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Comparison of the success of two antibiotic pastes used in root canal treatment without instrumentation

Evaluation of the sucess rate of two antibiotic pastes used in lesion sterilization and tissue repair: a randomized clinical study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-8m8754y
Enrollment
Unknown
Registered
2024-06-24
Start date
2024-08-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Pulp Diseases

Interventions

This study is a randomized, controlled, parallel, double-blind clinical trial. Therefore, the recommendations of the Consort Statement will be followed. The following criteria were used for sample cal
E06.397.778

Sponsors

Faculdade de Odontologia de Piracicaba da Universidade Estadual de Campinas
Lead Sponsor
Faculdade de Odontologia de Piracicaba da Universidade Estadual de Campinas
Collaborator

Eligibility

Age
3 Years to 11 Years

Inclusion criteria

Inclusion criteria: Children aged 3 to 11 years; no distinction between the sexes; with at least one deciduous molar diagnosed with irreversible pulpitis or pulp necrosis and internal or external resorption; sufficient tooth structure to allow absolute isolation of the operative field and rehabilitation with a stainless steel crown

Exclusion criteria

Exclusion criteria: Children who present any systemic alteration; history of allergic reaction to the components of the pastes to be studied; and have used antibiotics in the last three months from the date of the exam; patients with systemic manifestations (fever and extra-oral abscess) resulting from the infectious process of dental origin or teeth that present obliteration of the pulp canal; impairment of the bone crypt of the permanent tooth; coronary destruction that makes absolute isolation with a rubber dam and/or rehabilitation with a stainless steel crown impossible

Design outcomes

Primary

MeasureTime frame
It is expected that a significant difference will be observed in the performance of antibiotic pastes (3MIX and CTZ) at 15 days, 3, 6 and 12 months after treatment of primary teeth, with a higher rate of resolution of signs and symptoms associated with the infectious and inflammatory process. with absence of spontaneous pain, changes in soft tissues, fistula, edema and pathological tooth mobility when using 3MIX paste compared to CTZ;

Secondary

MeasureTime frame
Significantly greater reduction or stabilization of pathological radiolucent areas associated with infection and inflammation events observed radiographically by visual analysis and quantitative analysis is expected when using 3MIX paste compared to CTZ;;It is expected that the overall success rate when using 3MIX paste after 12 months of evaluation is higher than when using CTZ.

Countries

Brazil

Contacts

Public ContactPatrícia de Souza

Faculdade de Odontologia de Piracicaba da Universidade Estadual de Campinas

patricia.vittor@gmail.com+55 (19) 2106-5286

Outcome results

None listed

Source: REBEC (via WHO ICTRP)