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Success rate of inflamed and necrotised teeth treated with the product LUM01 compared with similar products

Success rate of teeth with apical Periodontitis treated with LUM01: A randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-8vc5r8b
Enrollment
Unknown
Registered
2023-03-03
Start date
2023-05-01
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 Necrosis

Interventions

This is a prospective, randomized, controlled, non-blinded clinical study. 198 patients will be included, with 1:1:1 randomization in 3 groups, with 66 patients in each group, 1 experimental group and
E06.397.778

Sponsors

Universidade Federal Fluminense
Lead Sponsor
Universidade Federal Fluminense
Collaborator

Eligibility

Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: Diagnosis of necrosis with periapical lesion that will be confirmed by a negative response to pulp sensitivity tests (cold and hot tests), and radiographic evidence of periradicular bone resorption (periapical lesion); Apexes completely closed; Need for endodontic treatment; Anatomical classification in relation to curvature classes I or II (Schneider, 1971); Age between 18 and 90 years.

Exclusion criteria

Exclusion criteria: Patients with indication for endodontic retreatment; Images suggestive of periradicular lesions with diameters greater than 8 mm; Patients who used antibiotic therapy, immunosuppressive drugs and anti-inflammatories in the last three months; Teeth with root fractures, with previous endodontic treatment, with the presence of periodontal pockets, with anatomical complexities such as, for example, very pronounced curvatures, dystrophic calcifications, among others, with crown fracture or very extensive caries that would prevent adequate absolute isolation; Pregnant and lactating patients; Patients with systemic and oral diseases that could influence the natural course or treatment of the disease, eg AIDS, diabetes, etc; Patients with systemic conditions requiring prophylactic antibiotic coverage.

Design outcomes

Primary

MeasureTime frame
To evaluate the success rate of the treatment based on the clinical symptoms and radiographic findings in 36 months post procedure.—

Secondary

MeasureTime frame
To evaluate the immediate and 7-day postoperative pain intensity—

Countries

Brazil

Contacts

Public ContactGustavo de Deus

Universidade Federal Fluminense

endogus@gmail.com+552126299900

Outcome results

None listed

Source: REBEC (via WHO ICTRP)