Comparison of Effect of Nitrous Oxide-Oxygen Conscious Sedation and Cognitive-behavioral Therapy on Children's Anxiety in Dentistry

Clinical Anxiety Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02024594
• Other study ID #: 88311
• Status: Completed
• Phase: N/A
• First received: December 27, 2013
• Last updated: December 27, 2013
• Start date: October 2009

Study information

• Verified date: December 2013
• Source: Mashhad University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Visiting anxious and fearful children is an inevitable prospect of the daily work of every dentist who treats pediatric patients. Dentists have been using a wide variety of non-pharmacological and some pharmacologic techniques to assist them in the management of children with anxiety. One strategy which seems promising for pain control in stressful medical situations is teaching the child to use behavioral and cognitive coping skills or a combination of both techniques. An alternative technique to non-pharmacologic approaches in children being anxious and lacking in cooperative ability is sedative technique such as nitrous oxide conscious sedation. As there is lack of studies comparing conscious sedation and combinations of cognitive-behavioral strategies in eliminating children's uncooperative behaviors and dental anxiety, the aim of this study was to compare the effectiveness of inhalation sedation with Nitrous Oxide-Oxygen conscious sedation and cognitive-behavioral therapy to reduce dental anxiety in preschool children.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. primary completion date: July 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 36 Months to 78 Months

Eligibility

Inclusion Criteria:

• Age between3 to 6.5 year of old

• Presence of moderate to severe dental anxiety

• Parents' acceptance to cooperate in sampling process and 2 sessions of dental treatment

• Presence of at least one mandibular primary molar needed pulp treatment

• positive dental history

Exclusion Criteria:

• current episodes of medications or drug therapy

• systemic or congenital disorders

• mental retardation

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Clinical Anxiety
• Clinical Cooperation

Intervention

Drug:
• Nitrous Oxide-Oxygen conscious sedation

Behavioral:
• cognitive-behavioral therapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mashhad University of Medical Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change from baseline in Clinical Anxiety and Cooperation scales.	The anxiety and cooperation differences between the two dental visits (second visits were done after 1 week) were compared within the three groups.	baseline and 1 week	No