Efficacy of Camouflaged Syringe vs Conventional Syringe

NCT03566212 | Completed DMC

• 1 other identifier: SaraswatiDhanwantari
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Anxiety; Behavior

Keywords

Anxiety; Camouflaged syringe; Conventional syringe

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Behavior rating by using Frankel Behaviour rating scale

  after 10 minutes

Study Arms (2)

conventional syringe

EXPERIMENTAL

Individuals requiring local anesthesia for dental treatment were treated in first group by using conventional syringe.

Device: Conventional Syringe

camouflaged syringe

EXPERIMENTAL

Individuals requiring local anesthesia for dental treatment were treated in second group by using camouflage syringe.

Device: Camouflage Syringe

Interventions

Conventional Syringe DEVICE

local anesthesia was administered in first group using Conventional syringe

conventional syringe

Camouflage Syringe DEVICE

local anesthesia was administered in second group using Camouflage syringe

camouflaged syringe

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• retained teeth,
• badly carious teeth,
• mobile teeth
• requiring a dental procedure under local anesthesia were selected.

You may not qualify if:

• Mentally challenged children
• those with medical conditions contraindicating the use of local anesthesia and / or surgical procedures

Sponsors & Collaborators

• Sneha D. Suwarnkar: lead

Study Sites (1)

Dr Sneha D Suwarnkar

Parbhani, Maharashtra, 431401, India

Location

MeSH Terms

Conditions

Behavior; Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Sneha D Suwarnkar, MDS

  Saraswati Dhanwantari Dental College and Hospital, Parbhani

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Model Details: local anesthesia is administered by using either camouflaged syringe or conventional syringe and was compared for reduction in anxiety levels in both groups

Study Record Dates

• First Submitted: May 30, 2018
• First Posted: June 25, 2018
• Study Start: August 13, 2017
• Primary Completion: August 27, 2017
• Study Completion: August 30, 2017
• Last Updated: October 5, 2018

Record last verified: 2018-10

Locations

IN (1)