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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03566212
Other study ID # SaraswatiDhanwantari
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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