Ozone Application Before Fissure Sealants
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ozone, Pits and fissure sealants.
- Who it may be relevant to
- Registry conditions: Caries,Dental. Basic parameters: 6 years — 16 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Effect of Ozone Application Before Fissure Sealants: a Split Mouth Randomized Controlled Trial
Overview
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.
Interventions
- Device Ozone
One minute of pretreatment with ozone by using the OzoneDTA device - Other Pits and fissure sealants
cleansing of the occlusal surfaces with a nylon brush and polishing toothpaste; surface etching with 36% orthophosphoric acid for 30'', surface cleaning and drying for 30 '', application of the sealing material, polymerization for 60'';
Primary outcome measures
- Sealants failure [Time frame: 12 months after sealant]
Secondary outcome measures (5)
- Sealants failure [Time frame: 6 months after sealant]
- Sealants failure [Time frame: 24 months after sealant]
- Secondary decay in failed sealants [Time frame: 6 months after sealant]
- Secondary decay in failed sealants [Time frame: 12 months after sealant]
- Secondary decay in failed sealants [Time frame: 24 months after sealant]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Italy · 1 center
- Institute for Maternal and Child Health - IRCCS Burlo Garofolo- — Trieste
Identifiers
NCT: NCT04040920 · RC 02/2019