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Results of non-surgical endodontic treatment in teeth with apical periodontitis after use of intracanal bioceramic medication

Outcomes of nonsurgical Endodontic Treatment in teeth with apical Periodontitis after the use of a Bioceramic intracanal medication: a randomized clinical trial

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
REBEC
Registry ID
RBR-5cz39kj
Enrollment
Unknown
Registered
2025-11-18
Start date
2025-10-08
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Periapical Periodontitis

Interventions

This is a randomized, controlled, parallel clinical trial with three arms and blinded assessor that will include 90 adult patients with asymptomatic apical periodontitis in single-rooted teeth with a
Group 2, active comparator, with a total of 30 participants receiving intracanal application of calcium hydroxide paste prepared with glycerin
and Group 3, active comparator, with a total of 30 participants receiving intracanal application of calcium hydroxide paste prepared with 2% chlorhexidine solution, all medications being inserted with
obturation will be performed after complete removal of the medication
microbiological samples will be collected before instrumentation (S1), after instrumentation (S2), and after the seven-day intracanal medication period (S3), and the evaluator responsible for the micr

Sponsors

Fundação Universidade de Pernambuco
Lead Sponsor
Fundação Universidade de Pernambuco
Collaborator

Eligibility

Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Single-rooted teeth with a single root canal diagnosed, with necrotic pulp and clinical and radiographic evidence of asymptomatic apical periodontitis in untreated teeth

Exclusion criteria

Exclusion criteria: Teeth exhibiting cracks or root fractures; teeth with extensive coronal caries destruction that cannot be restored or isolated; patients presenting painful symptoms; painful periapical abscess; periodontal pockets greater than 4 mm in depth; complex anatomies of the root canal system; internal or external root resorption; Immature teeth; calcified canals; any surgical accident resulting in the inability to achieve foraminal patency; participants unavailable for follow-up visits; participants continuously using nonsteroidal anti-inflammatory drugs or corticosteroids; participants unable to understand and cooperate with study procedures or provide informed consent; participants with a significant systemic disease in their medical history

Design outcomes

Primary

MeasureTime frame
It is expected to observe a statistically significant reduction in the total intracanal bacterial load after the use of the medications tested, quantified by qPCR, quantitative polymerase chain reaction, directed at the 16S rRNA (ribosomal ribonucleic acid) gene, comparing the samples collected before (S1, sample 1), after the chemical-mechanical preparation (S2, sample 2) and after the seven-day period of intracanal medication (S3, sample 3)

Secondary

MeasureTime frame
To evaluate and compare the incidence and intensity of postoperative pain in the periods of 24 hours, 48 hours, 72 hours and 7 days after the use of intracanal medications, using the Visual Analog Scale and the Numerical Pain Rating Scale ;To evaluate and compare the clinical and radiographic success of endodontic treatment after the use of different intracanal medications, based on clinical and radiographic success criteria at 6 and 12 months, using the Periapical Index of Ørstavik et al 1986

Countries

Brazil

Contacts

Public ContactNatália de Oliveira

Faculdade de Odontologia de Pernambuco – Universidade de Pernambuco (FOP UPE)

natalia.gomes@upe.br+55(81)99246-8793

Outcome results

None listed

Source: REBEC (via WHO ICTRP)