Actively Recruiting
The Effect of Ozone Application Before Fissure Sealants: a Split Mouth Randomized Controlled Trial
Led by IRCCS Burlo Garofolo · Updated on 2025-05-16
67
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Dental decay is a complex disease affecting the hard tissues of teeth, mainly caused by bacteria like Streptococcus mutans and Lactobacillus forming biofilm on tooth surfaces. This decay usually occurs in the grooves and pits of secondary molars. Sealants placed in these pits and fissures can prevent decay if applied within two years after the tooth erupts. Ozone therapy, which has bactericidal and enamel remineralizing properties, is being studied to see if applying it before sealants can help sealants last longer. The study compares the use of ozone applied with the OzoneDTA device for one minute before placing pits and fissure sealants. The sealant procedure includes cleaning the tooth surface, etching with orthophosphoric acid, drying, applying the sealant material, and polymerizing it. Participants receive sealants with and without ozone pretreatment in a randomized, split-mouth design to evaluate the effect of ozone on sealant longevity. During the study, researchers will monitor sealant failures at 6, 12, and 24 months after placement, as well as any secondary decay in failed sealants. Participants will have their first or second secondary molars sealed and isolated using a rubber dam. The study includes assessments of sealant condition and dental health over two years to measure the durability and effectiveness of the treatments under study.
CONDITIONS
Brief Title
Ozone Application Before Fissure Sealants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- First or second secondary molars to be sealed
- Ability to isolate both teeth with a rubber dam
- No clear signs of pigmentation on the teeth
- Good general health
You will not qualify if you...
- Allergy to latex
- Epilepsy or other severe neurological diseases
- Psychiatric disease
- Excessive sensitivity to electrical current
- Severe asthma
- Enamel disorders such as amelogenesis imperfecta, white spots, fluorosis, or Molar Incisors Hypomineralization
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single treatment visit
Participants receive ozone application before the placement of pits and fissure sealants on designated teeth.
1 visit (in-person)
Duration - Up to 24 months after sealant application
Participants are monitored for sealant failure and secondary decay after treatment.
Follow-up visits at 6, 12, and 24 months
Trial Site Locations
Total: 1 location
1
Institute for Maternal and Child Health - IRCCS Burlo Garofolo-
Trieste, Trieste, Italy, 34137
Actively Recruiting
Research Team
M
Milena Cadenaro, DDS,MSc,PhD
C
Chiara Navarra, DDS,MSc,PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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