Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06411808
Status:
RECRUITING
Last Update Posted:
2024-07-08
First Post:
2024-05-06
Brief Title:
Evaluating Sensory-Adapted Dental Care in Children With Sensory Processing Disorders
Sponsor:
The University of Texas Health Science Center at San Antonio
Organization:
The University of Texas Health Science Center at San Antonio
Study Overview
Official Title:
The Impact of Sensory-Adapted Dental Environment on Anxiety and Behavior in Children With Sensory Processing Disorders A Crossover Randomized Control Trial
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This clinical trial examines the efficacy of a Sensory-Adapted Dental Environment SADE in reducing anxiety and improving behavioral outcomes in children with sensory processing disorders during routine dental visits By modifying the dental setting to accommodate sensory sensitivities-such as using dim lighting noise-canceling headphones and non-threatening dental tools-the study aims to create a more comfortable dental experience for these children This research could potentially inform broader pediatric dentistry practices making dental care more accessible and less distressing for children with sensory sensitivities
Detailed Description:
The study is a crossover randomized controlled trial designed to assess the impact of a Sensory-Adapted Dental Environment SADE on children with sensory processing disorders focusing on both physiological and behavioral responses Participants will undergo two dental cleaning visits one in a standard dental environment and one in a sensory-adapted setting Each visit will be spaced three to four months apart to monitor short-term effects and behaviors The primary outcomes measured will include changes in anxiety levels as assessed by physiological markers eg heart rate and behavioral scales eg modified dental anxiety scale Secondary outcomes will evaluate the overall acceptance of the sensory-adapted environment by children and their caregivers This study seeks to demonstrate that tailored environmental modifications can significantly improve the dental care experience potentially leading to enhanced long-term dental health and reduced care avoidance among children with sensory processing disorders The trial will also gather qualitative feedback from participants and their parents to better understand individual experiences and refine future adaptations in pediatric dental practices
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None