An observational study in Child, Behaviour and Scale, sponsored by University of Valencia. Not yet recruiting at 1 site in Spain. Open to participants aged 4 Years to 10 Years. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by University of Valencia · Observational
This is a descriptive observational study aimed at evaluating the inter-rater agreement of four behavioral rating scales used in pediatric dentistry-the Houpt Scale, the Ohio State University Behavioral Rating Scale, the Venham Scale, and the Frankl Scale-for assessing children's behavior during dental treatment. The study will be based on the analysis of video recordings of clinical procedures.
The study will include 30 children aged between 4 and 10 years who attend the Pediatric Dentistry postgraduate training clinic at the University of Valencia for dental treatment. Only children whose parents or legal guardians have signed the informed consent form for participation in the study, the consent form authorizing the dental treatment, and the consent form authorizing the use of images will be included.
Children classified as ASA III or IV, children with neurological or cognitive disorders, and children whose parents do not agree to participation or do not sign the informed consent form will be excluded. Clinical situations in which video recording could interfere with the safety of the procedure or compromise the patient's well-being will also be excluded.
The dental treatment will be performed by students enrolled in the postgraduate program in Pediatric Dentistry and will consist of restorative treatment for dental caries requiring local anesthesia.
404 studies on the registry are indexed under Behavior; 167 are open to participants now.
This study's planned enrollment of 30 is below the median of 250 across 81 observational studies indexed under Behavior.
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The study will include 30 children aged between 4 and 10 years who attend the Pediatric Dentistry postgraduate training clinic at the University of Valencia for dental treatment. Only children whose parents or legal guardians have signed the informed consent form for participation in the study, the consent form authorizing the dental treatment, and the consent form authorizing the use of images will be included.
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Exclusion Criteria:
• Children requiring restorative treatment for dental caries under local anesthesia
Behavioral: Video recording
Video recordings will be made to capture the dental chair and its surroundings, including the patient, the dental professional performing the treatment, and the dental assistant. The recordings will also include audio to enable assessment of the interaction between the dental professional and the patient, as well as the patient's reactions at different stages of the procedure.
Overall behavior during dental treatment assessed with the Houpt Behavior Rating Scale.
Child behavior during restorative treatment of a primary tooth will be assessed using the overall behavior subscale of the Houpt Behavior Rating Scale. This subscale ranges from 1 to 6: 1 = aborted, no treatment rendered; 2 = poor, treatment interrupted and only partially completed; 3 = fair, treatment interrupted but eventually completed; 4 = good, treatment difficult but fully completed; 5 = very good, limited crying or movement; and 6 = excellent, no crying or movement. Higher scores indicate better overall behavior. Behavior will be independently rated by 3 trained raters using the standardized video recording of the dental appointment.
Time frame: During the dental treatment visit, from the start of the dental procedure until completion of treatment of the primary tooth.
Child behavior during dental treatment assessed with the Ohio State University Behavioral Rating Scale (OSUBRS).
Child behavior during restorative treatment of a primary tooth will be assessed using the Ohio State University Behavioral Rating Scale (OSUBRS). The scale classifies behavior into four mutually exclusive categories: 1 = quiet behavior, no movement; 2 = crying without struggling or disruptive movement; 3 = struggling or disruptive movement without crying; and 4 = struggling or disruptive movement with crying. Higher scores indicate more disruptive behavior. The score recorded for each participant will be the highest OSUBRS category observed during the dental procedure. Behavior will be independently rated by 3 trained raters using the standardized video recording of the appointment.
Time frame: During the dental treatment visit, from the start of the restorative treatment of the primary tooth until completion of treatment.
Dental anxiety during treatment assessed with the Venham Clinical Anxiety Rating Scale.
Child dental anxiety during restorative treatment of a primary tooth will be assessed using the Venham Clinical Anxiety Rating Scale (VCARS). This observational scale ranges from 0 to 5: 0 = relaxed, smiling, willing and able to converse; 1 = uneasy or concerned, with brief or quiet protest and possible tears, but able to continue; 2 = scared, with anxious tone or verbal protest, quiet crying, tense or raised hands, but still coping; 3 = pronounced verbal protest or crying and attempts to stop the procedure; 4 = anxiety interfering with coping, generalized crying and prominent body movement, although verbal communication remains possible; and 5 = child out of contact with the situation, with loud crying, inability to listen to verbal communication and escape behavior. Higher scores indicate greater dental anxiety. The score recorded will be the highest level of anxiety observed during the dental procedure. Anxiety will be independently rated by 3 trained raters
Time frame: During the dental treatment visit, from the start of the restorative treatment of the primary tooth until completion of treatment.
Child cooperation during dental treatment assessed with the Frankl Behavior Rating Scale.
Child behavior during restorative of a primary tooth will be assessed using the Frankl Behavior Rating Scale. The scale classifies behavior into four categories: 1 = definitely negative, refusal of treatment, forceful crying, fearfulness or other overt evidence of extreme negativism; 2 = negative, reluctance to accept treatment, uncooperative behavior or withdrawn/sullen attitude; 3 = positive, acceptance of treatment, sometimes with caution or reservation, but following the dentist's directions; and 4 = definitely positive, good rapport with the dentist, interest in the procedure, laughing and enjoyment. Higher scores indicate better cooperation. The score recorded will be the overall Frankl category observed during the dental procedure. Behavior will be independently rated by 3 trained raters using the standardized video recording of the appointment.
Time frame: During the dental treatment visit, from the start of the restorative treatment of the primary tooth until completion of treatment.
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — Individual participant data, including video recordings, will not be shared with other researchers due to the sensitive nature of the data involving minors. The videos contain identifiable images of children undergoing dental treatment, and sharing them would pose significant privacy and confidentiality risks that cannot be fully mitigated through anonymization. In accordance with ethical approval requirements and data protection regulations for research with pediatric populations, access to the video recordings will be restricted to the study investigators only, and no individual-level visual data will be made publicly available or distributed to external researchers.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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