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
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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-
Samsun
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Samsun, Samsun, Turquie (Türkiye), 55270
- Ondokuz Mayıs University, Faculty of Dentistry, Department of Periodontology
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
|
Expérimental: 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.
|
|
Expérimental: 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.
|
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Comparateur factice: 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.
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Placebo/sham procedure to simulate treatment without delivering active laser or therapeutic agent benefits
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Visual Analog Scale (VAS) Score after Air Stimulus
Délai: 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.
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Baseline and 6 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Schiff Cold Air Sensitivity Scale Score
Délai: 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).
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Baseline, immediately post-treatment, 1 week, 1 month, 3 months, and 6 months
|
|
Tactile Sensitivity Score
Délai: 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.
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Baseline, immediately post-treatment, 1 week, 1 month, 3 months, and 6 months
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2025000326-2
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
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