Evaluation of Post-operative Discomforts in Children After Extraction of Temporary Teeth

Study Overview
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Brief Summary
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This prospective observational study aim to evaluate discomforts after extraction of temporary tooth under local anesthesia. The first objective is to describe the prevalence of the post-extraction pain (PEP), post-extraction bleeding (PEB), post-extraction biting injury (PEBI) in children, and the analgesic usage. The secondary objective is to define whether it is possible to determine a profile of patients or a type of extraction's procedure predictive to PEP and administration of analgesics, PEB or PEBI.

Detailed Description
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125 children in range of 2-15 years indicated for tooth extractions will be included in this study. Informed consent will be obtained from all individual participants included in this study. Immediately after extraction and until the following day, parents will be asked to assess the post-operative discomforts and to administrate paracetamol (acetaminophen) as soon as the child expressed a pain score ≥2 evaluated on the faces pain scale-revised (FPS-R). A structured form is designed to obtained information regarding the patient's age, gender, socioeconomic level, and cooperation of the child before and during anesthesia or extraction, influence of accompanying person, number of previous extraction, dental hygiene. Moreover, details about the type of extraction; the indication of extraction (tooth decay, orthodontic treatment, obstacle, infection and traumatism), the type of tooth (incisor-canine or molar), the degree of root resorption, number of doses of local anesthetic, and presence of preexisting or per-operative pain are also collected.

Official Title
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Evaluation of Post-operative Discomforts in Children After Extraction of Temporary Teeth _ DEXTRAFANT _ RC16_0183

Conditions
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Post-extraction Pain (PEP), Post-extraction Lip or Cheek Biting Injury (PEBI), Post-extraction Bleeding (PEB), Tooth Removal

Intervention / Treatment
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* Other: No intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: children in range of 2-15 years indicated for tooth extractions under local anesthesia. Exclusion Criteria: patient under analgesic the day of the appointment or under non steroidal anti-inflammatory agents through 8 days before the extraction; contraindication to paracetamol/acetaminophen; incomplete mental health; extraction under sedation (including nitrous oxide/oxygen) and under general anesthesia. extractions of permanent tooth; Child was also excluded from the study if parents could not be reached by phone within 32 hours after extraction and if the parents don't speak French.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: No intervention|No intervention|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prevalence and severity of pain after extraction of deciduous teeth | pain evaluated on the EVA faces pain scale-revised | 32 hours post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of a profile of patients predictive to PEP and administration of analgesics, PEB or PEBI | % of patient's by class of: age, gender, socioeconomic level, and cooperation of the child before and during anesthesia or extraction, influence of accompanying person, number of previous extraction, dental hygiene. | Day 1 | 
| Determination of a profile of a type of extraction's procedure predictive to PEP and administration of analgesics, PEB or PEBI | % of patient's by class of: type of extraction; the indication of extraction (tooth decay, orthodontic treatment, obstacle, infection and traumatism), the type of tooth (incisor-canine or molar), the degree of root resorption, number of doses of local anesthetic, and presence of preexisting or per-operative pain are also collected immediately after the tooth extraction. | Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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temporary tooth, pain, analgesic, paracetamol, acetaminophen