NCT06202495

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 1, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 11, 2024

Completed
4 days until next milestone

Study Start

First participant enrolled

January 15, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 5, 2024

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2024

Completed
Last Updated

February 20, 2024

Status Verified

February 1, 2024

Enrollment Period

6 months

First QC Date

January 1, 2024

Last Update Submit

February 18, 2024

Conditions

Sensitive Dentin

Keywords

Dentine hypersensitivityfluoridelaser

Outcome Measures

Primary Outcomes (1)

  • NRS (numerical rating scale)

    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

Study Arms (2)

Laser and Fluoride

EXPERIMENTAL

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

Fluoride

ACTIVE COMPARATOR

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

Interventions

Laser and FluorideDEVICE

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

Laser and Fluoride
FluorideOTHER

topic application of amino-fluoride gel (Elmex Dental Gel, Colgate-Palmolive company, New York, 300 Park Ave, United States)

Fluoride

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Catanzaro, Italy

Location

MeSH Terms

Conditions

Dentin Sensitivity

Interventions

LasersFluorides

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Optical DevicesEquipment and SuppliesRadiation Equipment and SuppliesAnionsIonsElectrolytesInorganic ChemicalsHydrofluoric AcidFluorine Compounds

Study Officials

  • Andrea Scribante, DDS PhD MSc

    Unit of Dental Hygiene - Section of Dentistry - Dep of Clin Surg Diagn Ped Sci - University of Pavia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 1, 2024

First Posted

January 11, 2024

Study Start

January 15, 2024

Primary Completion

July 5, 2024

Study Completion

July 10, 2024

Last Updated

February 20, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)