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NCT04147091 Clinical Trial

Nano-hydroxyapatite and Ozone - Effect on Approximal Initial Caries

Caries,Dental Clinical Trial

Official title:
Influence of Nano-hydroxyapatite and Ozone on Approximal Initial Caries

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04147091
Other study ID # KB-0012/102/11
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received
Last updated
Start date February 2012
Est. completion date December 2016

Study information
Verified date October 2019
Source Pomeranian Medical University Szczecin
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 92
Est. completion date December 2016
Est. primary completion date December 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 30 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• ApaCare & Repair
Initial cariuos lesions were treated.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Pomeranian Medical University Szczecin

Outcome
Type Measure Description Time frame Safety issue
Primary Remineralizing effect Caries lesions were assessed on bitewing radiographs baseline
Secondary Remineralizing effect - follow-up Caries lesions were assessed on bitewing radiographs after 1 year and after 2 years
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