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)

June 10, 2026 updated by: Husna Selinay, Cukurova University

EVALUATION OF DIFFERENT NON-INVASIVE METHODS IN THE TREATMENT OF DENTIN HYPERSENSITIVITY ASSOCIATED WITH NON-CARIOUS CERVICAL LESIONS: A SPLIT-MOUTH CLINICAL STUDY

The aim of this split-mouth clinical study is to compare the effectiveness of D Blue diode laser application and ProSylc bioactive glass powder application in reducing dentin hypersensitivity in patients with non-carious cervical lesions (NCCLs). Different treatment modalities will be applied within the same participant, and changes in dentin hypersensitivity will be evaluated following treatment. The primary outcome measure will be the reduction in dentin hypersensitivity after the interventions. The findings of this study are expected to contribute to the identification of effective non-invasive treatment approaches for the management of dentin hypersensitivity associated with non-carious cervical lesions.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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

  • Turkey (Türkiye)
    • sarıçam
      • Adana, sarıçam, Turkey (Türkiye), 01250
        • Çukurova University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Device: D Blue Diode Laser
D Blue diode laser application for the treatment of dentin hypersensitivity associated with non-carious cervical lesions.
Other Names:
  • Diode Laser
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.
Device: ProSylc Bioactive Glass Powder
ProSylc bioactive glass powder application for the treatment of dentin hypersensitivity associated with non-carious cervical lesions.
Other Names:
  • Bioactive Glass Powder

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cukurova University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 20, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 20, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 20, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 10, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 15, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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