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Completed

NCT Number: NCT06673030

Evaluation of the Effectiveness of New Management Techniques in Reducing Dental Anxiety for Children Undergoing Pulpotomy

The goal of this clinical trial is to reduce dental anxiety for sixety six children undergoing pulpotomy in primary molars by using kaleidoscope glasses and Tell-Show-Play-Doh techniques and evaluation of behavior and anxiety achieved by using FLAAC scale, measuring heart rate and RMS-Pictorial scale.

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Key information

Conditions

Anxiety Anxiety Disorders Mental Disorders

Age range

4 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Mansoura university

Mansoura, Egypt., Egypt

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

1. Children attended the dental clinic for their first time.

  • Children aged between 4 to 6 years including both boys and girls. 3. Healthy Children with Frankl's behavior rating score 2,3 and 4 of Frankl's behavior rating scale and no prior dental experience.
  • Children with carious lesions in lower restorable primary molars and indicated for pulpotomy.
  • Exclusion Criteria: 1.Children with known significant visual impairments or psychological problems.
  • Children suffering from systemic diseases or special health care needs.

Treatment and study plan

Using Kaleidoscope glasses during pulpotomy procedures

Behavioral

Kaleidoscope is an instrument that shows an infinite number of fascinating geometric shapes in the form of a flower, repeating and reflecting images of coloured goggle fragments in the front section in a prism mirroring the inner surface.

The Play-Doh Doctor Drill 'n Fill toy set

Behavioral

Consists of a plastic human head with slots into which Play-doh molded teeth can be inserted. A battery operated toy drill is used to drill into and clean the black, cavitated tooth model and filled with white Play-Doh compound to simulate cavity preparation and restoration using tooth colored cement.

Group 1 (Tell-Show-Do)

Other

In which Tell-Show-Do technique was done in three stages:

  • Tell: The dental procedures were explained to the children using language and expressions appropriate for their age.
  • Show: This began with showing the child the instruments and the topical anesthetic gel, high-speed handpiece and explaining the purpose of using the handpiece. and how the water removed using the suction device.
  • Do: Performing the dental procedure immediately.

Primary outcomes

  1. Assessment of behavior of the child before and during and after the pulpotomy procedures.

    Time frame: Pre-operatively , during the procedure and post-operatively at the end of the visit at the same visit with no follow up.

    • Assessment of behavior of the child using ( Frankl's behavior rating scale to measure the cooperation behavior of the child, FLACC scale ).
    • Frankl's behavior rating scale was used pre-operatively and post-operatively with 4 scores : score 1(Definitely negative) score 2(Negative) score 3(Positive) score 4 (Definitely positive), the best scores for positive attitude and cooperation are score 3, 4.
    • The FLACC scale was used to measure behavior of the child according to Face, Legs, Activity, Cry and Consolability during the pulpotomy procedures with Scores: (0 = Relaxed and comfortable) (1-3 = Mild discomfort ) (4-6 = Moderate pain) (7-10 = Severe discomfort/pain).

  2. Assessment of anxiety of the child before and after the pulpotomy procedures.

    Time frame: Pre-operatively and post-operatively at the end of the visit at the same visit with no follow up.

    • Assessment of anxiety of the child using (Pulse Oximeter to measure heart rate pre-operatively and post-operatively, RMS Pictorial Scale at the end of the visit). Increasing in heart rate readings means increasing anxiety.
    • RMS Pictorial Scale which comprises a row of five faces ranging from score 1(very happy) to score 5 (very unhappy) and the children were asked to choose the face they felt like about themselves at that moment.

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

Evaluation of the Effectiveness of Kaleidoscope and Tell-Show-Play-Doh in Reducing Dental Anxiety for Children Undergoing Pulpotomy in Primary Molars - a Randomized Controlled Clinical Trial

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 4, 2024
Registry last updated
Nov 4, 2024

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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