Ozone Therapy in Endodontic Practice, in Vivo Study

Primary Apical Periodontite Clinical Trial

Official title:

Phase 4 - Ozone Therapy in Endodontic Practice, in Vivo Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00946634
• Other study ID #: CEP 154/06
• Status: Completed
• Phase: Phase 2
• First received: July 23, 2009
• Last updated: October 2, 2011
• Start date: January 2009
• Est. completion date: March 2011

Study information

• Verified date: October 2011
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2011
• Est. primary completion date: March 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 13 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Primary Apical Periodontite

Intervention

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.
• 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.
• 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

Locations

Country	Name	City	State
Brazil	Fundação para o Desenvolvimento Científico e Tecnológico da Odontologia of University of Sao Paulo	Sao Paulo	SP

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceleration in repair by healing of apical periodontite		3 months	Yes