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ADDenT
Sponsor study identifier
observational
100
1 country
1
Study Start
October 8, 2026
Actual (reported)Primary Completion
October 8, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
October 8, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 8, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2, 2026
Actual (reported)July 22, 2026
Actual (reported)October 8, 2026
Actual (reported)October 8, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
October 8, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Day 1
Assessment of anxiety in children and parents regarding dental anaesthesia (Numerical Rating Scale: NRS)
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)
Day 1
Create a categorical score for children with multiple medical conditions and pain during anaesthesia
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)
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)
Day 1
Dental Department, Estaing University Hospital, Clermont-Ferrand
CHU Clermont-Ferrand
Clermont-Ferrand, France
First Submitted
July 2, 2026
First Posted
July 22, 2026
Study Start
October 8, 2026
Actual (reported)Primary Completion
October 8, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Contact the study team to confirm eligibility.
Study Completion
October 8, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 13, 2026
Record last verified: 2026-10
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Source: ClinicalTrials.gov.
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