- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Hüsna Selinay S Dağdelen, Doctor of Dental Medicine
- Telefonnummer: +905453051080
- E-mail: selinay428@gmail.com
Undersøgelse Kontakt Backup
- Navn: Ezgi S Sonkaya Akburak, Associate Professor Doctor
- Telefonnummer: +905054974631
- E-mail: sonkayaezgi@yahoo.com
Studiesteder
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sarıçam
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Adana, sarıçam, Tyrkiet (Türkiye), 01250
- Çukurova University
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
Andre navne:
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Eksperimentel: 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.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Dentin Hypersensitivity
Tidsramme: Baseline, immediately after treatment, 1 week, 1 month, and 3 months
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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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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Dentin Hypersensivity
- 18920 (Anden identifikator: Cukurova University Scientific Research Projects Coordination Unit)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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