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.

Study Overview

• Status: Completed
• Conditions: Dentin Sensitivity
• Intervention / Treatment: Combination product: Gas ozone; Combination product: Diode laser and desensitized gel

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Phase 2

Contacts and Locations

Study Locations

• Italy
  • AQ
    • L'Aquila, AQ, Italy, 67100
      • University of L'Aquila

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Gas ozone group; Participant received 32 g/m3 of gas ozone for 30 second.	Combination product: Gas ozone; 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.
Experimental: Diode laser group; 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.	Combination product: Diode laser and desensitized gel; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Pain on the 10-point Visual Analogue Scale (VAS) immediately after treatment	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.	5 minutes
Pain on the 10-point Visual Analogue Scale (VAS) at 3 months from treatment	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 months
Pain on the 10-point Visual Analogue Scale (VAS) at 6 months from treatment	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.	6 months

Collaborators and Investigators

• Sponsor: University of L'Aquila
• Investigators: Principal Investigator: Maurizio D'Amario, University of L'Aquila

Publications and helpful links

General Publications

• Holland GR, Narhi MN, Addy M, Gangarosa L, Orchardson R. Guidelines for the design and conduct of clinical trials on dentine hypersensitivity. J Clin Periodontol. 1997 Nov;24(11):808-13. doi: 10.1111/j.1600-051x.1997.tb01194.x.

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2021
• Primary Completion (Actual): February 27, 2022
• Study Completion (Actual): August 27, 2022

Study Registration Dates

• First Submitted: April 29, 2023
• First Submitted That Met QC Criteria: May 9, 2023
• First Posted (Actual): May 10, 2023

Study Record Updates

• Last Update Posted (Actual): May 10, 2023
• Last Update Submitted That Met QC Criteria: May 9, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Stomatognathic Diseases; Tooth Diseases; Hypersensitivity; Dentin Sensitivity
• Other Study ID Numbers: CONS 01_21

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No