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The goal of this clinical trial is to investigate if Kaleidoscope glasses help children feel less pain and worry during dental work. It will also explore if these glasses help children feel more comfortable with the dentist.
Kaleidoscope glasses are special glasses show bright, colorful shapes. The patterns change every time the child moves their head. This helps keep the child's mind off the dental work.
The main questions it aims to answer are:
Do the glasses lower a child's pain during a numbing shot and tooth treatment?
Do the glasses help a child feel less anxious during the visit?
Researchers will compare the glasses to a method called "Tell-Show-Do" to see which works best. "Tell-Show-Do" is when a dentist explains and shows tools before using them.
Participants will:
Get a nerve treatment (a "baby root canal") on a bottom baby tooth.
Wear the Kaleidoscope glasses, have the researcher use "Tell-Show-Do," or do both.
Have their pulse and pain levels checked before, during, and after the visit.
To keep the study fair, the child will be put into 1 of 3 groups by picking a sealed random envelope.
The groups are:
Group 1: The child wears Kaleidoscope glasses (the special glasses).
Group 2: The child wears Kaleidoscope glasses and the operator uses the "Tell-Show-Do" method during the visit with the child.
Group 3: The operator uses the "Tell-Show-Do" method during the visit with the child only.
This study helps make the dental visit easier and more comfortable for children. It aims to:
Lower pain during the tooth treatment. Help children feel less afraid of the dentist. Make children more willing to get the care they need. The research also helps dentists give better care by building trust with their young participants.
Risks:
There are no serious risks in this study. In rare cases, a child may not want to wear the special glasses. If this happens, the researcher will stop using the glasses but will still finish the tooth treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Behavior management using the Tell-Show-Do technique during the treatment. | Active Comparator | Behavior management using the Tell-Show-Do technique during the treatment. |
|
| behavior management using Kaleidoscope glasses. | Experimental | behavior management while the child is wearing Kaleidoscope glasses (SOL, country of origin: China) during the treatment. |
|
| behavior management using the Tell-Show-Do technique and Kaleidoscope glasses | Experimental | behavior management using the Tell-Show-Do technique and while the child is wearing Kaleidoscope glasses (SOL, country of origin: China). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| behavior management using Kaleidoscope glasses (SOL, country of origin: China). | Behavioral | behavior management using Kaleidoscope glasses (SOL, country of origin: China). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of pain using the Face, Legs, Activity, Cry, Consolability (FLACC) scale | Assessment of pain using the FLACC scale: (Quantitative outcome) 0-10 score with 0 representing no pain and better outcome and data will be collected directly from participants. | Child's pain level will be assessed during Local anesthesia injection and pulpotomy by using the FLACC scale. |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of dental anxiety | Assessment of dental anxiety using finger Pulse oximeter (Quantitative outcome) scores(beats/min) | Child's anxiety level will be collected using a Pulse oximeter before behaviour management, pre-operatively after behaviour management, and within 5 minutes postoperatively. |
| Assessment of dental anxiety using Facial Image Scale (FIS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nada M. Abdelaziz, Bachelor degree | Contact | +201005171751 | nada.mosaad@dentistry.cu.edu.eg |
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|
| behavior management using the Tell-Show-Do technique and Kaleidoscope glasses (SOL, country of origin: China). | Behavioral | behavior management using the Tell-Show-Do technique and Kaleidoscope glasses (SOL, country of origin: China). |
|
|
| behavior management using the Tell-Show-Do technique. | Behavioral | behavior management using the Tell-Show-Do technique. |
|
|
Assessment of dental anxiety using Facial Image Scale (FIS): (Quantitative outcome) Image scores (1-5) with 1 (most positive child experience and best outcome) and 5 (most negative and worst outcome). |
| Child's anxiety level will be collected using a facial image scale before behaviour management, pre-operatively after behaviour management, and within 5 minutes postoperatively. |
| ID | Term |
|---|---|
| D014098 | Toothache |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D005157 | Facial Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D019904 | Polymethyl Methacrylate |
| ID | Term |
|---|---|
| D008768 | Methylmethacrylates |
| D011109 | Polymethacrylic Acids |
| D000179 | Acrylates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000180 | Acrylic Resins |
| D012117 | Resins, Synthetic |
| D010969 | Plastics |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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