- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hüsna Selinay S Dağdelen, Doctor of Dental Medicine
- Phone Number: +905453051080
- Email: selinay428@gmail.com
Study Contact Backup
- Name: Ezgi S Sonkaya Akburak, Associate Professor Doctor
- Phone Number: +905054974631
- Email: sonkayaezgi@yahoo.com
Study Locations
-
-
sarıçam
-
Adana, sarıçam, Turkey (Türkiye), 01250
- Çukurova University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
D Blue diode laser application for the treatment of dentin hypersensitivity associated with non-carious cervical lesions.
Other Names:
|
|
Experimental: 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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Dentin Hypersensitivity
Time Frame: 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.
|
Baseline, immediately after treatment, 1 week, 1 month, and 3 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Dentin Hypersensivity
- 18920 (Other Identifier: Cukurova University Scientific Research Projects Coordination Unit)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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