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The use or not of needles to anesthetize patients with pulpal inflammation

Use of oral anesthesia with and without the aid of needles in patients with inflammation in the dental pulp: a Randomized Clinical Study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-107dyj7w
Enrollment
Unknown
Registered
2022-06-30
Start date
2021-03-08
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

Postoperative Pain

Interventions

The patient will be allocated to the COMFORT-IN GROUP or the NEEDLE GROUP according to the number that appears on the chosen envelope, and each group will have 31 patients, resulting in 62 patients in
VS3.003.001.006.001

Sponsors

Universidade CEUMA (Centro Universitário do Maranhão)
Lead Sponsor
Universidade CEUMA (Centro Universitário do Maranhão)
Collaborator

Eligibility

Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: To be eligible for this study, patients must have the following characteristics: Patient who volunteered to participate in the study, aged between 18 and 50 years; Presence of permanent maxillary molars and premolars with diagnosis of symptomatic irreversible pulpitis (Patient with history of nocturnal pain or spontaneous pain and cold pulp sensitivity test with positive response and slow decline); Systemically healthy patient

Exclusion criteria

Exclusion criteria: The following will be excluded from the research: lower teeth; teeth that present trauma; teeth with periodontal alterations (pocket with more than 3 mm, mobility and gingival edema); teeth with pain on apical palpation and teeth with pulp necrosis; patients who are allergic to sulfonamides; patients with uncontrolled diabetes; patients with uncontrolled hypertension; patients with myocardial infarction aged less than 6 months; pregnant women due to the risk of methemoglobinemia.

Design outcomes

Primary

MeasureTime frame
Evaluate the absence of pain (anesthetic success/anesthetic capacity) during the emergency endodontic procedure, both for the needleless technique and for the needle technique. The verification will be done with the help of the cold thermal test and the electrical test performed immediately after anesthetized, 30 minutes and 1 hour after its start. The parameter used for the thermal test is the negative response to the application of the stimulus and for the electrical test it is the value of 50 for premolars and 70 for molars, according to the reaction scale of the equipment itself.

Secondary

MeasureTime frame
To evaluate the postoperative pain of the urgent endodontic procedure, both for the needleless technique and for the needle technique. The verification will be done through the VAS Scale (Visual Analogue Scale) that the patient will take home and will fill in at 6, 12, 24, 48 and 72 hours after the clinical session . The scale goes from 0 to 10, with 0 being our parameter for absence and pain and 10 being our parameter for extreme pain. After 72 hours, the scale will be collected by the research team.;To assess the impact on the patient's quality of life before and 7 days after emergency care, both for the needle-free and needle-based technique. Verification will be done by applying the OHIP-14 (Oral Health Impact Profile) before the procedure and 72 hours after the clinical session. The questionnaire consists of 14 questions about the patient's condition, ranging from diet to psychological changes, and the answers consist of: never, sometimes, rarely, always, often or I don't know how to answer. The parameter used to verify the improvement of the quality of life will be: in the first application the questions are answered sometimes, always, frequently and in the second application the answers are: never or rarely.;Evaluate the anesthesia latency time for the beginning of the emergency endodontic procedure, both for the needleless technique and for the needle technique. The verification will be done with the help of the cold thermal test and the electrical test performed at 2 minutes, 5 minutes, 30 minutes and 1 hour after its start. The parameter used for the thermal test is the negative response to the application of the stimulus and for the electrical test it is the value of 50 for premolars and 70 for molars, according to the reaction scale of the equipment itself.;Evaluate pain during the application of anesthesia, both for the needleless technique and for the needle technique. The verification will be done through the VAS Scale (Visual Analogue Scale), where t

Countries

Brazil

Contacts

Public ContactAmanda Palmeira Nogueira

Universidade CEUMA (Centro Universitário do Maranhão)

amandaarrudanogueira@gmail.com+55(98)981439301

Outcome results

None listed

Source: REBEC (via WHO ICTRP)