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

Post-extraction Bleeding (PEB) Clinical Trial

— DEXTRAFANT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03878173
• Other study ID #: RC16_0183
• Status: Completed
• Start date: April 1, 2016
• Est. completion date: June 30, 2017

Study information

• Verified date: March 2019
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: June 30, 2017
• Est. primary completion date: June 30, 2017
• Gender: All
• Age group: 2 Years to 15 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire de Nantes	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	prevalence and severity of pain after extraction of deciduous teeth	pain evaluated on the EVA faces pain scale-revised	32 hours post-operatively
Secondary	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
Secondary	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