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

10. juni 2026 opdateret af: Yaşar Tolga KAYIM, Ondokuz Mayıs University

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

140

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Tyrkiet (Türkiye)
    • Samsun
      • Samsun, Samsun, Tyrkiet (Türkiye), 55270
        • Ondokuz Mayıs University, Faculty of Dentistry, Department of Periodontology

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Group 1: Nd:YAG Laser
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.
Enhed: Nd:YAG Laser Application
Nd:YAG laser application performed for the treatment of dentine hypersensitivity.
Eksperimentel: Group 2: Diode Laser
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.
Enhed: Diode Laser Application
Diode laser application performed for the treatment of dentine hypersensitivity.
Eksperimentel: Group 3: Dentin Barrier Agent
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.
Andet: Herbal Propolis-Based Dentin Barrier Agent
Topical application of a herbal propolis-based dentin barrier agent.
Sham-komparator: Group 4: Sham Application
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.
Andet: Sham Application
Placebo/sham procedure to simulate treatment without delivering active laser or therapeutic agent benefits

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Visual Analog Scale (VAS) Score after Air Stimulus
Tidsramme: 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.
Baseline and 6 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Schiff Cold Air Sensitivity Scale Score
Tidsramme: 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).
Baseline, immediately post-treatment, 1 week, 1 month, 3 months, and 6 months
Tactile Sensitivity Score
Tidsramme: 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.
Baseline, immediately post-treatment, 1 week, 1 month, 3 months, and 6 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Ondokuz Mayıs University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

15. december 2025

Primær færdiggørelse (Faktiske)

10. juni 2026

Studieafslutning (Faktiske)

10. juni 2026

Datoer for studieregistrering

Først indsendt

10. juni 2026

Først indsendt, der opfyldte QC-kriterier

10. juni 2026

Først opslået (Faktiske)

15. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2025000326-2

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

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