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

10 juni 2026 uppdaterad av: 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.

Studieöversikt

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

140

Fas

  • Inte tillämpbar

Kontakter och platser

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Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Nd:YAG laser application performed for the treatment of dentine hypersensitivity.
Experimentell: 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.
Diode laser application performed for the treatment of dentine hypersensitivity.
Experimentell: 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.
Topical application of a herbal propolis-based dentin barrier agent.
Sham Comparator: 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.
Placebo/sham procedure to simulate treatment without delivering active laser or therapeutic agent benefits

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Visual Analog Scale (VAS) Score after Air Stimulus
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Schiff Cold Air Sensitivity Scale Score
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

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Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

15 december 2025

Primärt slutförande (Faktisk)

10 juni 2026

Avslutad studie (Faktisk)

10 juni 2026

Studieregistreringsdatum

Först inskickad

10 juni 2026

Först inskickad som uppfyllde QC-kriterierna

10 juni 2026

Första postat (Faktisk)

15 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

15 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

10 juni 2026

Senast verifierad

1 juni 2026

Mer information

Termer relaterade till denna studie

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

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.

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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