Nano-hydroxyapatite and Ozone - Effect on Approximal Initial Caries
Influence of Nano-hydroxyapatite and Ozone on Approximal Initial Caries
1 other identifier
interventional
92
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Feb 2012
Longer than P75 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedFirst Submitted
Initial submission to the registry
October 21, 2019
CompletedFirst Posted
Study publicly available on registry
October 31, 2019
CompletedOctober 31, 2019
October 1, 2019
4.8 years
October 21, 2019
October 30, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Remineralizing effect
Caries lesions were assessed on bitewing radiographs
baseline
Secondary Outcomes (1)
Remineralizing effect - follow-up
after 1 year and after 2 years
Study Arms (3)
domestic nanohydroxyapatite gel ApaCare & Repair
EXPERIMENTAL6-months treatment, caries lesions were assessed on bitewing radiographs at baseline, after 1 year and after 2 years
in-office ozone therapy OzonyTron
EXPERIMENTAL6-months treatment, caries lesions were assessed on bitewing radiographs at baseline, after 1 year and after 2 years
both remineralizing gel and ozone therapy
EXPERIMENTAL6-months treatment, caries lesions were assessed on bitewing radiographs at baseline, after 1 year and after 2 years
Interventions
Initial cariuos lesions were treated.
Eligibility Criteria
You may qualify if:
- initial approximal enamel lesions on premolar and molar teeth
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. DDS, PhD
Study Record Dates
First Submitted
October 21, 2019
First Posted
October 31, 2019
Study Start
February 1, 2012
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
October 31, 2019
Record last verified: 2019-10