Ozone Application Before Fissure Sealants

Caries,Dental Clinical Trial

Official title:

The Effect of Ozone Application Before Fissure Sealants: a Split Mouth Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04040920
• Other study ID #: RC 02/2019
• Status: Recruiting
• Phase: N/A
• Start date: June 17, 2019
• Est. completion date: September 30, 2023

Study information

• Verified date: March 2023
• Source: IRCCS Burlo Garofolo
• Contact: Milena Cadenaro, DDS,MSc,PhD
• Phone: +390403785358
• Email: milena.cadenaro[@]burlo.trieste.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 67
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Caries,Dental
• Dental Caries

Intervention

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'';

Locations

Country	Name	City	State
Italy	Institute for Maternal and Child Health - IRCCS Burlo Garofolo-	Trieste

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Burlo Garofolo

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sealants failure	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	12 months after sealant
Secondary	Sealants failure	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	6 months after sealant
Secondary	Sealants failure	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	24 months after sealant
Secondary	Secondary decay in failed sealants	Frequency of secondary decay in teeth with failed sealants	6 months after sealant
Secondary	Secondary decay in failed sealants	Frequency of secondary decay in teeth with failed sealants	12 months after sealant
Secondary	Secondary decay in failed sealants	Frequency of secondary decay in teeth with failed sealants	24 months after sealant