The Desensitizing Treatment Effects of the Laser and Ozone on Dentin Hypersensitivity: In-vivo Comparison

Phase 2

Completed

• Conditions: Dentin Sensitivity
• Interventions: Combination Product: Diode laser and desensitized gel; Combination Product: Gas ozone

• Registration Number: NCT05853523
• Lead Sponsor: University of L'Aquila

Brief Summary

The goal of this split mouth clinical trial is to compare clinical efficacy of diode laser and gas ozone in the treatment of dentine hypersensitivity (DHS) of non-carious-cervical lesion. The main questions it aims to answer are:

* gas ozone affects dentine hypersensitivity?

* diode laser affects dentine hypersensitivity? Participants, affected of DHS , were treated with gas ozone and diode laser.The pain severity was quantified according to the Visual Analogue Scale (VAS) before and after the treatmens.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-27
• Primary Completion: 2022-02-27
• Study Completion: 2022-08-27
• Status Verified: 2023-04
• Study First Submitted: 2023-04-29
• Study First Submitted QC: 2023-05-09
• Last Update Submitted: 2023-05-09
• Study First Posted: 2023-05-10
• Last Update Posted: 2023-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• Stimulated dentine hypersensitivity greater than 6 on visual analogue scale (VAS)
• DHS affected two teeth, not contiguous, of different mouth semiarch.

Exclusion Criteria

• Periodontal surgery in the last 3 month
• Use of desensitizing paste in the last 3 month
• Pregnant or breastfeeding state
• Teeth with caries, reconstructions, pulpits congenital anomalies, fracture, and occlusal interferences.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diode laser group	Diode laser and desensitized gel	Participant received an application of desensitized gel, fluoride and potassium nitrate gel , and a first step of an irradiation with diode laser for 20 second of interval, 808 wavelength, and power incrementation, from 0,2 till 0,6 W, not in contact. Then the second step of irradiation for 30 second in contact with dentine surface, 808 wavelength, and power incrementation, from 0,2 till 0,6 W. Then the surface was rinsed, and the irradiation applied for a third time again without the gel as the second step.
Gas ozone group	Gas ozone	Participant received 32 g/m3 of gas ozone for 30 second.

Primary Outcome Measures

Name	Time	Method
Change from Baseline in Pain on the 10-point Visual Analogue Scale (VAS) immediately after treatment	5 minutes	Two stimuli were adopted to assess the degree of dentine hypersensitivities: evaporative test and tactile test. For the evaporative test, the teeth were trigged by a single operator, experienced, and trained, with a jet of air at a pressure of 45-60 psi at a distance of 2 mm from the buccal surface for 35 s. For the tactile test, the pain was triggered using a probe gently touched the dentine exposed in mesiodistal direction. The patient quantified the pain with the visual analogue scale (VAS) giving a value in the range from 1 (minimum pain) to 10 (maximum pain). The highest value of the pain stimulated by the two methods was registered.
Pain on the 10-point Visual Analogue Scale (VAS) at 6 months from treatment	6 months	Two stimuli were adopted to assess the degree of dentine hypersensitivities: evaporative test and tactile test. For the evaporative test, the teeth were trigged by a single operator, experienced, and trained, with a jet of air at a pressure of 45-60 psi at a distance of 2 mm from the buccal surface for 35 s. For the tactile test, the pain was triggered using a probe gently touched the dentine exposed in mesiodistal direction. The patient quantified the pain with the visual analogue scale (VAS) giving a value in the range from 1 (minimum pain) to 10 (maximum pain). The highest value of the pain stimulated by the two methods was registered.
Pain on the 10-point Visual Analogue Scale (VAS) at 3 months from treatment	3 months	Two stimuli were adopted to assess the degree of dentine hypersensitivities: evaporative test and tactile test. For the evaporative test, the teeth were trigged by a single operator, experienced, and trained, with a jet of air at a pressure of 45-60 psi at a distance of 2 mm from the buccal surface for 35 s. For the tactile test, the pain was triggered using a probe gently touched the dentine exposed in mesiodistal direction. The patient quantified the pain with the visual analogue scale (VAS) giving a value in the range from 1 (minimum pain) to 10 (maximum pain). The highest value of the pain stimulated by the two methods was registered.

Trial Locations

Locations (1)

University of L'Aquila; 🇮🇹 L'Aquila, AQ, Italy