Ozone Application Before Fissure Sealants

Sponsor

IRCCS Burlo Garofolo (Other)

Overall Status

Recruiting

CT.gov ID

NCT04040920

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Caries,Dental	Device: Ozone Other: Pits and fissure sealants	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

67 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Splith mouth designSplith mouth design

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 1, 2021

Anticipated Primary Completion Date :

Sep 30, 2022

Anticipated Study Completion Date :

Sep 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ozone therapy Ozone application before pits and fissure sealants	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'';
Active Comparator: Pits and fissure sealants	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'';

Arm

Intervention/Treatment

Experimental: Ozone therapy

Ozone application before pits and fissure sealants

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'';

Active Comparator: Pits and fissure sealants

Other: Pits and fissure sealants

Outcome Measures

Primary Outcome Measures

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

Sealants failure [6 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
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 [6 months after sealant]
Frequency of secondary decay in teeth with failed sealants
Secondary decay in failed sealants [12 months after sealant]
Frequency of secondary decay in teeth with failed sealants
Secondary decay in failed sealants [24 months after sealant]
Frequency of secondary decay in teeth with failed sealants

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 16 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institute for Maternal and Child Health - IRCCS Burlo Garofolo-	Trieste		Italy	34137

Sponsors and Collaborators

IRCCS Burlo Garofolo

Investigators

Study Chair: Milena Cadenaro, DDS,MSc,PhD, IRCCS Burlo Garofolo
Principal Investigator: Maddalena Chermetz, DDS,MSc, IRCCS Burlo Garofolo

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

IRCCS Burlo Garofolo

ClinicalTrials.gov Identifier:

NCT04040920

Other Study ID Numbers:

RC 02/2019

First Posted:

Aug 1, 2019

Last Update Posted:

Jan 6, 2022

Last Verified:

Dec 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by IRCCS Burlo Garofolo

Ozone

Pits and fissures sealants

Prevention

Additional relevant MeSH terms:

Dental Caries

Study Results

No Results Posted as of Jan 6, 2022