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

Sponsor
University of L'Aquila (Other)
Overall Status
Completed
CT.gov ID
NCT05853523
Collaborator
(none)
44
1
2
17.9
2.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Combination Product: Gas ozone
  • Combination Product: Diode laser and desensitized gel
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
44 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Split Mouth: all patients involved received both treatments randomly assigned to either the right or left halves of the dentition.Split Mouth: all patients involved received both treatments randomly assigned to either the right or left halves of the dentition.
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Desensitizing Treatment Effects of the Laser and Ozone on Dentin Hypersensitivity: In-vivo Comparison
Actual Study Start Date :
Feb 27, 2021
Actual Primary Completion Date :
Feb 27, 2022
Actual Study Completion Date :
Aug 27, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

  3. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of L'Aquila L'Aquila AQ Italy 67100

Sponsors and Collaborators

  • University of L'Aquila

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Maurizio D'Amario, Dott. Maurizio D'Amario, University of L'Aquila
ClinicalTrials.gov Identifier:
NCT05853523
Other Study ID Numbers:
  • CONS 01_21
First Posted:
May 10, 2023
Last Update Posted:
May 10, 2023
Last Verified:
Apr 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 10, 2023