NCT04040920

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started Jun 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress91%
Jun 2019Dec 2026

Study Start

First participant enrolled

June 17, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 30, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 1, 2019

Completed
7.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

May 16, 2025

Status Verified

May 1, 2025

Enrollment Period

7.5 years

First QC Date

July 30, 2019

Last Update Submit

May 13, 2025

Conditions

Caries,Dental

Keywords

OzonePits and fissures sealantsPrevention

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Sealants failure

    6 months after sealant

  • Sealants failure

    24 months after sealant

  • Secondary decay in failed sealants

    6 months after sealant

  • Secondary decay in failed sealants

    12 months after sealant

  • Secondary decay in failed sealants

    24 months after sealant

Study Arms (2)

Ozone therapy

EXPERIMENTAL

Ozone application before pits and fissure sealants

Device: OzoneOther: Pits and fissure sealants

Pits and fissure sealants

ACTIVE COMPARATOR
Other: Pits and fissure sealants

Interventions

OzoneDEVICE

One minute of pretreatment with ozone by using the OzoneDTA device

Ozone therapy
Pits and fissure sealantsOTHER

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'';

Ozone therapyPits and fissure sealants

Eligibility Criteria

Age6 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute for Maternal and Child Health - IRCCS Burlo Garofolo-

Trieste, Trieste, 34137, Italy

RECRUITING

MeSH Terms

Conditions

Dental Caries

Interventions

Pit and Fissure Sealants

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental MaterialsBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Milena Cadenaro, DDS,MSc,PhD

    IRCCS Burlo Garofolo

    STUDY CHAIR

  • Maddalena Chermetz, DDS,MSc

    IRCCS Burlo Garofolo

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Milena Cadenaro, DDS,MSc,PhD

CONTACT

+390403785358milena.cadenaro@burlo.trieste.it

Chiara Navarra, DDS,MSc,PhD

CONTACT

+390403785358chiara.navarra@burlo.trieste.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Splith mouth design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2019

First Posted

August 1, 2019

Study Start

June 17, 2019

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

May 16, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
After publication of data on peer reviewed journals
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

Locations

IT(1)