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Completed

NCT Number: NCT04147091

Nano-hydroxyapatite and Ozone - Effect on Approximal Initial Caries

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.

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Key information

Conditions

Caries,Dental Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

20 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ApaCare & Repair

Other

Initial cariuos lesions were treated.

Other names: OzonyTron

Primary outcomes

  1. Remineralizing effect

    Time frame: baseline

    Caries lesions were assessed on bitewing radiographs

Secondary outcomes

  1. Remineralizing effect - follow-up

    Time frame: after 1 year and after 2 years

    Caries lesions were assessed on bitewing radiographs

Sponsors and collaborators

Lead sponsor

Pomeranian Medical University Szczecin

Other

Registry information

Official study title

Influence of Nano-hydroxyapatite and Ozone on Approximal Initial Caries

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Oct 31, 2019
Registry last updated
Oct 31, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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