Efficacy of Camouflaged Syringe vs Conventional Syringe

Study Overview
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Brief Summary
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This study evaluates the efficacy of Camouflage syringe vs Conventional syringe in reducing Dental Anxiety and increasing behaviour rating.Half of the participants received local anesthesia using camouflaged syringe, while others received using conventional syringe.

Detailed Description
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Dental anxiety and phobia result in avoidance of dental care. Since the injection itself can be painful, pain reduction procedures warrant continued investigation. Camouflage design deals with the visual impact of the needle and syringe though the tactile sensation remains unaltered. In our study, post treatment anxiety levels in camouflaged syringe was reduced as compared to conventional syringe group and this might be because, patients with low anxiety tend to have high pain thresholds.

Official Title
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Clinical Comparative Study of Efficacy of Camouflaged Syringe vs Conventional Syringe in Reducing Dental Anxiety

Conditions
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Dental Anxiety, Behavior

Intervention / Treatment
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* Device: Conventional Syringe
* Device: Camouflage Syringe


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: retained teeth, badly carious teeth, mobile teeth requiring a dental procedure under local anesthesia were selected. Exclusion Criteria: Mentally challenged children those with medical conditions contraindicating the use of local anesthesia and / or surgical procedures

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: local anesthesia is administered by using either camouflaged syringe or conventional syringe and was compared for reduction in anxiety levels in both groups
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: conventional syringe<br>Individuals requiring local anesthesia for dental treatment were treated in first group by using conventional syringe. | Device: Conventional Syringe<br>* local anesthesia was administered in first group using Conventional syringe<br>|
| Experimental: camouflaged syringe<br>Individuals requiring local anesthesia for dental treatment were treated in second group by using camouflage syringe. | Device: Camouflage Syringe<br>* local anesthesia was administered in second group using Camouflage syringe<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety levels by using the Chotta Bheem and Chutki scale | Anxiety levels in both camouflaged group and conventional group in the children were scored before and after the procedure using the Chotta Bheem and Chutki scale. The Chotta Bheem and Chutki (CBC) scale comprises two separate cards: one for boys and the other for girls. The cartoon characters of Chotta Bheem and Chutki were chosen to depict various emotions for boys and girls respectively. Each card consists of a series of six figures depicting sequentially various emotions from 'happy' to 'unhappy and running away' of the cartoon character. Score 1 is happy face, score 2 is sad face, score 3 is crying face, score 4 is angry face, score 5 is shouting and score 6 is running. So, here, score 1 depicts patient is happy whereas as score increases anxiety level also increases which denotes that patient is unhappy. | after 5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Behavior rating by using Frankel Behaviour rating scale | Behavior rating in both camouflaged group and conventional group in the children were scored before and after the procedure using Frankel Behaviour rating scale. Behavior rating scale comprised of scores from definitely negative to definitely positive. 'Double negative'(--) i.e. 'definitely negative' score indicates that patient refuses treatment, 'negative score'(-) indicates that patient is reluctant to accept treatment, there is evidence of negative attitude but not pronounced, ' positive score' (+) indicates that patient accepts treatment though there is cautious with treatment but follows dentist's instructions cooperatively whereas ' definitely positive score' (++) indicates that there is good raport of patient with dentist and accepts the treatment with enjoyment. So, as score increases from definitely negative to definitely positive, behaviour of children also increases. | after 10 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anxiety, Camouflaged syringe, Conventional syringe