ChildNCT07880626
Child Behavior Ratings During Dental Treatment
An observational study of Child and Behaviour, run by University of Valencia at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 4 to 10 years
- What is being tested?
- Video recording
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 20 Oct 2026to 30 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 4 to 10 years
- All sexes
- No healthy volunteers
- Child
Study population: 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.
Who may be able to join
- Children aged 4 to 10 years
- ASA physical status I or II
- Children requiring restorative treatment for dental caries under local anesthesia
- Children attending the participating university dental clinic.
Who cannot join
- Children with neurological or cognitive disorders
- Children whose parents or legal guardians do not agree to their participation in the study or do not sign the informed consent forms for dental treatment, the use of images, and participation in the study
- Clinical situations in which video recording may interfere with the safety of the procedure or compromise the patient's well-being
- Video recording of insufficient quality to permit behavioral assessment.
- Withdrawal of consent before completion of study procedures.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Dentistry Clinic. Medicine and Dentistry school. Valencia University
Valencia, Valencia, 46010
Angeles Velló Ribes, 600457610, angelesvello@yahoo.es
About this study
Official title: Inter-rater Agreement of Four Child Behavior Rating Scales During Dental Treatment Based on Clinical Video Recordings
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.
Read more
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.
- Being tested
- Video recording
- Keywords
- Child, Dental, Behaviour, Scale
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video recordingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| • Children requiring restorative treatment for dental caries under local anesthesia | • Children requiring restorative treatment for dental caries under local anesthesia Receives: Behavioral: Video recording |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: During the dental treatment visit, from the start of the restorative treatment of the primary tooth until completion of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study start20 Oct 2026 (estimated)
- Primary completion30 Mar 2027 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ChildStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, María Ángeles Velló Ribes, University of Valencia
- Investigators
- Montserrat Catala Pizarro, Study chair, UNIVERSITAT DE VALENCIA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07880626
- Sponsor's protocol ID
- 2026-ODON-4511724
- Status last verified
- Oct 2026
- First submitted
- 30 Sep 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Sado-Filho J, Viana KA, Correa-Faria P, Costa LR, Costa PS. Randomized clinical trial on the efficacy of intranasal or oral ketamine-midazolam combinations compared to oral midazolam for outpatient pediatric sedation. PLoS One. 2019 Mar 11;14(3):e0213074. doi: 10.1371/journal.pone.0213074. eCollection 2019.
PubMed 30856181Shindova MP, Belcheva AB. Behaviour Evaluation Scales For Pediatric Dental Patients - Review And Clinical Experience. Folia Med (Plovdiv). 2014 Oct-Dec;56(4):264-70. doi: 10.1515/folmed-2015-0006.
PubMed 26444356Wilson S, Molina Lde L, Preisch J, Weaver J. The effect of electronic dental anesthesia on behavior during local anesthetic injection in the young, sedated dental patient. Pediatr Dent. 1999 Jan-Feb;21(1):12-7.
PubMed 10029962Hammadyeh AR, Altinawi MK, Rostom F. Comparison of two intravenous sedation techniques for use in pediatric dentistry: A randomized controlled trial. Dent Med Probl. 2019 Oct-Dec;56(4):337-341. doi: 10.17219/dmp/109929.
PubMed 31596061Garret-Bernardin A, Festa P, Matarazzo G, Vinereanu A, Aristei F, Gentile T, Piga S, Bendinelli E, Cagetti MG, Galeotti A. Behavioral Modifications in Children after Repeated Sedation with Nitrous Oxide for Dental Treatment: A Retrospective Study. Int J Environ Res Public Health. 2023 Feb 24;20(5):4037. doi: 10.3390/ijerph20054037.
PubMed 36901046
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inter-rater Agreement of Four Child Behavior Rating Scales During Dental Treatment Based on Clinical Video Recordings
- ClinicalTrials.gov ID
- NCT07880626
- Acronym / sponsor ID
- 2026-ODON-4511724
- Keywords
- Child, Dental, Behaviour, Scale
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 20 Oct 2026 (estimated)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 19 Oct 2026 (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 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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| • Children requiring restorative treatment for dental caries under local anesthesia | – | Behavioral: Video recording• Children requiring restorative treatment for dental caries under local anesthesia |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 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.
