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

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

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.

Study Overview

• Status: Completed
• Conditions: Post-extraction Pain (PEP); Post-extraction Lip or Cheek Biting Injury (PEBI); Post-extraction Bleeding (PEB); Tooth Removal
• Intervention / Treatment: Other: No intervention

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.

• Study Type: Observational
• Enrollment (Actual): 125

Contacts and Locations

Study Locations

• France
  • Nantes, France, 44093
    • Centre Hospitalier Universitaire de Nantes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 15 years (Child)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

125 children in range of 2-15 years indicated for tooth extractions will be included in this study.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Investigators: Principal Investigator: Brigitte Alliot-Licht, Dr, Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Actual): June 30, 2017
• Study Completion (Actual): June 30, 2017

Study Registration Dates

• First Submitted: March 12, 2019
• First Submitted That Met QC Criteria: March 13, 2019
• First Posted (Actual): March 18, 2019

Study Record Updates

• Last Update Posted (Actual): March 19, 2019
• Last Update Submitted That Met QC Criteria: March 15, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: analgesic; pain; acetaminophen; paracetamol; temporary tooth
• Other Study ID Numbers: RC16_0183

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No