Ozone Application Before Fissure Sealants

Not Applicable

Recruiting

• Conditions: Caries,Dental
• Interventions: Device: Ozone; Other: Pits and fissure sealants

• Registration Number: NCT04040920
• Lead Sponsor: IRCCS Burlo Garofolo

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-06-17
• Study First Submitted: 2019-07-30
• Study First Submitted QC: 2019-07-30
• Study First Posted: 2019-08-01
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-16
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 67

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ozone therapy	Ozone	Ozone application before pits and fissure sealants
Ozone therapy	Pits and fissure sealants	Ozone application before pits and fissure sealants
Pits and fissure sealants	Pits and fissure sealants	-

Primary Outcome Measures

Name	Time	Method
Sealants failure	12 months after sealant	Frequency of sealed failure defined as presence of to one or more of these outcomes: Marginal fissure; Sealant fracture; Decay; Marginal pigmentations; Sealant detachment Evaluation of the relative frequency of the different causes of failure

Secondary Outcome Measures

Name	Time	Method
Sealants failure	24 months after sealant	Frequency of sealed failure defined as presence of to one or more of these outcomes: Marginal fissure; Sealant fracture; Decay; Marginal pigmentations; Sealant detachment Evaluation of the relative frequency of the different causes of failure
Secondary decay in failed sealants	24 months after sealant	Frequency of secondary decay in teeth with failed sealants

Trial Locations

Locations (1)

Institute for Maternal and Child Health - IRCCS Burlo Garofolo-; 🇮🇹 Trieste, Italy