Key inclusion criteria (4 listed)
- Children aged 4 to 10 years
- ASA physical status I or II
- Children requiring restorative treatment for dental caries under local anesthesia
- Children attending the participating university dental clinic.
Key exclusion criteria (5 listed)
- Children with neurological or cognitive disorders
- Children whose parents or legal guardians do not agree to their participation in the study or do not sign the informed consent forms for dental treatment, the use of images, and participation in the study
- Clinical situations in which video recording may interfere with the safety of the procedure or compromise the patient's well-being
- Video recording of insufficient quality to permit behavioral assessment.
- Withdrawal of consent before completion of study procedures.
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 |
|---|---|---|
| Video recordingVideo 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. | Behavioural | • Children requiring restorative treatment for dental caries under local anesthesia |
Primary outcome
Overall behavior during dental treatment assessed with the Houpt Behavior Rating Scale.
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 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.
Child behavior during dental treatment assessed with the Ohio State University Behavioral Rating Scale (OSUBRS).
Time frame: During the dental treatment visit, from the start of the restorative treatment of the primary tooth until completion of treatment.
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.
Dental anxiety during treatment assessed with the Venham Clinical Anxiety Rating Scale.
Time frame: During the dental treatment visit, from the start of the restorative treatment of the primary tooth until completion of treatment.
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
Child cooperation during dental treatment assessed with the Frankl Behavior Rating Scale.
Time frame: During the dental treatment visit, from the start of the restorative treatment of the primary tooth until completion of treatment.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Background: PubMed 30856181Sado-Filho J, Viana KA, Correa-Faria P, Costa LR, Costa PS. Randomized clinical trial on the efficacy of intranasal or oral ketamine-midazolam combinations compared to oral midazolam for outpatient pediatric sedation. PLoS One. 2019 Mar 11;14(3):e0213074. doi: 10.1371/journal.pone.0213074. eCollection 2019.
- Background: PubMed 26444356Shindova MP, Belcheva AB. Behaviour Evaluation Scales For Pediatric Dental Patients - Review And Clinical Experience. Folia Med (Plovdiv). 2014 Oct-Dec;56(4):264-70. doi: 10.1515/folmed-2015-0006.
- Background: PubMed 10029962Wilson S, Molina Lde L, Preisch J, Weaver J. The effect of electronic dental anesthesia on behavior during local anesthetic injection in the young, sedated dental patient. Pediatr Dent. 1999 Jan-Feb;21(1):12-7.
- Background: PubMed 31596061Hammadyeh AR, Altinawi MK, Rostom F. Comparison of two intravenous sedation techniques for use in pediatric dentistry: A randomized controlled trial. Dent Med Probl. 2019 Oct-Dec;56(4):337-341. doi: 10.17219/dmp/109929.
- Background: PubMed 36901046Garret-Bernardin A, Festa P, Matarazzo G, Vinereanu A, Aristei F, Gentile T, Piga S, Bendinelli E, Cagetti MG, Galeotti A. Behavioral Modifications in Children after Repeated Sedation with Nitrous Oxide for Dental Treatment: A Retrospective Study. Int J Environ Res Public Health. 2023 Feb 24;20(5):4037. doi: 10.3390/ijerph20054037.
- Individual participant dataSharing planned: 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.
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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.
Montserrat Catala Pizarro study chair
UNIVERSITAT DE VALENCIA
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 Child and Behaviour, run by University of Valencia at 1 site in Spain.
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 4 inclusion and 5 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: opening soon, as of the sponsor's last update on 21 Oct 2026. 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 Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact María Angeles Velló Ribes, Assistant Professor (PhD) (+34600457610, m.angeles.vello@uv.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall behavior during dental treatment assessed with the Houpt Behavior Rating Scale. (time frame: During the dental treatment visit, from the start of the dental procedure until completion of treatment of the primary tooth.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07880626, which also lists 5 linked publications.
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 21 Oct 2026.