Skip to main content
OpenTrials
Completed

NCT Number: NCT05853523

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Dentin Sensitivity Stomatognathic Diseases Tooth Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of L'Aquila

L’Aquila, AQ, 67100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Gas ozone

Combination Product

The application of ozone was performed with the HealOzone System X4 (HealOzon, Kavo, Germany). The dentist adapted the silicon cup stricken on the cervical surface of the teeth. The pumping system created the vacuum and the machine applied high dosage of ozone, equal to 32 g/m3, for 30 second.

Diode laser and desensitized gel

Combination Product

The dentist applied desensitized gel (JW-Desensitizing Gel, Heydent Gmbh, Germany) directly on the cervical zone of the teeth. Subsequently the irradiation was performed with Wiser III (Wiser, Doctor Smile, Italy) in the desensitizing assisted mode (preprogramed protocol). The protocol provides consecutively steps (not in contact) with 20 second of interval, 808 wavelength, and power incrementation, from 0,2 till 0,6 W. radiating the entire desensitize surface second using the "black tip" (400 micron). The procedure continued maintaining the tip of the laser on contact with the dentine surface making movement of lawn mowing (brushing technique) for 30 second. Then the surface was rinsed, and the irradiation applied again without the gel.

Primary outcomes

  1. Change from Baseline in Pain on the 10-point Visual Analogue Scale (VAS) immediately after treatment

    Time frame: 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.

  2. Pain on the 10-point Visual Analogue Scale (VAS) at 3 months from treatment

    Time frame: 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.

  3. Pain on the 10-point Visual Analogue Scale (VAS) at 6 months from treatment

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of L'Aquila

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 10, 2023
Registry last updated
May 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.