Dentin Hypersensitivity - Varnish or Laser?
1 other identifier
interventional
80
0 countries
N/A
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2024
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 1, 2024
CompletedFirst Posted
Study publicly available on registry
August 6, 2024
CompletedStudy Start
First participant enrolled
September 2, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 14, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 14, 2024
CompletedAugust 6, 2024
August 1, 2024
1 month
August 1, 2024
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 COMPARATORDesensitizing Agent Gluma
1. Laser Group
ACTIVE COMPARATOREr:YAG laser
2. Laser Group
ACTIVE COMPARATORNd:YAG laser
3. Laser Group
ACTIVE COMPARATOR970 nm diode laser
Interventions
three different laser wavelengths will be used
Eligibility Criteria
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
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
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