Dental Fistula
Conditions
Interventions
A total of 64 children will be included, 32 in the experimental group and 32 in the control group. Experimental group: 32 children that requiring extraction in mandibular deciduous molars will receive
E06.892
E03.155.086.231
Sponsors
Universidade Federal de Santa Catarina
Universidade Federal de Santa Catarina
Eligibility
Age
6 Years to 9 Years
Inclusion criteria
Inclusion criteria: Children between 6 and 9 years of age, without systemic involvement, ASA I and II, of both sexes, who have a clinical and radiographic indication for extraction of an erupted primary molar and lower molar and who agree to participate in the research. Each child will participate only once in the survey. The following clinical and radiographic inclusion criteria will be analyzed. Clinically: the presence of coronary destruction that makes restoration impossible or the proper use of absolute isolation for endodontic and restorative procedures; the presence of perforation of the pulp chamber floor. Radiographically; deciduous molars with carious lesions or defective restorations associated with signs or symptoms indicative of pulp necrosis, periapical or inter radicular lesion extending over 1/3 of the roots or involving the crypt of the permanent successor tooth; the presence of pathological resorption of more than 1/3 of one or more roots that contraindicate endodontics; the presence of at least one non-resorbed half-length root, previous endodontic failure the persistence of periapical or inter radicular lesion associated or not with clinical signs and symptoms; internal resorption.
Exclusion criteria
Exclusion criteria: Patients with acute pain or presence of odontogenic infection associated with systemic signs and symptoms and cases of urgency; Patients with a history of bleeding or blood clotting problems or who have used medication that alters blood clotting prior to the procedure; Patients with hypersensitivity or a history of allergy to the drugs used in the research; Patients with a history of asthma; Patients with a history of liver disease;Patients with a history of bisulfite allergy; Patients who have reported post-traumatic stress disorder or recurrent hospitalizations, who have a personality or anxiety disorder or a diagnosis of phobia; Patient with neurological disorders or communication difficulties; Patient whose guardian cannot accompany the child and answer the necessary information for the survey within 24 hours following the procedure.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome evaluated will be the anesthetic efficacy of the vestibular infiltration technique compared to the inferior alveolar nerve block technique, both using 2% lidocaine with 1:100 000 epinephrine, by measuring self-reported pain at the time of tooth dislocation through the Visual Analog Scale (VAS). The scale will be applied to the child during the tooth extraction, right after the tooth is removed from the socket. It is expected to observe that the difference between the control group and the intervention group is not significant, considering that it does not exceed the acceptable inferiority limit. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Pain measurement during the operative procedure via Visual Analogue Scale (VAS). The scale will be applied shortly after infiltrative anesthesia. The child will answer the scale.;2. Pain during the operative procedure via Face, Legs, Activity, Cry, Consolability (FLACC): The scale will be used during anesthesia at the time of anesthetic injection and during extraction, at the time of tooth dislocation.;3. Children's anxiety before the procedures (Facial Image Scale - FIS) and caregivers' anxiety before the procedures (Dental Anxiety Scale - DAS). The FIS will be presented to the child before the extraction procedure. The DAS scale will be applied to those responsible before the extraction procedure.;4. Children's behavior during the procedure was evaluated with Frankl and Venham's scale. A trained and calibrated evaluator will apply the Frankl scale and the VBRS, during the anesthetic injection and during tooth dislocation, in addition to this, the global score of the behavior during the service will also be evaluated. ;5. Pain during the operative procedure via Faces Pain Scale-Revised (FPS-R): The scale will be used during anesthesia at the time of anesthetic injection and during extraction, at the time of tooth dislocation.;6. Analysis of local adverse events after local anesthesia by direct assessment or by reporting by the person in charge: to verify the frequency of local and systemic adverse events after local anesthesia using the different techniques. The caregivers will be contacted after 24h by telephone. You will also be asked if there was a need to use analgesic medication in the period due to the procedure.;7. Parent's Sense of Coherence (SOC): will be measured using the short version of the SOC scale (SOC-13). Those responsible will answer the questionnaire.;8. Identify the influence of parents' income and education on children's perception of pain after tooth extraction. Parents will answer the questionnaire referring to data related to the socioec | — |
Countries
Brazil
Contacts
Public ContactLuiz ;Mariane Toledo;Cardoso
Universidade Federal de Santa Catarina;Universidade Federal de Santa Catarina
Outcome results
None listed