Caries,DentalPhase 2/3NCT04147091
Nano-hydroxyapatite and Ozone - Effect on Approximal Initial Caries
A Phase 2/3 study testing ApaCare & Repair in people with Caries,Dental, run by Pomeranian Medical University Szczecin.
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. Read more about this study
- Who is it for?
- Ages 20 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Caries,Dental
- What is being tested?
- ApaCare & Repair
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- No sites listed yet
- Study dates
- Feb 2012to Dec 2016
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- -initial approximal enamel lesions on premolar and molar teeth
Who cannot join
- 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
About this study
Official title: 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.
- Conditions
- Caries,Dental
- Being tested
- ApaCare & Repair
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApaCare & RepairOther
Also called OzonyTron
Initial cariuos lesions were treated.
| Study group | Role | What they receive |
|---|---|---|
| domestic nanohydroxyapatite gel ApaCare & Repair | Experimental | 6-months treatment, caries lesions were assessed on bitewing radiographs at baseline, after 1 year and after 2 years Receives: Other: ApaCare & Repair |
| in-office ozone therapy OzonyTron | Experimental | 6-months treatment, caries lesions were assessed on bitewing radiographs at baseline, after 1 year and after 2 years Receives: Other: ApaCare & Repair |
| both remineralizing gel and ozone therapy | Experimental | 6-months treatment, caries lesions were assessed on bitewing radiographs at baseline, after 1 year and after 2 years Receives: Other: ApaCare & Repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remineralizing effect
Caries lesions were assessed on bitewing radiographs
Measured: baseline
Secondary outcomes (1)
Remineralizing effect - follow-up
Caries lesions were assessed on bitewing radiographs
Measured: after 1 year and after 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2019
- Study startFeb 2012
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caries,DentalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pomeranian Medical University Szczecin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katarzyna Grocholewicz, Pomeranian Medical University Szczecin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04147091
- Sponsor's protocol ID
- KB-0012/102/11
- Status last verified
- Oct 2019
- First submitted
- 21 Oct 2019
- Last updated
- 31 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Nano-hydroxyapatite and Ozone on Approximal Initial Caries
- ClinicalTrials.gov ID
- NCT04147091
- Acronym / sponsor ID
- KB-0012/102/11
- Conditions
- Caries,Dental
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Pomeranian Medical University SzczecinUniversity, hospital or other
- Study start
- Feb 2012 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 31 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| domestic nanohydroxyapatite gel ApaCare & Repair | Experimental | Other: ApaCare & Repair6-months treatment, caries lesions were assessed on bitewing radiographs at baseline, after 1 year and after 2 years |
| in-office ozone therapy OzonyTron | Experimental | Other: ApaCare & Repair6-months treatment, caries lesions were assessed on bitewing radiographs at baseline, after 1 year and after 2 years |
| both remineralizing gel and ozone therapy | Experimental | Other: ApaCare & Repair6-months treatment, caries lesions were assessed on bitewing radiographs at baseline, after 1 year and after 2 years |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- -initial approximal enamel lesions on premolar and molar teeth
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ApaCare & RepairAlso: OzonyTronInitial cariuos lesions were treated. | Other | both remineralizing gel and ozone therapy, domestic nanohydroxyapatite gel ApaCare & Repair, in-office ozone therapy OzonyTron |
Primary outcome
Remineralizing effect
Time frame: baseline
Caries lesions were assessed on bitewing radiographs
1 secondary outcome
Remineralizing effect - follow-up
Time frame: after 1 year and after 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing ApaCare & Repair in people with Caries,Dental, run by Pomeranian Medical University Szczecin.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Remineralizing effect (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2019.