Ozone Therapy in Endodontic Practice, in Vivo Study
This study has been completed.
Sponsor:
University of Sao Paulo
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Carlos Goes Nogales, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT00946634
First received: July 23, 2009
Last updated: October 2, 2011
Last verified: October 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Primary Apical Periodontite |
Drug: Ozone Drug: Control (no last irrigation) Drug: Aqueous Ozone |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Phase 4 - Ozone Therapy in Endodontic Practice, in Vivo Study |
Resource links provided by NLM:
Further study details as provided by University of Sao Paulo:
Primary Outcome Measures:
- Acceleration in repair by healing of apical periodontite [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 60 |
| Study Start Date: | January 2009 |
| Study Completion Date: | March 2011 |
| Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Ozone Gas
Endodontic protocol preconized by University of Sao Paulo associated to ozone gas 40 mg/L
|
Drug: Ozone
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.
Other Name: Group 2
|
|
Active Comparator: Control
Regular endodontic protocol preconized by University of Sao Paulo
|
Drug: Control (no last irrigation)
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.
Other Name: Group 1
|
|
Experimental: Aqueous Ozone
Endodontic protocol preconized by University of Sao Paulo associated to Aqueous ozone 40mg/L
|
Drug: Aqueous Ozone
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
Other Name: Group 3
|
Eligibility| Ages Eligible for Study: | 13 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Healthy patients
- Radiographic evidence of apical periodontite
- No previous root canal treatment
Exclusion Criteria:
- Unhealthy patients
- Regular response to sensibility test
- Previous root canal treatment
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00946634
Locations
| Brazil | |
| Fundação para o Desenvolvimento Científico e Tecnológico da Odontologia of University of Sao Paulo | |
| Sao Paulo, SP, Brazil, 05508-000 | |
Sponsors and Collaborators
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
| Principal Investigator: | José L Lage-Marques, Professor | University of Sao Paulo |
More Information
No publications provided
| Responsible Party: | Carlos Goes Nogales, Master, University of Sao Paulo |
| ClinicalTrials.gov Identifier: | NCT00946634 History of Changes |
| Other Study ID Numbers: | CEP 154/06 |
| Study First Received: | July 23, 2009 |
| Last Updated: | October 2, 2011 |
| Health Authority: | Brazil: Ethics Committee |
ClinicalTrials.gov processed this record on June 17, 2013