Clinical trial

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

Name

CONS 01_21

Description

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.

Trial arms

Trial start

2021-02-27

Estimated PCD

2022-02-27

Trial end

2022-08-27

Status

Completed

Phase

Early phase I

Treatment

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.

Arms:

Gas ozone group

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.

Arms:

Diode laser group

Size

Primary endpoint

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

5 minutes

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

3 months

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

6 months

Eligibility criteria

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Split Mouth: all patients involved received both treatments randomly assigned to either the right or left halves of the dentition.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 44, 'type': 'ACTUAL'}}

Updated at

2023-05-10

1 organization

Organization

University of L'Aquila