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

NCT ID: NCT05853523

Last Updated: 2023-05-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-27
• Study Completion Date: 2022-08-27

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.

Conditions

Dentin Sensitivity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Gas ozone group

Participant received 32 g/m3 of gas ozone for 30 second.

Group Type: EXPERIMENTAL

Gas ozone

Intervention Type: 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 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.

Group Type: EXPERIMENTAL

Diode laser and desensitized gel

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: COMBINATION_PRODUCT

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of L'Aquila

OTHER

Sponsor Role: lead

Responsible Party

Maurizio D'Amario

Dott. Maurizio D'Amario

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maurizio D'Amario

Role: PRINCIPAL_INVESTIGATOR

University of L'Aquila

Locations

University of L'Aquila

L’Aquila, AQ, Italy

Countries

Italy

References

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.

Reference Type: BACKGROUND

PMID: 9402502 (View on PubMed)

Other Identifiers

CONS 01_21

Identifier Type: -

Identifier Source: org_study_id