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Efficacy of Lasers, Propolis-Based Agent, and Sham for Dentine Hypersensitivity

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07647861
Enrollment
140
Registered
2026-06-15
Start date
2025-12-15
Completion date
2026-06-10
Last updated
2026-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dentine Hypersensitivity

Keywords

Dentine Hypersensitivity, Nd:YAG Laser, Diode Laser, Propolis, Lasers in Dentistry, Dentin Desensitizing Agents

Brief 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. 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.

Interventions

DEVICENd:YAG Laser Application

Nd:YAG laser application performed for the treatment of dentine hypersensitivity.

Diode laser application performed for the treatment of dentine hypersensitivity.

OTHERHerbal Propolis-Based Dentin Barrier Agent

Topical application of a herbal propolis-based dentin barrier agent.

Placebo/sham procedure to simulate treatment without delivering active laser or therapeutic agent benefits

Sponsors

Ondokuz Mayıs University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Visual Analog Scale (VAS) Score after Air StimulusBaseline and 6 monthsPain 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.

Secondary

MeasureTime frameDescription
Schiff Cold Air Sensitivity Scale ScoreBaseline, immediately post-treatment, 1 week, 1 month, 3 months, and 6 monthsDentine 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).
Tactile Sensitivity ScoreBaseline, immediately post-treatment, 1 week, 1 month, 3 months, and 6 monthsTactile sensitivity evaluated using a standard dental explorer probe passed across the affected dentine surface to record the presence or absence of discomfort or pain.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 16, 2026