Post-extraction Pain (PEP)DEXTRAFANTNCT03878173
Evaluation of Post-operative Discomforts in Children After Extraction of Temporary Teeth
An observational study of Post-extraction Pain (PEP) and Post-extraction Lip or Cheek Biting Injury (PEBI), run by Nantes University Hospital at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 2 to 15 years
- Conditions the study is for
- Post-extraction Pain (PEP), Post-extraction Lip or Cheek Biting Injury (PEBI), Post-extraction Bleeding (PEB)
- How many people
- 125 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2016to 30 Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 15 years
- All sexes
- Child
Study population: 125 children in range of 2-15 years indicated for tooth extractions will be included in this study.
Who may be able to join
- children in range of 2-15 years indicated for tooth extractions under local anesthesia.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- No intervention
- Keywords
- temporary tooth, pain, analgesic, paracetamol, acetaminophen
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence and severity of pain after extraction of deciduous teeth
pain evaluated on the EVA faces pain scale-revised
Measured: 32 hours post-operatively
Secondary outcomes (2)
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.
Measured: 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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2019
- Study start1 Apr 2016
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-extraction Pain (PEP)Studies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brigitte Alliot-Licht, Dr, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03878173
- Sponsor's protocol ID
- RC16_0183
- Acronym
- DEXTRAFANT
- Status last verified
- Mar 2019
- First submitted
- 12 Mar 2019
- Last updated
- 19 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Post-operative Discomforts in Children After Extraction of Temporary Teeth _ DEXTRAFANT _ RC16_0183
- ClinicalTrials.gov ID
- NCT03878173
- Acronym / sponsor ID
- DEXTRAFANT / RC16_0183
- Conditions
- Post-extraction Pain (PEP), Post-extraction Lip or Cheek Biting Injury (PEBI), Post-extraction Bleeding (PEB), Tooth Removal
- Keywords
- temporary tooth, pain, analgesic, paracetamol, acetaminophen
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 18 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 to 15 years
- Sex
- All
- Age groups
- Child
- Study population
- 125 children in range of 2-15 years indicated for tooth extractions will be included in this study.
Key inclusion criteria (1 listed)
- children in range of 2-15 years indicated for tooth extractions under local anesthesia.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | – |
Primary outcome
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
2 secondary outcomes
Determination of a profile of patients predictive to PEP and administration of analgesics, PEB or PEBI
Time frame: Day 1
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2019.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brigitte Alliot-Licht, Dr principal investigator
Nantes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-extraction Pain (PEP) and Post-extraction Lip or Cheek Biting Injury (PEBI), run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence and severity of pain after extraction of deciduous teeth (time frame: 32 hours post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2019.