Ozone Therapy in Endodontic Practice, in Vivo Study

NCT00946634 | Completed Phase 2 DMC

• 1 other identifier: CEP 154/06
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Primary Apical Periodontite

Outcome Measures

Primary Outcomes (1)

• Acceleration in repair by healing of apical periodontite

  3 months

Study Arms (3)

Ozone Gas

EXPERIMENTAL

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

Drug: Ozone

Control

ACTIVE COMPARATOR

Regular endodontic protocol preconized by University of Sao Paulo

Drug: Control (no last irrigation)

Aqueous Ozone

EXPERIMENTAL

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

Drug: Aqueous Ozone

Interventions

Ozone 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.

Also known as: Group 2

Ozone Gas

Control (no last irrigation) 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.

Also known as: Group 1

Control

Aqueous Ozone 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

Also known as: Group 3

Aqueous Ozone

Eligibility Criteria

• Age: 13 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Healthy patients
• Radiographic evidence of apical periodontite
• No previous root canal treatment

You may not qualify if:

• Unhealthy patients
• Regular response to sensibility test
• Previous root canal treatment

Sponsors & Collaborators

• University of Sao Paulo: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

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

São Paulo, São Paulo, 05508-000, Brazil

Location

MeSH Terms

Interventions

Ozone

Intervention Hierarchy (Ancestors)

Oxygen; Gases; Inorganic Chemicals

Study Officials

• José L Lage-Marques, Professor

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master

Study Record Dates

• First Submitted: July 23, 2009
• First Posted: July 27, 2009
• Study Start: January 1, 2009
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2011
• Last Updated: October 4, 2011

Record last verified: 2011-10

Locations

BR (1)