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Completed

NCT Number: NCT03878173

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

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.

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Key information

Age range

2 year–15 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Universitaire de Nantes

Nantes, 44093, France

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. prevalence and severity of pain after extraction of deciduous teeth

    Time frame: 32 hours post-operatively

    pain evaluated on the EVA faces pain scale-revised

Secondary outcomes

  1. Determination of a profile of patients predictive to PEP and administration of analgesics, PEB or PEBI

    Time frame: Day 1

    % 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.

  2. Determination of a profile of a type of extraction's procedure predictive to PEP and administration of analgesics, PEB or PEBI

    Time frame: Day 1

    % 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.

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

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

Acronym: DEXTRAFANT

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 18, 2019
Registry last updated
Mar 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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