Using ozone to enhance the effectiveness of dental sealants
The Effect of Ozone Application Before Fissure Sealants: a Split Mouth Randomized Controlled Trial
This study is testing if using ozone on teeth before putting on sealants can help keep those sealants working longer to prevent cavities.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 67 (estimated) |
| Ages | 6 Years to 16 Years |
| Sex | All |
| Sponsor | IRCCS Burlo Garofolo Academic / other |
| Locations | 1 site (Trieste, Trieste) |
| Trial ID | NCT04040920 on ClinicalTrials.gov |
What this trial studies
This study investigates the application of ozone on first or second secondary molars before the placement of pits and fissure sealants. The goal is to determine if ozone, known for its bactericidal properties and ability to remineralize enamel, can prolong the effectiveness of sealants in preventing dental caries. Participants will undergo a procedure where ozone is applied to their teeth, followed by the sealing process. The study aims to assess the long-term benefits of this combined approach in dental care.
Who should consider this trial
Good fit: Ideal candidates are children or adolescents with first or second secondary molars that are suitable for sealing and in good general health.
Not a fit: Patients with latex allergies, severe neurological conditions, or specific enamel disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of dental caries in children and adolescents by enhancing the longevity of sealants.
How similar studies have performed: While the use of ozone in dental treatments has been explored, this specific approach of combining ozone application with sealants is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Trieste, Trieste
- Institute for Maternal and Child Health - IRCCS Burlo Garofolo- — Trieste, Trieste, Italy (Recruiting)
Study contacts
- Principal investigator: Maddalena Chermetz, DDS,MSc — IRCCS Burlo Garofolo
- Study coordinator: Milena Cadenaro, DDS,MSc,PhD
- Email: milena.cadenaro@burlo.trieste.it
- Phone: +390403785358
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.