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

NCT07647861 | Completed

• 1 other identifier: 2025000326-2
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Dentine Hypersensitivity

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Schiff Cold Air Sensitivity Scale Score

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

• Tactile Sensitivity Score

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

Study Arms (4)

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.

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.

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.

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.

Other: Sham Application

Interventions

Nd:YAG Laser Application DEVICE

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

Group 1: Nd:YAG Laser

Diode Laser Application DEVICE

Diode laser application performed for the treatment of dentine hypersensitivity.

Group 2: Diode Laser

Herbal Propolis-Based Dentin Barrier Agent OTHER

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

Group 3: Dentin Barrier Agent

Sham Application OTHER

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

Group 4: Sham Application

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Study Sites (1)

Ondokuz Mayıs University, Faculty of Dentistry, Department of Periodontology

Samsun, Samsun, 55270, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dentin Sensitivity

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: 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.

Study Record Dates

• First Submitted: June 10, 2026
• First Posted: June 15, 2026
• Study Start: December 15, 2025
• Primary Completion: June 10, 2026
• Study Completion: June 10, 2026
• Last Updated: June 15, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)