Dentine Hypersensitivity Treated With Laser and Fluoride.

Not Applicable

• Conditions: Sensitive Dentin
• Interventions: Device: Laser and Fluoride; Other: Fluoride

• Registration Number: NCT06202495
• Lead Sponsor: University of Pavia

Brief Summary

The aim of the present report is to evaluate the amino fluoride gel with or without application of diode laser on pain due to dentine hypersensitivity.

NRS (numerical rating scale) index will be used to evaluate the pain suffered by each patient after cold air blow stimulus.

After treatment application, the follow-up timing planned for each patient will be at 1 week, 1 month, 3 months and 6 months

Detailed Description

The aim of the present report is to evaluate the amino fluoride gel with or without application of diode laser on pain due to dentine hypersensitivity.

The study is designed with a split mouth design. NRS (numerical rating scale) index will be used to evaluate the pain suffered by each patient. The pain response will be stimulated by thermal urge (cold air blow). Teeth will be divided in two groups. The treatment group, treated with 980nm diode laser and amino fluoride gel; the control group, treated only with amino fluoride gel.

The follow-up timing planned for each patient will be at 1 week, 1 month, 3 months and 6 months. In these follow-up sessions a revaluation of the pain response is performed using the NRS index.

Study Timeline

• Study First Submitted: 2024-01-01
• Study First Submitted QC: 2024-01-01
• Study First Posted: 2024-01-11
• Study Start: 2024-01-15
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-18
• Last Update Posted: 2024-02-20
• Primary Completion: 2024-07-05
• Study Completion: 2024-07-10

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

• Teeth in good periodontal health
• Good oral hygiene
• Dentine hypersensitivity: NRS (Numerical Rating Scale) ≥ 3

Exclusion Criteria

• Teeth local disease or fractures in treatment area
• Irreversible teeth necrosis or pulpitis
• Definitive restorations or veneers
• Recent use of painkillers or anti-inflammatory drugs,
• Treatment for dentine Hypersensitivity less than 6 months before the study start
• Therapies contraindication

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laser and Fluoride	Laser and Fluoride	The treatment group will be treated with amino-fluoride gel (Elmex Dental Gel, Colgate-Palmolive company, New York, 300 Park Ave, United States) in association 980nm diode laser (doctor smile wiser by Lambda s.p.a. Via dell'Impresa, 1, 36040 Brendola VI, Italy) 1.5 W, pulsed mode 2 mm from tooth surface. For treatment will be used 400 μm diameter and 5 mm long tips of for 4 minutes
Fluoride	Fluoride	The control group will be treated with amino-fluoride gel (Elmex Dental Gel, Colgate-Palmolive company, New York, 300 Park Ave, United States) for 4 minutes.

Primary Outcome Measures

Name	Time	Method
NRS (numerical rating scale)	Before treatment and 1 week, 1 month, 3 months, 6 months after treatment	The dentine hypersensitivity will be evaluated with the Numerical Rating Scale ( NRS ), where 0 meant pain absence and 10 a unbearable pain (Hjermstad MJ, Fayers PM, Haugen DF, Caraceni A, Hanks GW, Loge JH, et al. Studies comparing Numerical Rating Scales, Verbal Rating Scales, and Visual Analogue Scales for assessment of pain intensity in adults: a systematic literature review. J Pain Symptom Manage. 2011;41(6):1073-93.)

Trial Locations

Locations (1)

A.O. Mater Domini, U.O. Odontoiatria, University of Catanzaro "Magna Græcia".; 🇮🇹 Catanzaro, Italy