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Assessment of a cryotherapy crpotocol on the occurrence of postoperative endodontic pain in molars with irreversible pulpitis: a randomized clinical trial

Assessment of a cryotherapy protocol on the occurrence of postoperative endodontic pain in molars with irreversible pulpitis: a randomized clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-5g4p9q8
Enrollment
Unknown
Registered
2024-04-29
Start date
2023-12-04
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

Pulpitis

Interventions

The 60 patients will be randomized using the block technique and stratified by sex. Masking will be double blind, in which the patient and the outcome investigator will be blinded. The experimental gr
E06.397.778
E02.258

Sponsors

Universidade Federal do Amazonas
Lead Sponsor
Universidade Federal do Amazonas
Collaborator

Eligibility

Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: The inclusion criteria will involve recruiting capable adult patients (18 to 65 years old) who already have an indication for endodontic treatment in permanent molars, diagnosed with irreversible pulpitis confirmed by a positive response to clinical, electrical sensitivity, and radiographic tests. Individuals participating in this research must provide a contact number (phone, cell phone, or social media username) to facilitate postoperative assessments. If a patient requires endodontic treatment for more than one tooth, the operator will follow the standard protocol; however, such cases will not be included in the study to avoid selection bias in the sample.

Exclusion criteria

Exclusion criteria: Patients in any stage of pregnancy, those currently taking medication such as analgesics or anti-inflammatories at the time of treatment, immunocompromised individuals, or those with hypersensitivity to non-steroidal anti-inflammatory drugs will not participate in the study. These factors may alter pain perception or interfere with the analysis of post-treatment pain scores. Patients with teeth presenting endodontic complications, such as calcifications, external or internal resorption, partial apex formation, dental perforations, longitudinal or vertical fractures, severe periodontal disease, or those undergoing treatment in multiple sessions, will also be ineligible for participation in this study. These factors can interfere with proper endodontic therapy and, consequently, with postoperative pain. Data from patients who cannot be contacted for postoperative pain assessment for any reason will be excluded.

Design outcomes

Primary

MeasureTime frame
To evaluate the occurrence and intensity of post-operative endodontic pain by applying a discrete numeric scale marked from zero (no pain) to 10 cm (maximum pain), in patients participating in the research over a period of 6, 12, 24, 48 and 72 hours after endodontic treatment.

Secondary

MeasureTime frame
It is expected to find a lower occurrence and intensity of postoperative pain in the intervention group, with a difference of 30% between the groups

Countries

Brazil

Contacts

Public ContactEmílio Carlos Sponchiado Júnor

Universidade Federal do Amazonas

spemilio@ufam.edu.br55(92)33054908

Outcome results

None listed

Source: REBEC (via WHO ICTRP)