Dentin Hypersensitivity - Varnish or Laser?

August 1, 2024 updated by: Sigmund Freud PrivatUniversitat

Dentin Hypersensitivity - Varnish or Laser? A Randomized Clinical Study Comparing Three Wavelengths (2940 nm, 1064 nm and 970 nm) and the Desensitizer Gluma

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control
Desensitizing Agent Gluma
Device: Laser Irradiation
three different laser wavelengths will be used
Other Names:
  • Desensitizing Agent Gluma
Active Comparator: 1. Laser Group
Er:YAG laser
Device: Laser Irradiation
three different laser wavelengths will be used
Other Names:
  • Desensitizing Agent Gluma
Active Comparator: 2. Laser Group
Nd:YAG laser
Device: Laser Irradiation
three different laser wavelengths will be used
Other Names:
  • Desensitizing Agent Gluma
Active Comparator: 3. Laser Group
970 nm diode laser
Device: Laser Irradiation
three different laser wavelengths will be used
Other Names:
  • Desensitizing Agent Gluma

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale changes
Time Frame: three months
Patients will rate pain score with VAS. Pain scores will be evaluated before treatment, right after treatment, one week later, one month later and three months later
three months

Collaborators and Investigators

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

Sponsor

Sigmund Freud PrivatUniversitat

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)

September 2, 2024

Primary Completion (Estimated)

October 14, 2024

Study Completion (Estimated)

December 14, 2024

Study Registration Dates

First Submitted

August 1, 2024

First Submitted That Met QC Criteria

August 1, 2024

First Posted (Actual)

August 6, 2024

Study Record Updates

Last Update Posted (Actual)

August 6, 2024

Last Update Submitted That Met QC Criteria

August 1, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DH

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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