Comparison of Effect of Nitrous Oxide-Oxygen Conscious Sedation and Cognitive-behavioral Therapy on Children's Anxiety in Dentistry
1 other identifier
interventional
45
0 countries
N/A
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.
Trial Health
Trial Health Score
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participants targeted
Target at P25-P50 for not_applicable
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedFirst Submitted
Initial submission to the registry
December 27, 2013
CompletedFirst Posted
Study publicly available on registry
December 31, 2013
CompletedDecember 31, 2013
December 1, 2013
9 months
December 27, 2013
December 27, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (3)
Nitrous Oxide-Oxygen
EXPERIMENTALChildren in this group were sedated by rapid induction method by means of Nitrous Oxide-Oxygen gas.
cognitive-behavioral therapy
EXPERIMENTALChildren in this group were asked to come to playroom before entering operation room. Modeling , Benson relaxation and positive self-talking were instructed to them.
control
NO INTERVENTIONNo intervention
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- current episodes of medications or drug therapy
- systemic or congenital disorders
- mental retardation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principle investigator
Study Record Dates
First Submitted
December 27, 2013
First Posted
December 31, 2013
Study Start
October 1, 2009
Primary Completion
July 1, 2010
Last Updated
December 31, 2013
Record last verified: 2013-12