Dental PainADDenTNCT07718477
Compare the Intensity of Pain Felt by Children During the Local Anesthesia Procedure to That Perceived by the Accompanying Parent.
An observational study of Dental Pain and Dental Anxiety, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
The goal of this observational study is to compare the intensity of pain experienced by children (aged 6 to 15) during local anaesthesia with that perceived by the parent accompanying them. Read more about this study
- Who is it for?
- Ages 6 to 15 years
- Conditions the study is for
- Dental Pain, Dental Anxiety
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 8 Oct 2026to 8 Oct 2028
- Phase
- Observational
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 6 to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: Dental Department, Estaing University Hospital, Clermont-Ferrand
Who may be able to join
- Children aged 6 to 15
- Children requiring dental treatment involving local anaesthetic
- Children accompanied by at least one parent (or legal guardian)
- Children and parents who speak French fluently
Who cannot join
- Children under the age of 6 (complex self-assessment)
- Children over the age of 15 (no longer fall within the scope of paediatric dentistry)
- Children or accompanying parents who have difficulty understanding due to a limited command of French or any form of intellectual disability
- Children whose parents have not consented to their participation in the study
- Children who do not wish to participate in the study
- Unaccompanied children
- Children with an intolerance or allergy to local anaesthetics, vasoconstrictors or excipients
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Clermont-Ferrand
Clermont-Ferrand
Anne MISHELLANY-DUTOUR
About this study
The goal of this observational study is to compare the intensity of pain experienced by children (aged 6 to 15) during local anaesthesia with that perceived by the parent accompanying them. The main question it aims to answer is:
Can a parent help assess their child's pain when the child is unable to assess it themselves? A preliminary study carried out in the dentistry department of Clermont-Ferrand University Hospital in 2019 showed that parents could be effective external assessors in distinguishing between pain and anxiety in their own children, whom they know well, and were better at this than dentists, who are more prone to errors of judgement.13 This pilot study covered several dental procedures, including pulpotomy, extraction of a primary tooth, curettage of a carious lesion and dental anaesthesia. The study yielded interesting results but also contained some biases, so the investigators would like to improve upon it. To do so, the focus here is on a single therapeutic procedure: local anaesthesia, which is one of the procedures most feared by children and, very often, by the parents accompanying them as well.
Once consent has been obtained from both parents (or legal guardians), two questionnaires will be used. The first will consist of simple questions and will be aimed at the children (9 items). The second (20 items) will be for parents and will provide additional information on the child's state of health and on the parents' anxiety regarding their own dental care and that provided to their child. The main aim of both questionnaires will be to assess the intensity of pain perceived by the child during the administration of local anaesthesia, with the child self-reporting their pain and the parent providing an external assessment. These questionnaires will be completed every Wednesday, which allows a child (requiring multiple treatments) to complete the questionnaires several times, thereby enabling us to observe changes in the pain perceived by the child and their accompanying parent over the course of successive anaesthetic procedures.
- Conditions
- Dental Pain, Dental Anxiety
- Keywords
- pediatric odontology, dental pain assessment, anxiety, children, parents
- Medical subject headings
- Toothache, Anxiety Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of pain (Numerical Rating Scale: NRS) as reported by the child and as perceived by the parent
Pain intensity assessed using a 0-10 Numerical Rating Scale (NRS), as self-reported by the child and independently rated by the parent according to their perception of the child's pain.
Measured: Day 1
Secondary outcomes (5)
Assessment of anxiety in children and parents regarding dental anaesthesia (Numerical Rating Scale: NRS)
Anxiety related to dental anaesthesia assessed using a 0-10 Numerical Rating Scale (NRS), as self-reported by the child and independently self-reported by the parent.
Measured: Day 1
To investigate the correlation between 2 measurements: anxiety (Numerical Rating Scale: NRS) about dental treatment and the assessment of pain intensity (Numerical Rating Scale: NRS)
Association between anxiety related to dental treatment and pain intensity, both assessed using a 0-10 Numerical Rating Scale (NRS). Correlation analysis will be performed to evaluate the relationship between these two measures reported by the children and their accompanying parents (or legal guardians), depending on normality of data, correlation will be assessed using Pearson or Spearman coefficient
Measured: Day 1
Create a categorical score for children with multiple medical conditions and pain during anaesthesia
The medical score will equal the weighted sum of medical conditions (0 = absence, 1 moderate, 2 severe for each condition), and that score will be correlated with pain score using either Pearson or Spearman coefficient depending on normality of data
Measured: Day 1
To investigate the correlation between 2 measurements: pre-operative pain history (Numerical Rating Scale: NRS) and the assessment of pain intensity (Numerical Rating Scale: NRS)
The association between pre-operative pain history and pain intensity during dental anaesthesia will be evaluated. Pre-operative pain history and pain intensity will both be assessed using a 0-10 Numerical Rating Scale (NRS). Correlation analysis will be performed to evaluate the relationship between these two measures, depending on normality of data, correlation will be assessed using Pearson or Spearman coefficient
Measured: Day 1
Monitor changes in pain intensity from the first anaesthetic administration to the last, should the patient return for treatment (Numerical Rating Scale: NRS)
Changes in pain intensity will be assessed using a 0-10 Numerical Rating Scale (NRS) by comparing pain scores reported during the first dental anaesthesia session with those reported during the last anaesthesia session in children who return for subsequent treatment, by using either a pearson/spearman correlation or an Intra Class correlation, similarly to a test-retest assessement.
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 posted22 Jul 2026
- Study start8 Oct 2026
- Primary completion8 Oct 2028 (estimated)
- Study completion8 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental PainStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Université d'Auvergne, Institut National de la Santé Et de la Recherche Médicale, France, Laboratory NeuroDol U1107 Inserm
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07718477
- Sponsor's protocol ID
- RNI 2025 DUTOUR
- Acronym
- ADDenT
- Status last verified
- Oct 2026
- First submitted
- 2 Jul 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No