None listed
Conditions
Brief summary
This study will compare the effects of an iPad versus eyeglasses in pain and anxiety management during dental treatment in children aged 4 to 9 years. The hypothesis is that an iPad would be more effective than eyeglasses.
Interventions
The clinical investigation will involve a randomized, controlled, split-mouth study of young children receiving local anesthesia for restorative treatment including vital pulp therapy (i.e., pulpotomy). The study will compare pain, behavior, and heart rate measurements from an exposure group (treatment completed with the aid of an iPad) and control group (treatment completed with the aid of AV eyeglasses). We will assigne each of these two treatments to either left or right halves of the primary
The clinical investigation will involve a randomized, controlled, split-mouth study of young children receiving local anesthesia for restorative treatment including vital pulp therapy (i.e., pulpotomy). The study will compare pain, behavior, and heart rate measurements from an exposure group (treatment completed with the aid of an iPad) and control group (treatment completed with the aid of AV eyeglasses). We will assigne each of these two treatments to either left or right halves of the primary dentition. The duration for the iPad session and the eyeglasses session will be the time required to complete pulpotomy (about 30 minutes). The interval between the iPad session and eyeglasses session will be 1 week. we will offer children the option to choose one game or movie from a pool of 6 games/movies (AV eyeglasses movies: Sponge Bob Square Pants (Viacom International Inc.), Tom and Jerry (Cartoon Network), and Shaun the Sheep (Asrdman Animations Ltd.); iPad VGs: Air Hockey Gold (Acceleroto), Paper Toss (Backflip Studios, Inc.), and Ninja Jump (Ninja Jump, Inc.).
Sponsors
Reem Attar
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
4 Years to 9 Years
Healthy volunteers
No
Inclusion criteria
children should be 4 to 9 years old, with no medically or developmentally compromising conditions, and in need of vital pulp therapy treatment in the posterior region of the mouth. Each child patient should have at least two primary antimere molars with lesions of similar size requiring restorative treatment including pulpotomy.
Exclusion criteria
Children with mental or cognitive problems that could compromise their basic comprehension of the trial and its conduct, those who were or are undergoing medical or dental treatment that might affect their behavior during the study, and those with heartbeat disorders. We will exclude children from the final analysis if they or their parents abandoned the study by their choice or any other reasons.
Outcome results
None listed