Clinical trial NCT06912789: Technological Contributions to Behavior Guidance Techniques
Official title: Are Technological Contributions in Behavior Guidance Techniques Superior to Conventional Methods? : Effects on Dental Anxiety and Pain Perception in Pulpotomy Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Behavior
Child
Dental Anxiety
Mobile Applications
Pain
Lead sponsor: Recep Tayyip Erdogan University Training and Research Hospital
Sponsor class: OTHER
First posted: 2025-04-06
Enrollment: 63
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Pediatric population

Brief summary: This study aims to evaluate the effects of three different behavior guidance methods on children's dental anxiety and pain perception.

Detailed description: This study will include 63 children aged 6-8 years who will require pulpotomy followed by a Class II composite restoration and will be divided into three groups: tell-show-do (TSD; Group 1), TSD with video modeling (Group 2), and TSD with a mobile phone application (Group 3). Systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR), and hemoglobin oxygen saturation (SPO2) of the participants will be recorded before the procedure, after local anesthesia, after pulpotomy, and at the end of the procedure. Faces Version of the Modified Child Dental Anxiety Scale (MCDAS f), Wong-Baker Faces Pain Rating Scale (WBFPRS), and Face, Legs, Activity, Cry, Consolability (FLACC) pain scales will be applied.

Eligibility criteria: Inclusion Criteria:

* the patients had no previous dental treatment,
* were between ages 6 and 8 years, accepted treatment accompanied by parents,
* scored 3 (positive) or 4 (definitely positive) on the Frankl behavior scale,
* had no systemic disease,
* did not need emergency dental treatment, one of the upper molars required pulpotomy followed by a Class II composite restoration,
* had no mental or physical disabilities,
* understood the commands, and whose parents agreed to participate in the study
* signed the consent form.

Exclusion Criteria:

* Patients who did not meet the inclusion criteria included those who needed other asymptomatic root canal treatment other than pulpotomy indication,
* needed restorative treatment due to a history of dental trauma, those who did not want to be included voluntarily,
* who cried during the procedure or left the treatment unfinished,
* who were determined to be negative (2) or definitely negative (1) according to the Frankl behavior assessment scale.

Primary outcomes:
measure: The primary outcomes of this study will be assessed through physiological measurements ( Blood Pressure)
timeFrame: 3 months
measure: The primary outcomes of this study will be assessed through physiological measurements (Heart rate)
timeFrame: 3 months
measure: The primary outcomes of this study will be assessed through physiological measurements (hemoglobin oxygen saturation)
timeFrame: 3 months
measure: The primary outcomes of this study will be assessed through psychometric measurements (The Faces Version of the Modified Child Dental Anxiety Scale)
timeFrame: 3 months
measure: The primary outcomes of this study will be assessed through evaluation of dental pain perception (The Wong-Baker Faces Pain Rating Scale)
timeFrame: 3 months
measure: The primary outcomes of this study will be assessed through evaluation of dental pain perception (Face, Legs, Activity, Cry, Consolability)
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rize
country: Turkey
facility: Recep Tayyip Erdoğan University Faculty of Dentistry
Study officials:
affiliation: Recep Tayyip Erdogan University Faculty of Dentistry
name: Dilara Nil Günaçar, Assoc. Prof.
role: STUDY_CHAIR
References: