApplicationDevice
Nd:YAG laser application performed for the treatment of dentine hypersensitivity.
Diode Laser ApplicationDevice
Diode laser application performed for the treatment of dentine hypersensitivity.
Herbal Propolis-Based Dentin Barrier AgentOther
Topical application of a herbal propolis-based dentin barrier agent.
Sham ApplicationOther
Placebo/sham procedure to simulate treatment without delivering active laser or therapeutic agent benefits
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Nd:YAG Laser | Experimental | Participants assigned to this group received Nd:YAG laser application targeted at the hypersensitive teeth to achieve desensitization. The procedure was completed during the treatment session according to the clinical protocol. Receives: Device: Nd:YAG Laser Application |
| Group 2: Diode Laser | Experimental | Participants assigned to this group received Diode laser application on the affected dentine areas for hypersensitivity treatment. The application was performed in accordance with the specified parameters. Receives: Device: Diode Laser Application |
| Group 3: Dentin Barrier Agent | Experimental | Participants assigned to this group received a topical application of a herbal propolis-based dentin barrier agent onto the hypersensitive tooth surfaces. The agent was applied to seal the dentinal tubules and reduce sensitivity. Receives: Other: Herbal Propolis-Based Dentin Barrier Agent |
| Group 4: Sham Application | Sham comparator | Participants assigned to this group received a sham (placebo) procedure designed to completely simulate the laser or topical application experience without delivering any active laser energy or therapeutic desensitizing agent. This group served as the control to account for the placebo effect. Receives: Other: Sham Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Visual Analog Scale (VAS) Score after Air Stimulus
Pain intensity evaluated using the Visual Analog Scale (VAS), where scores range from 0 (no pain) to 10 (extreme/worst pain). The primary outcome is defined as the change in pain intensity in response to a controlled air blast stimulus from baseline to 6 months.
Measured: Baseline and 6 months
Secondary outcomes (2)
Schiff Cold Air Sensitivity Scale Score
Dentine sensitivity assessed using the Schiff Cold Air Sensitivity Scale, where scores range from 0 (patient does not respond to air stimulus) to 3 (patient responds to air stimulus, experiences pain, and requests discontinuation of stimulus).
Measured: Baseline, immediately post-treatment, 1 week, 1 month, 3 months, and 6 months
Tactile Sensitivity Score
Tactile sensitivity evaluated using a standard dental explorer probe passed across the affected dentine surface to record the presence or absence of discomfort or pain.
Measured: Baseline, immediately post-treatment, 1 week, 1 month, 3 months, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study start15 Dec 2025
- Primary completion10 Jun 2026
- Study completion10 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dentine HypersensitivityStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs 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
- A randomized, parallel-group, evaluator-blinded, sham-controlled clinical trial with four allocation arms. Eligible participants were randomly assigned to one of the four groups in a 1:1:1:1 ratio to receive a single type of intervention (Nd:YAG laser, Diode laser, herbal propolis-based dentin barrier agent, or sham application) and were followed up for a period of 6 months.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yaşar Tolga KAYIM, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07647861
- Sponsor's protocol ID
- 2025000326-2
- Status last verified
- Jun 2026
- First submitted
- 10 Jun 2026
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared publicly to ensure patient confidentiality and compliance with the ethical committee approval, which did not include a provision for public data repository sharing.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Nd:YAG Laser, Diode Laser, Herbal Propolis-Based Dentin Barrier Agent, and Sham Application in the Treatment of Dentine Hypersensitivity: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07647861
- Acronym / sponsor ID
- 2025000326-2
- Conditions
- Dentine Hypersensitivity
- Keywords
- Dentine Hypersensitivity, Nd:YAG Laser, Diode Laser, Propolis, Lasers in Dentistry, Dentin Desensitizing Agents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- 10 Jun 2026 (actual)
- Study completion
- 10 Jun 2026 (actual)
- First posted
- 15 Jun 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.
Dentine hypersensitivity is a common clinical problem. Although Nd:YAG lasers, diode lasers, and topical desensitizing agents are widely utilized, long-term comparative evidence regarding their clinical efficacy remains limited. This prospective, randomized, parallel-arm, evaluator-blind, sham-controlled clinical trial evaluated and compared the 12-month clinical performance of an Nd:YAG laser, a diode laser, a herbal propolis-based dentin barrier agent, and a sham application.
Detailed description
This study was conducted as a prospective, randomized, parallel-arm, evaluator-blinded, sham-controlled clinical trial to evaluate and compare the clinical efficacy of four different treatment modalities for dentine hypersensitivity over a 6-month follow-up period.
A total of 140 patients who met the eligibility criteria were enrolled and randomly allocated into four equal groups (n=35 per group) using a block randomization method with a 1:1:1:1 allocation ratio. The intervention groups were assigned as follows:
Group 1 received Nd:YAG laser application.
