Efficacy of Camouflaged Syringe vs Conventional Syringe

Behavior Clinical Trial

— ECC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03566212
• Other study ID #: SaraswatiDhanwantari
• Status: Completed
• Phase: N/A
• Start date: August 13, 2017
• Est. completion date: August 30, 2017

Study information

• Verified date: October 2018
• Source: Saraswati-Dhanwantari Dental College & Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 30, 2017
• Est. primary completion date: August 27, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Behavior
• Dental Anxiety

Intervention

Device:
• Conventional Syringe
local anesthesia was administered in first group using Conventional syringe
• Camouflage Syringe
local anesthesia was administered in second group using Camouflage syringe

Locations

Country	Name	City	State
India	Dr Sneha D Suwarnkar	Parbhani	Maharashtra

Sponsors (1)

Lead Sponsor	Collaborator
Sneha D. Suwarnkar

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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