NCT Number: NCT02024594
Comparison of Effect of Nitrous Oxide-Oxygen Conscious Sedation and Cognitive-behavioral Therapy on Children's Anxiety in Dentistry
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.
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Notify MeKey information
Conditions
Age range
36 month–78 month
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Cognitive-Behavioral Therapy
BehavioralPrimary outcomes
-
change from baseline in Clinical Anxiety and Cooperation scales.
Time frame: 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.
Sponsors and collaborators
Lead sponsor
Mashhad University of Medical Sciences
Other
Registry information
Important dates
- Study start
- 2009
- Primary completion
- 2010
- First posted
- Dec 31, 2013
- Registry last updated
- Dec 31, 2013
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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