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Completed

NCT Number: NCT07647861

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ondokuz Mayıs University, Faculty of Dentistry, Department of Periodontology

Samsun, 55270, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nd:YAG Laser Application

Device

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

Diode laser application

Device

Diode laser application performed for the treatment of dentine hypersensitivity.

Herbal Propolis-Based Dentin Barrier Agent

Other

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

Sham application

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Schiff Cold Air Sensitivity Scale Score

    Time frame: Baseline, immediately post-treatment, 1 week, 1 month, 3 months, and 6 months

    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).

  2. Tactile Sensitivity Score

    Time frame: Baseline, immediately post-treatment, 1 week, 1 month, 3 months, and 6 months

    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.

Sponsors and collaborators

Lead sponsor

Ondokuz Mayıs University

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 15, 2026
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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