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Ozone Therapy in Endodontic Practice, in Vivo Study

NCT ID: NCT00946634

Last Updated: 2011-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2011-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Primary Apical Periodontite

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Ozone Gas

Endodontic protocol preconized by University of Sao Paulo associated to ozone gas 40 mg/L

Group Type EXPERIMENTAL

Ozone

Intervention Type DRUG

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

Regular endodontic protocol preconized by University of Sao Paulo

Group Type ACTIVE_COMPARATOR

Control (no last irrigation)

Intervention Type DRUG

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 Ozone

Endodontic protocol preconized by University of Sao Paulo associated to Aqueous ozone 40mg/L

Group Type EXPERIMENTAL

Aqueous Ozone

Intervention Type DRUG

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

Interventions

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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.

Intervention Type 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.

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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Group 2 Group 1 Group 3

Eligibility Criteria

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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
Minimum Eligible Age

13 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role collaborator

University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Carlos Goes Nogales

Master

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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José L Lage-Marques, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

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Fundação para o Desenvolvimento Científico e Tecnológico da Odontologia of University of Sao Paulo

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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CEP 154/06

Identifier Type: -

Identifier Source: org_study_id