search
Back to results

Nano-hydroxyapatite and Ozone - Effect on Approximal Initial Caries

Primary Purpose

Caries,Dental

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
ApaCare & Repair
Sponsored by
Pomeranian Medical University Szczecin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Caries,Dental

Eligibility Criteria

20 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

-initial approximal enamel lesions on premolar and molar teeth

Exclusion Criteria:

  • distal surface of the last tooth in arch, overlapping teeth
  • fillings on approximal surfaces of teeth of interest
  • ongoing orthodontic therapy with braces or other appliances

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    domestic nanohydroxyapatite gel ApaCare & Repair

    in-office ozone therapy OzonyTron

    both remineralizing gel and ozone therapy

    Arm Description

    6-months treatment, caries lesions were assessed on bitewing radiographs at baseline, after 1 year and after 2 years

    6-months treatment, caries lesions were assessed on bitewing radiographs at baseline, after 1 year and after 2 years

    6-months treatment, caries lesions were assessed on bitewing radiographs at baseline, after 1 year and after 2 years

    Outcomes

    Primary Outcome Measures

    Remineralizing effect
    Caries lesions were assessed on bitewing radiographs

    Secondary Outcome Measures

    Remineralizing effect - follow-up
    Caries lesions were assessed on bitewing radiographs

    Full Information

    First Posted
    October 21, 2019
    Last Updated
    October 30, 2019
    Sponsor
    Pomeranian Medical University Szczecin
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04147091
    Brief Title
    Nano-hydroxyapatite and Ozone - Effect on Approximal Initial Caries
    Official Title
    Influence of Nano-hydroxyapatite and Ozone on Approximal Initial Caries
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2012 (Actual)
    Primary Completion Date
    December 2016 (Actual)
    Study Completion Date
    December 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Pomeranian Medical University Szczecin

    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
    Objectives: to assess the efficiency of three methods of enamel remineralization on initial approximal caries: 1. a nano-hydroxyapatite gel, 2. gaseous ozone therapy 3. combination of a nano-hydroxyapatite gel and ozone. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Caries,Dental

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    92 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    domestic nanohydroxyapatite gel ApaCare & Repair
    Arm Type
    Experimental
    Arm Description
    6-months treatment, caries lesions were assessed on bitewing radiographs at baseline, after 1 year and after 2 years
    Arm Title
    in-office ozone therapy OzonyTron
    Arm Type
    Experimental
    Arm Description
    6-months treatment, caries lesions were assessed on bitewing radiographs at baseline, after 1 year and after 2 years
    Arm Title
    both remineralizing gel and ozone therapy
    Arm Type
    Experimental
    Arm Description
    6-months treatment, caries lesions were assessed on bitewing radiographs at baseline, after 1 year and after 2 years
    Intervention Type
    Other
    Intervention Name(s)
    ApaCare & Repair
    Other Intervention Name(s)
    OzonyTron
    Intervention Description
    Initial cariuos lesions were treated.
    Primary Outcome Measure Information:
    Title
    Remineralizing effect
    Description
    Caries lesions were assessed on bitewing radiographs
    Time Frame
    baseline
    Secondary Outcome Measure Information:
    Title
    Remineralizing effect - follow-up
    Description
    Caries lesions were assessed on bitewing radiographs
    Time Frame
    after 1 year and after 2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    30 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: -initial approximal enamel lesions on premolar and molar teeth Exclusion Criteria: distal surface of the last tooth in arch, overlapping teeth fillings on approximal surfaces of teeth of interest ongoing orthodontic therapy with braces or other appliances

    12. IPD Sharing Statement

    Learn more about this trial

    Nano-hydroxyapatite and Ozone - Effect on Approximal Initial Caries

    We'll reach out to this number within 24 hrs