Nano-hydroxyapatite and Ozone - Effect on Approximal Initial Caries

Influence of Nano-hydroxyapatite and Ozone 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.

Study Overview

• Status: Completed
• Conditions: Caries,Dental
• Intervention / Treatment: Other: ApaCare & Repair

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Phase 2; Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 30 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: domestic nanohydroxyapatite gel ApaCare & Repair; 6-months treatment, caries lesions were assessed on bitewing radiographs at baseline, after 1 year and after 2 years	Other: ApaCare & Repair; Initial cariuos lesions were treated.; Other Names: OzonyTron
Experimental: in-office ozone therapy OzonyTron; 6-months treatment, caries lesions were assessed on bitewing radiographs at baseline, after 1 year and after 2 years	Other: ApaCare & Repair; Initial cariuos lesions were treated.; Other Names: OzonyTron
Experimental: 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	Other: ApaCare & Repair; Initial cariuos lesions were treated.; Other Names: OzonyTron

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Remineralizing effect	Caries lesions were assessed on bitewing radiographs	baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Remineralizing effect - follow-up	Caries lesions were assessed on bitewing radiographs	after 1 year and after 2 years

Collaborators and Investigators

• Sponsor: Pomeranian Medical University Szczecin

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2012
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: October 21, 2019
• First Submitted That Met QC Criteria: October 30, 2019
• First Posted (Actual): October 31, 2019

Study Record Updates

• Last Update Posted (Actual): October 31, 2019
• Last Update Submitted That Met QC Criteria: October 30, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: KB-0012/102/11

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No