Efficacy of Camouflaged Syringe vs Conventional Syringe (ECC)

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

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.

Study Overview

• Status: Completed
• Conditions: Dental Anxiety; Behavior
• Intervention / Treatment: Device: Conventional Syringe; Device: Camouflage 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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Maharashtra
    • Parbhani, Maharashtra, India, 431401
      • Dr Sneha D Suwarnkar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sneha D. Suwarnkar
• Investigators: Principal Investigator: Sneha D Suwarnkar, MDS, Saraswati Dhanwantari Dental College and Hospital, Parbhani

Study record dates

Study Major Dates

• Study Start (Actual): August 13, 2017
• Primary Completion (Actual): August 27, 2017
• Study Completion (Actual): August 30, 2017

Study Registration Dates

• First Submitted: May 30, 2018
• First Submitted That Met QC Criteria: June 11, 2018
• First Posted (Actual): June 25, 2018

Study Record Updates

• Last Update Posted (Actual): October 5, 2018
• Last Update Submitted That Met QC Criteria: October 3, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Anxiety; Camouflaged syringe; Conventional syringe
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: SaraswatiDhanwantari

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: it will be dependent on publication

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No