Efficacy of Camouflaged Syringe vs Conventional Syringe (ECC)
Primary Purpose
Dental Anxiety, Behavior
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Conventional Syringe
Camouflage Syringe
Sponsored by
About this trial
This is an interventional treatment trial for Dental Anxiety focused on measuring Anxiety, Camouflaged syringe, Conventional syringe
Eligibility Criteria
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
Sites / Locations
- Dr Sneha D Suwarnkar
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
conventional syringe
camouflaged syringe
Arm Description
Individuals requiring local anesthesia for dental treatment were treated in first group by using conventional syringe.
Individuals requiring local anesthesia for dental treatment were treated in second group by using camouflage syringe.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03566212
Brief Title
Efficacy of Camouflaged Syringe vs Conventional Syringe
Acronym
ECC
Official Title
Clinical Comparative Study of Efficacy of Camouflaged Syringe vs Conventional Syringe in Reducing Dental Anxiety
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
August 13, 2017 (Actual)
Primary Completion Date
August 27, 2017 (Actual)
Study Completion Date
August 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sneha D. Suwarnkar
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Anxiety, Behavior
Keywords
Anxiety, Camouflaged syringe, Conventional syringe
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
conventional syringe
Arm Type
Experimental
Arm Description
Individuals requiring local anesthesia for dental treatment were treated in first group by using conventional syringe.
Arm Title
camouflaged syringe
Arm Type
Experimental
Arm Description
Individuals requiring local anesthesia for dental treatment were treated in second group by using camouflage syringe.
Intervention Type
Device
Intervention Name(s)
Conventional Syringe
Intervention Description
local anesthesia was administered in first group using Conventional syringe
Intervention Type
Device
Intervention Name(s)
Camouflage Syringe
Intervention Description
local anesthesia was administered in second group using Camouflage syringe
Primary Outcome Measure Information:
Title
Anxiety levels by using the Chotta Bheem and Chutki scale
Description
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.
Time Frame
after 5 minutes
Secondary Outcome Measure Information:
Title
Behavior rating by using Frankel Behaviour rating scale
Description
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.
Time Frame
after 10 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sneha D Suwarnkar, MDS
Organizational Affiliation
Saraswati Dhanwantari Dental College and Hospital, Parbhani
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr Sneha D Suwarnkar
City
Parbhani
State/Province
Maharashtra
ZIP/Postal Code
431401
Country
India
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
it will be dependent on publication
Learn more about this trial
Efficacy of Camouflaged Syringe vs Conventional Syringe
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