- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07648147
Evaluation of Different Non-Invasive Methods in the Treatment of Dentin Hypersensitivity Associated With Non-Carious Cervical Lesions: A Split-Mouth Clinical Study (NCCL-DH)
EVALUATION OF DIFFERENT NON-INVASIVE METHODS IN THE TREATMENT OF DENTIN HYPERSENSITIVITY ASSOCIATED WITH NON-CARIOUS CERVICAL LESIONS: A SPLIT-MOUTH CLINICAL STUDY
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
This split-mouth clinical study was designed to compare the clinical effectiveness of two different non-invasive approaches used in the treatment of dentin hypersensitivity associated with non-carious cervical lesions (NCCLs). Dentin hypersensitivity is a common clinical condition characterized by a short, sharp pain arising from exposed dentin in response to thermal, evaporative, tactile, osmotic, or chemical stimuli. Non-carious cervical lesions play a significant role in the development of dentin hypersensitivity by exposing dentin surfaces to the oral environment.
In this study, the effectiveness of D Blue diode laser application and ProSylc bioactive glass powder application in reducing dentin hypersensitivity will be evaluated. The split-mouth study design will allow each participant to serve as their own control, thereby minimizing interindividual variability. Eligible teeth will be allocated to different treatment groups according to the study protocol, and all interventions will be performed following standardized clinical procedures.
The level of dentin hypersensitivity will be assessed before treatment and at predetermined follow-up intervals using standardized clinical evaluation methods. Based on the collected data, the effects of both treatment modalities on dentin hypersensitivity will be compared, and changes over time will be analyzed. In addition, the clinical applicability and patient tolerance of the interventions will be evaluated.
The findings of this study are expected to contribute to the existing literature regarding the effectiveness of non-invasive treatment methods for dentin hypersensitivity associated with non-carious cervical lesions and to provide evidence-based guidance for clinicians in selecting appropriate treatment approaches.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Hüsna Selinay S Dağdelen, Doctor of Dental Medicine
- Numéro de téléphone: +905453051080
- E-mail: selinay428@gmail.com
Sauvegarde des contacts de l'étude
- Nom: Ezgi S Sonkaya Akburak, Associate Professor Doctor
- Numéro de téléphone: +905054974631
- E-mail: sonkayaezgi@yahoo.com
Lieux d'étude
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sarıçam
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Adana, sarıçam, Turquie (Türkiye), 01250
- Cukurova University
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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:
- Individuals aged between 18 and 65 years. Systemically healthy individuals. Individuals with dentin hypersensitivity. Presence of two permanent teeth with similar severity of dentin hypersensitivity in the same participant.
Participants who agree to participate in the study and sign the informed consent form
Exclusion Criteria:
- Presence of active caries in the study teeth. Presence of cervical restoration in the study teeth. Presence of pulpal pathology. History of desensitizing treatment within the last 3 months. Pregnancy. Presence of systemic disease. Use of analgesics within the last 48 hours.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: D Blue Diode Laser Group
Teeth assigned to this group will receive D Blue diode laser application for the management of dentin hypersensitivity associated with non-carious cervical lesions.
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D Blue diode laser application for the treatment of dentin hypersensitivity associated with non-carious cervical lesions.
Autres noms:
|
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Expérimental: ProSylc Bioactive Glass Group
Teeth assigned to this group will receive ProSylc bioactive glass powder application for the management of dentin hypersensitivity associated with non-carious cervical lesions.
|
ProSylc bioactive glass powder application for the treatment of dentin hypersensitivity associated with non-carious cervical lesions.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Dentin Hypersensitivity
Délai: Baseline, immediately after treatment, 1 week, 1 month, and 3 months
|
Dentin hypersensitivity will be assessed using a Visual Analog Scale (VAS) following standardized air stimulus application.
The change in VAS scores from baseline to follow-up visits will be evaluated.
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Baseline, immediately after treatment, 1 week, 1 month, and 3 months
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
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
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- Dentin Hypersensivity
- 18920 (Autre identifiant: Cukurova University Scientific Research Projects Coordination Unit)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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