Child
Conditions
Interventions
The present study was conducted as a two-arm controlled and randomized clinical trial. The pharmacological presentation of the drugs under study does not allow for the study to be blind or double-blin
D01.625.550.550
Sponsors
Faculdade de Odontologia de Piracicaba - Unicamp
Faculdade de Odontologia de Piracicaba - Unicamp
Eligibility
Age
5 Years to 12 Years
Inclusion criteria
Inclusion criteria: Children classified according to the American Society of Anesthesiologists (ASA) in ASA I – healthy patient; Both sexes; Child aged between five and twelve years; Accompanied by their parents/guardians, who presents bad behavior, fear and/or anxiety that are resistant to dental treatment, postponing the clinical procedure; Difficulty or behavioral management problems that provide a challenge to the dental surgeon in practice clinic; When basic techniques (voice control, speak-show-do, and protective stabilization) are not permitted or cannot be carried out effectively and safely, due to control of behavior is not enough; No communication difficulties; Children who need simple extraction of deciduous molars, which have at least 2/3 of the root; With periapical radiography of the tooth that will be extracted; Children who accept the mask and collaborate with the technique.
Exclusion criteria
Exclusion criteria: Pre-collaborative children; History of taking medication for pain or anxiety in the 15 days prior to the study; Allergy to drugs, substances or materials used in this experiment; Patients with respiratory tract infections such as the common cold, tonsillitis or nasal obstruction; Mouth breathers due to nasal adenoids; Patient with pneumothorax, cystic fibrosis, infection or recent middle ear surgery and bladder obstruction; Patients who do not accept the mask; Child with chronic obstructive pulmonary disease; Heart disease; Patients with sinusitis or surgeries otolaryngology in the last 14 days; Patients with a strong gag reflex; Patients with disorders muscle tone (cerebral palsy); Presence or suspicion of tumors; Children undergoing chemotherapy use bleomycin or have used it for less than 1 year; Radiotherapy; Osteomyelitis; Psychotic patients; Patients with porphyria; Children whose parents refuse to collaborate with research; Children who do not does not let you touch at all and/or does not sit in the chair; Children who do not accept to participate in the search.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected Outcome 1: It is expected that sedation with Passiflora incarnata L. will be safe and effective in a manner similar to sedation with nitrous oxide/oxygen, as assessed by the evaluation of anxiety using the Modified Child Dental Anxiety Scale - Faces (MCDASf) and monitoring of heart rate. With a magnitude difference of 20% between the two proposed anxiety control protocols and a standard deviation of 30% from the mean, 15 volunteers were required for the study to provide a statistical power of 95%, with a significance level of 5%.;Outcome found 1: It was observed that sedation with Passiflora incarnata L. was safe and effective in a manner similar to sedation with nitrous oxide/oxygen. This was confirmed by the comparison of the two groups, which was not statistically significant (p=0.19) according to the Mann-Whitney test referring to the MCDASf scale, and by the mean of heart rates confirmed by the two-way ANOVA test (p=0.32). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes were not expected. | — |
Countries
Brazil
Contacts
Public ContactFaculdade de Odontologia de Piracicaba - Unicamp
Faculdade de Odontologia de Piracicaba - Unicamp
Outcome results
None listed