NCT06539286

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 1, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 6, 2024

Completed
27 days until next milestone

Study Start

First participant enrolled

September 2, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 14, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 14, 2024

Completed
Last Updated

August 6, 2024

Status Verified

August 1, 2024

Enrollment Period

1 month

First QC Date

August 1, 2024

Last Update Submit

August 1, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Visual Analog Scale changes

    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

Study Arms (4)

Control

ACTIVE COMPARATOR

Desensitizing Agent Gluma

Device: Laser Irradiation

1. Laser Group

ACTIVE COMPARATOR

Er:YAG laser

Device: Laser Irradiation

2. Laser Group

ACTIVE COMPARATOR

Nd:YAG laser

Device: Laser Irradiation

3. Laser Group

ACTIVE COMPARATOR

970 nm diode laser

Device: Laser Irradiation

Interventions

three different laser wavelengths will be used

Also known as: Desensitizing Agent Gluma
1. Laser Group2. Laser Group3. Laser GroupControl

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dentin Sensitivity

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapy

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Patients will not know which laser will be used in the treatment group.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2024

First Posted

August 6, 2024

Study Start

September 2, 2024

Primary Completion

October 14, 2024

Study Completion

December 14, 2024

Last Updated

August 6, 2024

Record last verified: 2024-08