Use of the Camouflage Syringe to Reduce Dental Anxiety and Fear in Children

NCT01398007 | Completed Phase 2 DMC

• 1 other identifier: SUT2503
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Dental fear and anxiety in children constitue a crucial challenge to dental care delivery as well as future behavior related to dental problems in children. A common cause of such anxiety and fear is the procedural intervention that uses needles and syringes since a visual impact due to the needle acts as a deterrent to the child's cooperation during dental procedures. We therefore improvised the syringe such that it will camouflage the needle. We hypothesized that the use of this needle will alleviate the child's anxiety and therefore will demonstrate improved outcomes related to pain, fear and anxiety. This study is a group randomized trial to test the efficacy of the camouflage syringe as compared to the conventional syringe in children.

Conditions

Anxiety; Fear

Outcome Measures

Primary Outcomes (1)

• Venham's clinical rating scale

  Venham's clinical rating scale for movement, crying and overall behavior

  Within 1 hour of procedure

Secondary Outcomes (3)

• Venham's Picture Test

  Within 1 hour of procedure

• Parental Emotional Stress Questionnaire

  Within 1 hour of procedure

• Recall questionnaire

  Within 2 weeks

Study Arms (2)

Conventional syringe

NO INTERVENTION

Conventional syringe

Camouflage syringe

EXPERIMENTAL

The camouflage syringe is divided into three parts: head, body and tail. Head consists of bristles to apply topical anesthesia. The body holds the normally used conventional syringe and presents with a slot to check the aspiration results. The tail hides the conventional syringe loaded with the local anesthetic solution. This syringe is made up of cold-cure acrylic with a colorful toy-like look.

Procedure: Camouflage syringe

Interventions

Camouflage syringe PROCEDURE

Dental anesthesia is administered using the camouflaged syringe.

Camouflage syringe

Eligibility Criteria

• Age: 2 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children reporting to study center with dental problems
• Dental procedure requiring local anesthesia
• Informed consent from the parents

You may not qualify if:

• Mentally challenged children
• Medical problems negating use of local anesthesia and/or surgical intervention

Sponsors & Collaborators

• Government Dental College and Hospital, India: lead
• Lata Medical Research Foundation, Nagpur: collaborator

Study Sites (1)

Government Dental College and Hospital

Nagpur, Maharashtra, 440003, India

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Vinay K Hazarey, MDS

  Government Dental College and Hospital, India

  STUDY CHAIR

• Jyoti Tote, MDS

  Government Dental College and Hospital, India

  STUDY DIRECTOR

• Pushpa V Hazarey, MDS

  Government Dental College and Hospital, India

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Student Dentist

Study Record Dates

• First Submitted: July 18, 2011
• First Posted: July 20, 2011
• Study Start: October 1, 2005
• Primary Completion: April 1, 2006
• Study Completion: April 1, 2006
• Last Updated: March 11, 2015

Record last verified: 2011-07

Locations

IN (1)