Primary Apical PeriodontitePhase 2NCT00946634
Ozone Therapy in Endodontic Practice, in Vivo Study
A Phase 2 study testing Ozone and Aqueous Ozone in people with Primary Apical Periodontite, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The ozone therapy has been coming up as a new therapeutic modality. Medicine has been practicing since XIX century and counted great results. It is indicated for the treatment of 260 different pathologies. Read more about this study
- Who is it for?
- Ages 13 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Apical Periodontite
- What is being tested?
- Ozone and Aqueous Ozone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2009to Mar 2011
- Phase
- Phase 2
- 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 13 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Healthy patients
- Radiographic evidence of apical periodontite
- No previous root canal treatment
Who cannot join
- Unhealthy patients
- Regular response to sensibility test
- Previous root canal treatment
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Fundação para o Desenvolvimento Científico e Tecnológico da Odontologia of University of Sao Paulo
São Paulo, São Paulo, 05508-000
About this study
Official title: Phase 4 - Ozone Therapy in Endodontic Practice, in Vivo Study
The ozone therapy has been coming up as a new therapeutic modality. Medicine has been practicing since XIX century and counted great results. It is indicated for the treatment of 260 different pathologies. The researches in Dentistry has showed promising results, indicating a wide spread action in whole dental specialties. The great oxidative power of ozone provides a great antimicrobial effect and it increases the adenosine triphosphate (ATP) synthesis that can be considered as a general improvement of the cell metabolism, which can potentize the repair process. Thus, these facts justify the present study which will assess the increase of speed of apical periodontite repair.
- Conditions
- Primary Apical Periodontite
- Being tested
- Ozone, Control (no last irrigation), Aqueous Ozone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OzoneDrug
Also called Group 2
Regular endodontic protocol preconized by University of Sao Paulo. Root canal irrigation with 1% Sodium Hypochlorite associated to Endo PTC (10mL), final irrigation with EDTA-T 17% remaining for 3 minutes. After a last foaming with ozone gas (Philozon, Santa Catarina, Brazil) at 40mg/L concentration.
Control (no last irrigation)Drug
Also called Group 1
Regular endodontic protocol preconized by University of Sao Paulo. Root canal irrigation with 1% Sodium Hypochlorite associated to Endo PTC (10mL), final irrigation with EDTA-T 17% remaining for 3 minutes.
Aqueous OzoneDrug
Also called Group 3
Regular endodontic protocol preconized by University of Sao Paulo. Root canal irrigation with 1% Sodium Hypochlorite associated to Endo PTC (10mL), final irrigation with EDTA-T 17% remaining for 3 minutes. A last irrigation with 10mL of ozonated water at 40mg/mL concentration
| Study group | Role | What they receive |
|---|---|---|
| Ozone Gas | Experimental | Endodontic protocol preconized by University of Sao Paulo associated to ozone gas 40 mg/L Receives: Drug: Ozone |
| Control | Active comparator | Regular endodontic protocol preconized by University of Sao Paulo Receives: Drug: Control (no last irrigation) |
| Aqueous Ozone | Experimental | Endodontic protocol preconized by University of Sao Paulo associated to Aqueous ozone 40mg/L Receives: Drug: Aqueous Ozone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceleration in repair by healing of apical periodontite
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2009 (estimated)
- Study startJan 2009
- Primary completionMar 2009
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Apical PeriodontiteStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Carlos Goes Nogales, University of Sao Paulo
- Investigators
- José L Lage-Marques, Professor, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00946634
- Sponsor's protocol ID
- CEP 154/06
- Status last verified
- Oct 2011
- First submitted
- 23 Jul 2009
- Last updated
- 4 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 - Ozone Therapy in Endodontic Practice, in Vivo Study
- ClinicalTrials.gov ID
- NCT00946634
- Acronym / sponsor ID
- CEP 154/06
- Conditions
- Primary Apical Periodontite
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Jan 2009
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 27 Jul 2009 (estimated)
- 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.
The ozone therapy has been coming up as a new therapeutic modality. Medicine has been practicing since XIX century and counted great results. It is indicated for the treatment of 260 different pathologies. The researches in Dentistry has showed promising results, indicating a wide spread action in whole dental specialties. The great oxidative power of ozone provides a great antimicrobial effect and it increases the adenosine triphosphate (ATP) synthesis that can be considered as a general improvement of the cell metabolism, which can potentize the repair process. Thus, these facts justify the present study which will assess the increase of speed of apical periodontite repair.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ozone Gas | Experimental | Drug: OzoneEndodontic protocol preconized by University of Sao Paulo associated to ozone gas 40 mg/L |
| Control | Active comparator | Drug: Control (no last irrigation)Regular endodontic protocol preconized by University of Sao Paulo |
| Aqueous Ozone | Experimental | Drug: Aqueous OzoneEndodontic protocol preconized by University of Sao Paulo associated to Aqueous ozone 40mg/L |
Who may qualify
- Ages
- 13 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Healthy patients
- Radiographic evidence of apical periodontite
- No previous root canal treatment
Key exclusion criteria (3 listed)
- Unhealthy patients
- Regular response to sensibility test
- Previous root canal treatment
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 |
|---|---|---|
| OzoneAlso: Group 2Regular endodontic protocol preconized by University of Sao Paulo. Root canal irrigation with 1% Sodium Hypochlorite associated to Endo PTC (10mL), final irrigation with EDTA-T 17% remaining for 3 minutes. After a last foaming with ozone gas (Philozon, Santa Catarina, Brazil) at 40mg/L concentration. | Drug | Ozone Gas |
| Control (no last irrigation)Also: Group 1Regular endodontic protocol preconized by University of Sao Paulo. Root canal irrigation with 1% Sodium Hypochlorite associated to Endo PTC (10mL), final irrigation with EDTA-T 17% remaining for 3 minutes. | Drug | Control |
| Aqueous OzoneAlso: Group 3Regular endodontic protocol preconized by University of Sao Paulo. Root canal irrigation with 1% Sodium Hypochlorite associated to Endo PTC (10mL), final irrigation with EDTA-T 17% remaining for 3 minutes. A last irrigation with 10mL of ozonated water at 40mg/mL concentration | Drug | Aqueous Ozone |
Primary outcome
Acceleration in repair by healing of apical periodontite
Time frame: 3 months
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 4 Oct 2011.
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.
José L Lage-Marques, Professor principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ozone and Aqueous Ozone in people with Primary Apical Periodontite, run by University of Sao Paulo at 1 site in Brazil.
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 3 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 4 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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 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.
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?
Acceleration in repair by healing of apical periodontite (time frame: 3 months). 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 4 Oct 2011.