Trials / Completed
CompletedNCT03878173
Evaluation of Post-operative Discomforts in Children After Extraction of Temporary Teeth
Evaluation of Post-operative Discomforts in Children After Extraction of Temporary Teeth _ DEXTRAFANT _ RC16_0183
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 125 (actual)
- Sponsor
- Nantes University Hospital · Academic / Other
- Sex
- All
- Age
- 2 Years – 15 Years
- Healthy volunteers
- —
Summary
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
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.
Conditions
- Post-extraction Pain (PEP)
- Post-extraction Lip or Cheek Biting Injury (PEBI)
- Post-extraction Bleeding (PEB)
- Tooth Removal
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | No intervention | No intervention |
Timeline
- Start date
- 2016-04-01
- Primary completion
- 2017-06-30
- Completion
- 2017-06-30
- First posted
- 2019-03-18
- Last updated
- 2019-03-19
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT03878173. Inclusion in this directory is not an endorsement.