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Evaluation of the effect of different methods of topical anesthesia during the anesthesia procedure before dental treatment in children requiring treatment of primary molar teeth

Evaluation of the effect of different methods of topical anesthesia on pain during infiltrative anesthetic puncture in children requiring dental treatment of primary molars: a randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-74w5bt4
Enrollment
Unknown
Registered
2025-03-12
Start date
2025-01-20
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

Pain Perception

Interventions

This is a randomized controlled clinical study with two parallel arms, open-label. Only the evaluator, who has been previously calibrated in pain and behavior observation scales, will remain blinded.
E02.258

Sponsors

Universidade Federal de Santa Catarina
Lead Sponsor
Universidade Federal de Santa Catarina
Collaborator

Eligibility

Age
6 Years to 9 Years

Inclusion criteria

Inclusion criteria: Children aged 6 to 9 years; without systemic impairment (information provided by guardians); ASA I and II; of both sexes; with or without experience in dental care; who need dental treatment on lower deciduous molars, under local anesthesia, including restorations with absolute isolation, endodontic treatment or extraction; patients who will be referred for care at the Supervised Internship for Children and Adolescents (ESCA) clinic, a discipline linked to the undergraduate clinic in Dentistry at the Federal University of Santa Catarina (UFSC)

Exclusion criteria

Exclusion criteria: Patients with odontogenic infection associated with systemic signs and symptoms; acute pain or dental urgency; reported history of allergy to drugs used in the research (topical anesthesia and anesthetic solution) or components of absolute isolation (in cases requiring restorative or endodontic treatment); reported history of respiratory disease; reported history of hemorrhage or problems

Design outcomes

Primary

MeasureTime frame
The pain reported after using cryotherapy as a topical anesthetic is expected to be less than or equal to the pain reported after using benzocaine gel 20% as a topical anesthetic

Secondary

MeasureTime frame
Assess the child's behavior during the procedure using the Frankl Behavior Scale;Assess the anxiety of children before the procedure using the Facial Image Scale ;Assess the child's bodily reactions to the pain felt during the anesthetic puncture using the Face, Legs, Activity, Cry, Consolability Scale

Countries

Brazil

Contacts

Public ContactMichely Goebel

Universidade Federal de Santa Catarina

michelycristina_goebel@yahoo.com.br+55(48)37219000

Outcome results

None listed

Source: REBEC (via WHO ICTRP)