Clinical Evaluation of the Combined Effect of a Potassium Nitrate Gel and Diode Laser in the Treatment of Dentinal Hypersensitivity: a Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Reduction in Dentinal Hypersensitivity (Shiff Air Index)
Study Overview
Brief Summary
The goal of this randomized clinical trial is to evaluate whether combining a potassium nitrate gel with diode laser therapy is more effective in treating dentinal hypersensitivity compared to using the gel alone. The study involves adult participants with at least two teeth affected by dentinal hypersensitivity. The main questions it aims to answer are:
Does the combined use of potassium nitrate gel and diode laser therapy reduce dentinal hypersensitivity more effectively than gel alone? How does this combined treatment impact sensitivity-related quality of life over time? Researchers will compare the outcomes between the two groups (combined therapy versus gel alone) to determine the effectiveness of the combined treatment.
Participants will:
Undergo assessments of dentinal hypersensitivity using the Shiff Air Index (SAI) and Visual Analog Scale (VAS) at baseline and at follow-ups (1 month, 3 months, and 6 months post-treatment).
Complete a questionnaire to evaluate the impact of dentinal hypersensitivity on daily life at baseline and after 6 months.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adults aged 18 years or older.
- •At least two teeth affected by dentinal hypersensitivity.
- •Good standard of home oral hygiene.
Exclusion Criteria
- •Use of pain relievers.
- •Ongoing orthodontic treatment.
- •Non-vital teeth or teeth with restorative materials.
- •Pregnant or breastfeeding women.
Arms & Interventions
Potassium Nitrate Gel with Diode Laser Therapy
Intervention: Potassium Nitrate Gel and Diode Laser Therapy (Combination Product)
Potassium Nitrate Gel Alone
Intervention: Potassium Nitrate Gel Alone (Drug)
Outcomes
Primary Outcomes
Reduction in Dentinal Hypersensitivity (Shiff Air Index)
Time Frame: Baseline (T0), immediately post-treatment (T1), 1 month (T2), 3 months (T3), and 6 months (T4)
The Shiff Air Index measures sensitivity by applying a standardized air stimulus to the dental surface. Patients report their sensitivity level on a scale from 0 to 3, where 0 indicates no sensitivity and 3 indicates severe sensitivity. The scores are interpreted to assess the degree of dentinal hypersensitivity.
Reduction in Dentinal Hypersensitivity (Visual Analog Scale)
Time Frame: Baseline (T0), immediately post-treatment (T1), 1 month (T2), 3 months (T3), and 6 months (T4).
The Visual Analog Scale (VAS) measures the intensity of pain by asking participants to rate their pain on a 10-point scale, where 0 represents no pain and 10 represents the worst pain imaginable. Participants will receive guidance to mark their pain level on the scale based on their subjective experience, providing a standardized measure of dentinal hypersensitivity.
Secondary Outcomes
- Changes in Quality of Life (Dentine Hypersensitivity Experience Questionnaire)(Baseline (T0) and 6 months (T4))
Investigators
Alessandro Bruni
DDS, Orthod Spec, PhD, Research Fellow
University of Modena and Reggio Emilia