Evaluation of the effect of medications in the treatment of dental infections in healthy patients and patients who have undergone radiotherapy to the head and neck region

Clinical evaluation of intracanal medications on lipid mediators, inflammatory cytokines and effect on bacteria and products in endodontic infections of healthy patients or treated with head and neck radiotherapy

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

REBEC

Registry ID

RBR-6j98hjx

Enrollment

Unknown

Registered

2025-10-20

Start date

2022-03-06

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

Periapical Periodontitis

Interventions

This randomized controlled clinical trial with four arms (Subproject 1) and three arms (Subproject 2), double-blind, will evaluate in teeth with apical periodontitis the antimicrobial activity and the

D01.045.250.313

D27.505.954.122.085

D02.886.030.230.259

D02.078.370.141.100

Eligibility

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Permanent teeth; primary endodontic infection; single-rooted teeth with a single canal; periapical lesion; both genders; patients over 18 years of age

Exclusion criteria

Exclusion criteria: Periodontal pocket greater than 4 mm; teeth that cannot be isolated; root fracture or pulp chamber exposure; use of antibiotics or antifungal agents within 3 months prior to the start of treatment; presence of systemic disease

Design outcomes

Primary

Measure	Time frame
Primary Outcome: It is expected to find a reduction in the intracanal microbial load, measured by the colony-forming unit count (CFU/mL), associated with the modulation of the inflammatory and bone response, evaluated through the quantification of pro-inflammatory and anti-inflammatory cytokines, bone remodeling markers, and inflammatory lipid mediators before and after the application of the tested intracanal medications.	—

Measure

Time frame

Primary Outcome: It is expected to find a reduction in the intracanal microbial load, measured by the colony-forming unit count (CFU/mL), associated with the modulation of the inflammatory and bone response, evaluated through the quantification of pro-inflammatory and anti-inflammatory cytokines, bone remodeling markers, and inflammatory lipid mediators before and after the application of the tested intracanal medications.

—

Secondary

Measure	Time frame
It is expected that the medications associated with N-acetylcysteine will reduce more inflammatory cytokines and stimulate lipid mediators for the resolution of the inflammatory process.	—

Countries

Brazil

Contacts

Public ContactMarcia Valera

Instituto de Ciência e Tecnologia de São José dos Campos da Universidade Estadual Paulista

marcia.valera@unesp.br+55-12-39479078

Outcome results

None listed

Source: REBEC (via WHO ICTRP)