Group 2 received Diode laser application.
Group 3 received a topical application of a herbal propolis-based dentin barrier agent.
Group 4 received a sham (placebo) application to simulate the treatment experience without delivering any active laser or therapeutic agent benefits.
Clinical evaluations were performed at baseline, immediately post-treatment, 1 week, 1 month, 3 months, and 6 months. The primary outcome was the change in pain intensity measured by the Visual Analog Scale (VAS) following a controlled air blast stimulus from baseline to 6 months. Secondary outcomes included changes in the Schiff Cold Air Sensitivity Scale, tactile sensitivity scores, patient satisfaction levels, the documentation of any adverse events, and the need for additional treatment during the 6-month period. To ensure objectivity, all clinical assessments and statistical analyses were performed by researchers who were fully blinded to the treatment allocations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- A randomized, parallel-group, evaluator-blinded, sham-controlled clinical trial with four allocation arms. Eligible participants were randomly assigned to one of the four groups in a 1:1:1:1 ratio to receive a single type of intervention (Nd:YAG laser, Diode laser, herbal propolis-based dentin barrier agent, or sham application) and were followed up for a period of 6 months.
| Arm | Type | Receives |
|---|---|---|
| Group 1: Nd:YAG Laser | Experimental | Device: Nd:YAG Laser ApplicationParticipants assigned to this group received Nd:YAG laser application targeted at the hypersensitive teeth to achieve desensitization. The procedure was completed during the treatment session according to the clinical protocol. |
| Group 2: Diode Laser | Experimental | Device: Diode Laser ApplicationParticipants assigned to this group received Diode laser application on the affected dentine areas for hypersensitivity treatment. The application was performed in accordance with the specified parameters. |
| Group 3: Dentin Barrier Agent | Experimental | Other: Herbal Propolis-Based Dentin Barrier AgentParticipants assigned to this group received a topical application of a herbal propolis-based dentin barrier agent onto the hypersensitive tooth surfaces. The agent was applied to seal the dentinal tubules and reduce sensitivity. |
| Group 4: Sham Application | Sham comparator | Other: Sham ApplicationParticipants assigned to this group received a sham (placebo) procedure designed to completely simulate the laser or topical application experience without delivering any active laser energy or therapeutic desensitizing agent. This group served as the control to account for the placebo effect. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients aged between 18 and 65 years.
- Presence of at least two hypersensitive teeth.
- Visual Analog Scale (VAS) score of 4 or higher (VAS >= 4) following stimulus.
- Schiff Cold Air Sensitivity Scale score of 2 or higher (Schiff >= 2).
- Presence of vital teeth in the target area.
Key exclusion criteria (5 listed)
- Pregnancy or lactation.
- Presence of active periodontal disease in the target area.
- Teeth with dental caries, deep restorations, or cracked tooth syndrome.
- Endodontically treated teeth.
- History of allergy or hypersensitivity related to the materials, products, or chemical agents 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 |
|---|---|---|
| Nd:YAG Laser ApplicationNd:YAG laser application performed for the treatment of dentine hypersensitivity. | Device | Group 1: Nd:YAG Laser |
| Diode Laser ApplicationDiode laser application performed for the treatment of dentine hypersensitivity. | Device | Group 2: Diode Laser |
| Herbal Propolis-Based Dentin Barrier AgentTopical application of a herbal propolis-based dentin barrier agent. | Other | Group 3: Dentin Barrier Agent |
| Sham ApplicationPlacebo/sham procedure to simulate treatment without delivering active laser or therapeutic agent benefits | Other | Group 4: Sham Application |
Primary outcome
Change in Visual Analog Scale (VAS) Score after Air Stimulus
Time frame: Baseline and 6 months
Pain intensity evaluated using the Visual Analog Scale (VAS), where scores range from 0 (no pain) to 10 (extreme/worst pain). The primary outcome is defined as the change in pain intensity in response to a controlled air blast stimulus from baseline to 6 months.
2 secondary outcomes
Schiff Cold Air Sensitivity Scale Score
Time frame: Baseline, immediately post-treatment, 1 week, 1 month, 3 months, and 6 months
Tactile Sensitivity Score
Time frame: Baseline, immediately post-treatment, 1 week, 1 month, 3 months, and 6 months
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 15 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared publicly to ensure patient confidentiality and compliance with the ethical committee approval, which did not include a provision for public data repository sharing.
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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 Nd:YAG Laser Application, Diode Laser Application and Herbal Propolis-Based Dentin Barrier Agent in people with Dentine Hypersensitivity, run by Ondokuz Mayıs 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 6 inclusion and 5 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 15 Jun 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 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. Some participants in this study may receive a placebo. 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?
Change in Visual Analog Scale (VAS) Score after Air Stimulus (time frame: Baseline and 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 15 Jun 2026.