Nano-hydroxyapatite and Ozone - Effect on Approximal Initial Caries
NCT ID: NCT04147091
Last Updated: 2019-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2/PHASE3
92 participants
INTERVENTIONAL
2012-02-29
2016-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Materials and Methods: Patients (n=92, age 20-30y) with initial approximal enamel lesions on premolar and molar teeth (n=546) randomly allocated to three groups subjected to a 6-months treatment: Group I: domestic nano-hydroxyapatite remineralizing gel, group II: in-office ozone therapy, group III: both remineralizing gel and ozone therapy. Caries lesions assessed on bitewing radiographs at baseline, after 1 year and after 2 years.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
domestic nanohydroxyapatite gel ApaCare & Repair
6-months treatment, caries lesions were assessed on bitewing radiographs at baseline, after 1 year and after 2 years
ApaCare & Repair
Initial cariuos lesions were treated.
in-office ozone therapy OzonyTron
6-months treatment, caries lesions were assessed on bitewing radiographs at baseline, after 1 year and after 2 years
ApaCare & Repair
Initial cariuos lesions were treated.
both remineralizing gel and ozone therapy
6-months treatment, caries lesions were assessed on bitewing radiographs at baseline, after 1 year and after 2 years
ApaCare & Repair
Initial cariuos lesions were treated.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ApaCare & Repair
Initial cariuos lesions were treated.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* fillings on approximal surfaces of teeth of interest
* ongoing orthodontic therapy with braces or other appliances
20 Years
30 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Pomeranian Medical University Szczecin
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Katarzyna Grocholewicz
Prof. DDS, PhD
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
KB-0012/102/11
Identifier Type: -
Identifier Source: org_study_id