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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nd:YAG Laser Application | Device | Nd:YAG laser application performed for the treatment of dentine hypersensitivity. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline, immediately post-treatment, 1 week, 1 month, 3 months, and 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ondokuz Mayıs University, Faculty of Dentistry, Department of Periodontology | Samsun | Samsun | 55270 | Turkey (Türkiye) |
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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| ID | Term |
|---|---|
| D003807 | Dentin Sensitivity |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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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.
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| Diode Laser Application | Device | Diode laser application performed for the treatment of dentine hypersensitivity. |
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| Herbal Propolis-Based Dentin Barrier Agent | Other | Topical application of a herbal propolis-based dentin barrier agent. |
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| Sham Application | Other | Placebo/sham procedure to simulate treatment without delivering active laser or therapeutic agent benefits |
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| 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. | Baseline, immediately post-treatment, 1 week, 1 month, 3 months, and 6 months |