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

NCT ID: NCT06673030

Last Updated: 2024-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-05

Study Completion Date

2024-09-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anxiety

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group 1 (Tell-Show-Do)

Group Type ACTIVE_COMPARATOR

Group 1 (Tell-Show-Do)

Intervention Type 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.

Group 2 ( Tell-Show-Play-Doh)

Group Type EXPERIMENTAL

The Play-Doh Doctor Drill 'n Fill toy set

Intervention Type 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 3 (Kaleidoscope glasses )

Group Type EXPERIMENTAL

Using Kaleidoscope glasses during pulpotomy procedures

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Using Kaleidoscope glasses during pulpotomy procedures

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.

Intervention Type BEHAVIORAL

The Play-Doh Doctor Drill 'n Fill toy set

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.

Intervention Type BEHAVIORAL

Group 1 (Tell-Show-Do)

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

2\. 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.

4\. Children with carious lesions in lower restorable primary molars and indicated for pulpotomy.

Exclusion Criteria

2\. Children suffering from systemic diseases or special health care needs.
Minimum Eligible Age

4 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Mansoura University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Eman Mohamed Yousef Mohamed Elmansy

Master's degree student, Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Mansoura University

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Faculty of Dentistry, Mansoura university

Mansoura, Egypt., , Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

A01011023PP

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.