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Clinical Trials/ISRCTN57204958
ISRCTN57204958
Completed
N/A

Physiological changes of children with special needs in the application of a papoose board during dental treatment and their caregiver's acceptance: a non-blinded randomized crossover trial

niversiti Teknologi MARA0 sites88 target enrollmentAugust 27, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Children with special needs while receiving dental treatment
Sponsor
niversiti Teknologi MARA
Enrollment
88
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36291461/ (added 19/12/2022)

Registry
who.int
Start Date
August 27, 2020
End Date
June 9, 2022
Last Updated
3 years ago
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • 1\. All children with special needs aged 16 years old and below who are willing to sit in the dental chair without excessive physical persuasion
  • 2\. Children with special needs who will be subjected to either prophylaxis treatment (using a bristle brush with a slow speed handpiece) or simple composite restorative treatment (class I) (using a round burr with a slow handpiece for anterior/posterior teeth)
  • 3\. No previous history of Papoose board experience
  • 4\. No previous trauma to the fingers of the hand (to enable electrode use in that hand)
  • Caregiver can read and understand the language of conduct (Bahasa Malaysia/English)

Exclusion Criteria

  • 1\. Medically compromised child with any kind of underlying heart disease that may affect the heart rate variability measurement
  • 2\. Child who requires any prophylaxis or restorative treatment in conjunction with the usage of local anaesthesia or inhalation sedation
  • 3\. Child who are taken any medication or caffeinated drink on the day of the treatment/intervention
  • 4\. Child with episode of asthma and seizure attack, or restrictions in circulation over the past 3 months
  • 1\. Caregiver cannot read and understand the language of conduct (Bahasa Malaysia/English)
  • 2\. Caregiver refuses to give consent for their child and themselves to participate in this study

Outcomes

Primary Outcomes

Not specified

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