Ozone Therapy in Endodontic Practice, in Vivo Study

This study has been completed.
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014