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Ozone Application Before Fissure Sealants

I

IRCCS Burlo Garofolo

Status

Enrolling

Conditions

Caries,Dental

Treatments

Other: Pits and fissure sealants
Device: Ozone

Study type

Interventional

Funder types

Other

Identifiers

NCT04040920
RC 02/2019

Details and patient eligibility

About

Decay is a multifactorial infective degenerative disease of hard dental tissues, caused by Streptococcus mutans and Lactobacillus forming the bacterial biofilm of teeth surfaces. Decays generally evolve in fissures and pits of secondary molars. Pits and fissure sealants prevent decays if performed in two years from eruption. Ozone has bactericidal effect and remineralizing capacity on enamel.

The aim of this study is to assess the effectiveness of ozone application before sealants in increasing their duration in time.

Enrollment

67 estimated patients

Sex

All

Ages

6 to 16 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • first or second secondary molars to be sealed
  • possibility to isolate with rubber dam both the teeth involved
  • no clear signs of pigmentations
  • good general health

Exclusion criteria

  • latex allergy
  • epilepsy or other severe neurological pathologies
  • psychiatric disease
  • excessive sensibility to electrical current
  • severe asthma
  • enamel disorders, such as amelogenesis imperfect, white spots, fluorosis or Molar Incisors Hypomineralization

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

67 participants in 2 patient groups

Ozone therapy
Experimental group
Description:
Ozone application before pits and fissure sealants
Treatment:
Device: Ozone
Other: Pits and fissure sealants
Pits and fissure sealants
Active Comparator group
Treatment:
Other: Pits and fissure sealants

Trial contacts and locations

1

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Central trial contact

Chiara Navarra, DDS,MSc,PhD; Milena Cadenaro, DDS,MSc,PhD

Data sourced from clinicaltrials.gov

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