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

NCT ID: NCT03878173

Last Updated: 2019-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

125 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-04-01

Study Completion Date

2017-06-30

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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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No intervention

No intervention

Intervention Type OTHER

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.
Minimum Eligible Age

2 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Brigitte Alliot-Licht, Dr

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Locations

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Centre Hospitalier Universitaire de Nantes

Nantes, , France

Site Status

Countries

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France

Other Identifiers

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RC16_0183

Identifier Type: -

Identifier Source: org_study_id

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