Nano-hydroxyapatite and Ozone - Effect on Approximal Initial Caries

Phase 2

Completed

• Conditions: Caries,Dental
• Interventions: Other: ApaCare & Repair

• Registration Number: NCT04147091
• Lead Sponsor: Pomeranian Medical University Szczecin

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2019-10
• Study First Submitted: 2019-10-21
• Study First Submitted QC: 2019-10-30
• Last Update Submitted: 2019-10-30
• Study First Posted: 2019-10-31
• Last Update Posted: 2019-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
domestic nanohydroxyapatite gel ApaCare & Repair	ApaCare & Repair	6-months treatment, caries lesions were assessed on bitewing radiographs at baseline, after 1 year and after 2 years
both remineralizing gel and ozone therapy	ApaCare & Repair	6-months treatment, caries lesions were assessed on bitewing radiographs at baseline, after 1 year and after 2 years
in-office ozone therapy OzonyTron	ApaCare & Repair	6-months treatment, caries lesions were assessed on bitewing radiographs at baseline, after 1 year and after 2 years

Primary Outcome Measures

Name	Time	Method
Remineralizing effect	baseline	Caries lesions were assessed on bitewing radiographs

Secondary Outcome Measures

Name	Time	Method
Remineralizing effect - follow-up	after 1 year and after 2 years	Caries lesions were assessed on bitewing radiographs