- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04262063
Effectiveness of TPD Tech VS TSD Tech
Effectiveness of Tell Play do Technique in Comparison to Tell Show do Technique for the Management of Anxious Children: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Child dental anxiety has been a matter of concern for many years. It is defined as a nonspecific feeling of apprehension, worry, uneasiness and the source may be not clear or unknown .
Dental anxiety is considered as a major obstacle for the dental treatment. The dental appointment is a stressful situation specially for children which raises their anxiety level. Different studies among 6-12 years old children showed that 20%- 43 % exhibited high dental fear and anxiety .
Dental fear and anxiety can have negative implications for children's oral health. There is certainty for the negative impact of dental anxiety on the oral health-related quality of life of children, and studies have shown that children with dental fear and anxiety have worse oral health status than their peers (more untreated carious lesions).
It is also children with dental fear and anxiety may present with behavioral management problems which can disrupt the provision of dental treatment and negatively impact on the dental treatment the child receives. The anxiety experienced by children is not only distressing for the child, but it can also be a potentially stressful and upsetting experience for their parents .
A good patient-dentist relationship is crucial for the management of anxiety. It is the responsibility of pedodontists to make dentistry as child-friendly and pain-free as possible to bring about positive changes in the behavior of children during dental treatment .
Tell-show-do technique is widely used for managing pediatric dental patients. It is useful for almost all patients who can communicate, especially those patients who are 'monitors. Although widely used, the ability of this technique to prepare, and reduce child anxiety remains an area for research, because it's not always appropriate for those patients who are 'blunters' where detailed information can result in increased levels of anxiety .
So different modifications of this technique were used one of them is tell play do technique with a dental imitation toy and using euphemisms instead of demonstrating on a model or observing one. Tell play do technique provides a better explanatory concept of the dental procedure and can lead to more cooperation of the children patients which can influence the dental treatment in a good and positive way.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: rehab mohammed, master
- Phone Number: 01152349678
- Email: rehab.ebrahim@dentistry.cu.edu.eg
Study Contact Backup
- Name: sara mahmoud, phd
- Phone Number: 01000042564
- Email: sara_yn79@yahoo.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Children with Frankl's behavior rating score of 1,2 .
- Patients with no previous dental experience.
- Patients not suffering from cognitive or mental problems.
- Children with primary molars indicated for extraction .
- Age 4- 6 years old .
Exclusion Criteria:
- Medically compromised patients
- Patients suffering from cognitive or mental problems
- Patients with previous dental experience
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: tell play do technique
Tell play do technique with a dental imitation toy and using euphemisms instead of demonstrating on a model or observing one.
Tell play do technique provides a better explanatory concept of the dental procedure and can lead to more cooperation of the children patients which can influence the dental treatment in a good and positive way.
|
it apply the concept of learning by doing .children
will enjoy playing with customized dental models
|
Active Comparator: tell show do technique
Tell show do is the gold standard of the non-pharmacological behavior management techniques.
It is based on the principle of learning theory and it is performed by the dentists themselves .
It is the most important behavior modification technique practiced by dentists and it is commonly used for management of children anxiety in the first dental visit .
|
Tell: your dentist explaining to you what they'd like to do Show: showing you what is involved (e. g. showing the equipment and demonstrating it on a finger) Do: performing the procedure
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
level of anxiety
Time Frame: Immediate In the first visit
|
The level of dental anxiety of each patient will be assessed using finger pulse oximeter.
|
Immediate In the first visit
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change in behavior
Time Frame: immediate after the behavior management
|
the operator will grade the child's behavior during the procedure using the (Face, Leg, Activity, Cry, Consolability) behavioral pain assessment scale.(FLACC) each category scores from 0-2 scale which result in a total score of 0-10 0 relaxed and comfortable 1-3 mild discomfort 4-6 moderate pain 7-10 severe discomfort of pain or both |
immediate after the behavior management
|
Ease of handling patients
Time Frame: immediate the end of the treatment
|
The ease of handling the patient will be assessed using a validated questionnaire by 5-point Likert scale (1- Strong positive , 2- Positive, 3- Neutral , 4- Negative,5- Strong negative)
|
immediate the end of the treatment
|
Ease of doing the procedures
Time Frame: immediate at the end of the treatment
|
the ease of doing the procedures will be assessed using a validated questionnaire by 5-point Likert scale (1- Strong positive , 2- Positive, 3- Neutral , 4- Negative, 5- Strong negative)
|
immediate at the end of the treatment
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- eff of TPD vsTSD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Dental Anxiety
-
University of PaviaEnrolling by invitationDental Anxiety | Dental PhobiaItaly
-
Cairo UniversityUnknownAnxiety, Dental | Fear, Dental
-
St. Justine's HospitalRecruitingDental Anxiety | Dental Trauma | Dental Diseases | Dental PhobiaCanada
-
St. Justine's HospitalRecruitingDental Anxiety | Dental Trauma | Dental Diseases | Dental PhobiaCanada
-
National Taiwan University HospitalUnknownDental Anxiety | Dental Trauma | Dental DiseasesTaiwan
-
King Abdulaziz UniversityCompletedDental Anxiety | Dental FearSaudi Arabia
-
Cairo UniversityNot yet recruiting
-
Aisha Mohammed Hamziclinical professorNot yet recruiting
-
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityNot yet recruiting
-
Burdur Mehmet Akif Ersoy UniversityCompleted
Clinical Trials on Tell play do technique
-
Hams Hamed AbdelrahmanCompleted
-
Alejandra Ramírez CarrascoUnknownPain | Dental Anxiety
-
Isparta University of Applied SciencesAkdeniz UniversityRecruitingChild | Anxiety | Parents | Preoperative CareTurkey
-
Nourhan M.AlyAlexandria UniversityCompleted
-
King Abdulaziz UniversityCompletedBehavioral Guidance in Pediatric DentistrySaudi Arabia
-
Hams Hamed AbdelrahmanRecruiting
-
Mansoura UniversityActive, not recruiting
-
Istanbul UniversityIstanbul Technical UniversityCompleted
-
Mansoura UniversityActive, not recruiting
-
Zahedan University of Medical SciencesCompletedDental Anxiety | Cooperative BehaviourIran, Islamic Republic of