Skip to content

Pulp Therapy with Two Antibiotic Pastes - Randomized Clinical Trial

Non-Instrumental Technique with two Antibiotic Pastes - Randomized clinical trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
REBEC
Registry ID
RBR-5w2fsx4
Enrollment
Unknown
Registered
2025-03-17
Start date
2025-01-06
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 Necrosis

Interventions

This is a randomized, non-inferiority, parallel, double-blind clinical trial. The sample was defined as 46 teeth per group, totaling 92 teeth. Study participants will be randomly allocated into two gr
and Group 2 (CZ paste), composed of chloramphenicol and zinc oxide, with eugenol as the vehicle. Simple randomization will be performed using software
participants will be allocated to one of the intervention groups, and each tooth will receive a five-digit code, present in all participant records. The tooth identification codes will be placed in op
E06.397.778

Sponsors

Universidade Federal do Piauí
Lead Sponsor
Universidade Federal do Piauí
Collaborator

Eligibility

Age
3 Years to 7 Years

Inclusion criteria

Inclusion criteria: Children of both sexes; aged 3 to 7 years; who have lower deciduous molars with a clinical and radiographic diagnosis of irreversible pulpitis or pulp necrosis; physiological root resorption equal to or less than 1/2 and sufficient dental structure for absolute isolation of the operating field and adaptation of a steel crown

Exclusion criteria

Exclusion criteria: Children with teeth with calcific metamorphosis; pathological internal or external root resorption visible on periapical radiographs; history of allergic reaction to toothpaste components; use of antibiotics in the month prior to treatment and immunocompromised children

Design outcomes

Primary

MeasureTime frame
Infection control of primary molars with necrotic pulp is expected after intervention with antibiotic pastes. The primary outcome is clinical and radiographic success.

Secondary

MeasureTime frame
A reduction or stabilization of the radiolucency halo in the furcation region of lower deciduous molars with pulp necrosis is expected and it is assessed whether it influences the effectiveness of pulp therapy.

Countries

Brazil

Contacts

Public ContactCaroline Barros Oliveira

Universidade Federal do Piauí

krolineb@gmail.com+55 (86) 22224824

Outcome results

None listed

Source: REBEC (via WHO ICTRP)