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Completed

NCT Number: NCT06912789

Technological Contributions to Behavior Guidance Techniques

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

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Key information

Conditions

Behavior Child Dental Anxiety Mobile Applications Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

6 year–8 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Recep Tayyip Erdoğan University Faculty of Dentistry

Rize, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. The primary outcomes of this study will be assessed through physiological measurements ( Blood Pressure)

    Time frame: 3 months

    Systolic Blood Pressure (SBP) and diastolic blood pressure (DBP) will be recorded at multiple time points during the procedure: before the procedure, after the administration of local anesthesia, after pulpotomy, and at the end of the procedure.

    Each patient will rest for 15 minutes before BP measurement. Measurements will be taken from the right wrist with the child in an upright position using an automatic wrist blood pressure device (Wohler, Türkiye). Systolic (SBP) and diastolic blood pressure (DBP) values in cm of mercury (cmHg) will be recorded.

  2. The primary outcomes of this study will be assessed through physiological measurements (Heart rate)

    Time frame: 3 months

    Heart rate (HR) will be measured while the child is in a seated position using a finger-type portable pulse oximeter (Oncomed, USA) attached to the child's right finger. HR values on the digital monitor will be measured as beats per minute.

  3. The primary outcomes of this study will be assessed through physiological measurements (hemoglobin oxygen saturation)

    Time frame: 3 months

    Hemoglobin oxygen saturation (SPO2) will be measured while the child is in a seated position using a finger-type portable pulse oximeter (Oncomed, USA) attached to the child's right finger. SPO2 values on the digital monitor will be measured as a percentage.

  4. The primary outcomes of this study will be assessed through psychometric measurements (The Faces Version of the Modified Child Dental Anxiety Scale)

    Time frame: 3 months

    The Faces Version of the Modified Child Dental Anxiety Scale (MCDAS f) will be used to measure the level of anxiety experienced by the children throughout the procedure.

    For this scale, there are five possible responses consisting of smiling or sad faces, appropriate for each answer given by the child. A happy face corresponds to 1 point whereas a very sad face corresponds to 5 points.

    After the dental treatment, the children in all three groups will be asked the questions, after which the scores corresponding to the facial expressions will be chosen by the children and will be recorded by the pediatric dentist. The total score will be calculated as a minimum of 8 and a maximum of 40, with high anxiety being associated with an increasing score.

  5. The primary outcomes of this study will be assessed through evaluation of dental pain perception (The Wong-Baker Faces Pain Rating Scale)

    Time frame: 3 months

    The Wong-Baker Faces Pain Rating Scale (WBFPRS) will be utilized to assess the pain intensity as reported by the children during the dental treatment.

    Wong-Baker Faces Pain Rating Scale (WBFPRS) includes six facial expressions ranging from a smiling face to a crying face.

    These expressions were explained to the children who were asked to choose the face that best reflected the level of pain they felt during treatment. A smiling face was 0 points (no pain) whereas a crying face was 10 points (very severe pain).

    After physiological and psychometric measurements are recorded, the pediatric dentist will use the WBFBS score to evaluate the children's pain perception. The scoring will be recorded by the same pediatric dentist.

    With high dental anxiety associated with an increasing score.

  6. The primary outcomes of this study will be assessed through evaluation of dental pain perception (Face, Legs, Activity, Cry, Consolability)

    Time frame: 3 months

    The Face, Legs, Activity, Cry, Consolability (FLACC) pain scale will be applied to evaluate the child's pain and distress based on observable behavior during the procedure.

    The measurement will be made by evaluating five behavioral categories (i.e., face, legs, activity, crying, and consolability). Each parameter will be scored between 0 and 2, and the total score will range between 0 and 10, where 0 will indicate calm and comfortable, 1-3 will represent mild discomfort, 4-6 will indicate moderate pain, and 7-10 will signify severe discomfort or pain, or both. A score closer to 10 will indicate severe pain, whereas 0 will mean no pain.

Sponsors and collaborators

Lead sponsor

Recep Tayyip Erdogan University Training and Research Hospital

Other

Registry information

Official study title

Are Technological Contributions in Behavior Guidance Techniques Superior to Conventional Methods? : Effects on Dental Anxiety and Pain Perception in Pulpotomy Treatment

Acronym: Pediatrics

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 6, 2025
Registry last updated
Apr 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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