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

Not Applicable

Completed

• Conditions: Clinical Anxiety; Clinical Cooperation
• Interventions: Behavioral: cognitive-behavioral therapy; Drug: Nitrous Oxide-Oxygen conscious sedation

• Registration Number: NCT02024594
• Lead Sponsor: Mashhad University of Medical Sciences

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Primary Completion: 2010-07
• Status Verified: 2013-12
• Study First Submitted: 2013-12-27
• Study First Submitted QC: 2013-12-27
• Last Update Submitted: 2013-12-27
• Study First Posted: 2013-12-31
• Last Update Posted: 2013-12-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

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Exclusion Criteria

• current episodes of medications or drug therapy
• systemic or congenital disorders
• mental retardation

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cognitive-behavioral therapy	cognitive-behavioral therapy	Children in this group were asked to come to playroom before entering operation room. Modeling , Benson relaxation and positive self-talking were instructed to them.
Nitrous Oxide-Oxygen	Nitrous Oxide-Oxygen conscious sedation	Children in this group were sedated by rapid induction method by means of Nitrous Oxide-Oxygen gas.

Primary Outcome Measures

Name	Time	Method
change from baseline in Clinical Anxiety and Cooperation scales.	baseline and 1 week	The anxiety and cooperation differences between the two dental visits (second visits were done after 1 week) were compared within the three groups.