Dentine Hypersensitivity Treated With Laser and Fluoride.

February 18, 2024 updated by: Andrea Scribante, University of Pavia

Dentine Hypersensitivity Treated With Diode Laser and Amino Fluoride: A Randomized Clinical Trial

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

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

43

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Catanzaro, Italy
        • A.O. Mater Domini, U.O. Odontoiatria, University of Catanzaro "Magna Græcia".

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Device: Laser and Fluoride
topic application of 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
Active Comparator: 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.
Other: Fluoride
topic application of amino-fluoride gel (Elmex Dental Gel, Colgate-Palmolive company, New York, 300 Park Ave, United States)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NRS (numerical rating scale)
Time Frame: 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.)
Before treatment and 1 week, 1 month, 3 months, 6 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pavia

Investigators

  • Principal Investigator: Andrea Scribante, DDS PhD MSc, Unit of Dental Hygiene - Section of Dentistry - Dep of Clin Surg Diagn Ped Sci - University of Pavia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2024

Primary Completion (Estimated)

July 5, 2024

Study Completion (Estimated)

July 10, 2024

Study Registration Dates

First Submitted

January 1, 2024

First Submitted That Met QC Criteria

January 1, 2024

First Posted (Actual)

January 11, 2024

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 18, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-FLUORIDELASER

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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