Dentin Hypersensitivity - Varnish or Laser?

NCT ID: NCT06539286

Last Updated: 2024-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-02

Study Completion Date

2024-12-14

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Dentin hypersensitivity is a common condition described as a short and sharp pain caused by thermal, evaporative, tactile, osmotic, or chemical stimuli to exposed dentin that cannot be related to another defect or dental pathology. The variety of treatment options and products on the market might seem overwhelming. This study aims to show that laser treatments are efficient in reducing pain scores compared to a desensitizing agent (Gluma). 80 patients with at least two hypersensitive teeth will be enrolled in this study. Patients will be divided randomly into four groups (control group (Gluma), laser group 1 (2.94 µm wavelength), laser group 2 (1064 nm wavelength), laser group 3 (970 nm wavelength)). Visual Analog Scale will be measured before treatment, right after treatment, one week after treatment, one month after treatment, three months after treatment. Mixed Anova's and descriptive analysis will be used for statistical evaluation.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

A total of 80 patients meeting the inclusion criteria will be included in this randomized clinical study. Participants will be randomly divided into four groups. Pain scores will be measured before treatment, right after treatment, 1 month after treatment and 3 months after treatment using the Visual Analog Scala (VAS). Patients will not know which treatment will be performed before nor will the patients from the laser groups know the wavelengths. Pain scores at check-up meetings will be collected by another doctor other than the one who will perform all laser treatments.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dentin Hypersensitivity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Patients will not know which laser will be used in the treatment group.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control

Desensitizing Agent Gluma

Group Type ACTIVE_COMPARATOR

Laser Irradiation

Intervention Type DEVICE

three different laser wavelengths will be used

1. Laser Group

Er:YAG laser

Group Type ACTIVE_COMPARATOR

Laser Irradiation

Intervention Type DEVICE

three different laser wavelengths will be used

2. Laser Group

Nd:YAG laser

Group Type ACTIVE_COMPARATOR

Laser Irradiation

Intervention Type DEVICE

three different laser wavelengths will be used

3. Laser Group

970 nm diode laser

Group Type ACTIVE_COMPARATOR

Laser Irradiation

Intervention Type DEVICE

three different laser wavelengths will be used

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Laser Irradiation

three different laser wavelengths will be used

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Desensitizing Agent Gluma

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* all genders
* 18-70 years
* good general health
* at least two hypersensitive teeth in either jaw
* initial VAS-score \>3

Exclusion Criteria

* Active carious lesions, insufficient restorations, enamel cracks, reversible pulpitis
* Active periodontal disease, periodontal surgery (in the last 6 months)
* Bleaching procedure in the last 3 months
* Analgetic use in the last 72 hours
* Pregnant/lactating women
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sigmund Freud PrivatUniversitat

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DH

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.