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OpenTrials
Completed

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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Key information

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

Nitrous Oxide-Oxygen conscious sedation

Drug

Cognitive-Behavioral Therapy

Behavioral

Primary outcomes

  1. 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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