Back to resultsOzone Application Before Fissure Sealants
Primary Purpose
Caries,Dental
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Ozone
Pits and fissure sealants
Sponsored by
About this trial
This is an interventional treatment trial for Caries,Dental focused on measuring Ozone, Pits and fissures sealants, Prevention
Eligibility 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
Sites / Locations
- Institute for Maternal and Child Health - IRCCS Burlo Garofolo-Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Ozone therapy
Pits and fissure sealants
Arm Description
Ozone application before pits and fissure sealants
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
Secondary decay in failed sealants
Frequency of secondary decay in teeth with failed sealants
Secondary decay in failed sealants
Frequency of secondary decay in teeth with failed sealants
Secondary decay in failed sealants
Frequency of secondary decay in teeth with failed sealants
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04040920
Brief Title
Ozone Application Before Fissure Sealants
Official Title
The Effect of Ozone Application Before Fissure Sealants: a Split Mouth Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 17, 2019 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IRCCS Burlo Garofolo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caries,Dental
Keywords
Ozone, Pits and fissures sealants, Prevention
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Splith mouth design
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
67 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ozone therapy
Arm Type
Experimental
Arm Description
Ozone application before pits and fissure sealants
Arm Title
Pits and fissure sealants
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Ozone
Intervention Description
One minute of pretreatment with ozone by using the OzoneDTA device
Intervention Type
Other
Intervention Name(s)
Pits and fissure sealants
Intervention Description
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'';
Primary Outcome Measure Information:
Title
Sealants failure
Description
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
Time Frame
12 months after sealant
Secondary Outcome Measure Information:
Title
Sealants failure
Description
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
Time Frame
6 months after sealant
Title
Sealants failure
Description
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
Time Frame
24 months after sealant
Title
Secondary decay in failed sealants
Description
Frequency of secondary decay in teeth with failed sealants
Time Frame
6 months after sealant
Title
Secondary decay in failed sealants
Description
Frequency of secondary decay in teeth with failed sealants
Time Frame
12 months after sealant
Title
Secondary decay in failed sealants
Description
Frequency of secondary decay in teeth with failed sealants
Time Frame
24 months after sealant
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Milena Cadenaro, DDS,MSc,PhD
Phone
+390403785358
Email
milena.cadenaro@burlo.trieste.it
First Name & Middle Initial & Last Name or Official Title & Degree
Chiara Navarra, DDS,MSc,PhD
Phone
+390403785358
Email
chiara.navarra@burlo.trieste.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Milena Cadenaro, DDS,MSc,PhD
Organizational Affiliation
IRCCS Burlo Garofolo
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Maddalena Chermetz, DDS,MSc
Organizational Affiliation
IRCCS Burlo Garofolo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute for Maternal and Child Health - IRCCS Burlo Garofolo-
City
Trieste
ZIP/Postal Code
34137
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Milena Cadenaro
Email
milena.cadenaro@burlo.trieste.it
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data collected during the study will be available from the Study Director on reasonable request after evaluation of a protocol approved by an Ethical Committee
IPD Sharing Time Frame
After publication of data on peer reviewed journals
IPD Sharing Access Criteria
Data collected during the study will be available from the Study Director on reasonable request after evaluation of a protocol approved by an Ethical Committee
Learn more about this trial
Ozone Application Before Fissure Sealants
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