Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000459628
Ethics application status
Approved
Date submitted
20/04/2014
Date registered
2/05/2014
Date last updated
2/05/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Distraction using an iPad during pulpotomy in children
Scientific title
Comparative efficacy of active distraction and passive distraction during pulpotomy in children: Audiovisual eyeglasses versus an iPad—A randomized controlled trial
Secondary ID [1] 284468 0
Nil
Universal Trial Number (UTN)
U1111-1155-9482
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain during dental treatment in children. 291700 0
Fear and anxiety from dental treatment. 291701 0
Condition category
Condition code
Alternative and Complementary Medicine 292079 292079 0 0
Other alternative and complementary medicine
Oral and Gastrointestinal 292132 292132 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.).
Intervention code [1] 289223 0
Treatment: Devices
Comparator / control treatment
Active control (audiovisual eyeglasses). It will be applied during the time required to complete pulpotomy (about 30 minutes).
we will offer children the option to choose one movie from a pool of 3 movies (AV eyeglasses movies: Sponge Bob Square Pants (Viacom International Inc.), Tom and Jerry (Cartoon Network), and Shaun the Sheep (Asrdman Animations Ltd.).
Control group
Active

Outcomes
Primary outcome [1] 291952 0
Effectiveness of an iPad versus audiovisual glasses in controlling pain (pain perceived by a patient as measured by Wong-Baker Faces Pain Scale) and reducing disruptive behavior (as measured by North Carolina Behavior Rating Scale) during dental treatments in children.
Timepoint [1] 291952 0
Pain and behavior will rated during treatment. The ratings will be made at 7 separate intervals: (1) 5 minutes before treatment (BT), (2) during administration of local anesthesia (LA), (3) after rubber dam clamp placement (RD), (4) during caries removal (CR), (5) during pulp amputation (PA), (6) during insertion of the restorative material (RM), and (7) 5 minutes postoperatively (PO).
Secondary outcome [1] 307909 0
Effect of an iPad versus audiovisual glasses on heart rates of children during dental treatment. Child’s heart rates will be recorded during those intervals using a fingertip pulse oximetry
Timepoint [1] 307909 0
The heart rate recording will be made at 7 separate intervals: (1) 5 minutes before treatment (BT), (2) during administration of local anesthesia (LA), (3) after rubber dam clamp placement (RD), (4) during caries removal (CR), (5) during pulp amputation (PA), (6) during insertion of the restorative material (RM), and (7) 5 minutes postoperatively (PO).

Eligibility
Key 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.
Minimum age
4 Years
Maximum age
9 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
We will randomly assigne child patients to receive the treatment using an iPad (Group A) at one visit, while the AV eyeglasses will be used at the second visit. Each of those in Group B will receive the same two treatments, but in reverse order. For each child patient, random selection will determine which tooth would be treated by which method of distraction. Both types of distraction techniques will be given to all child participants along with local anesthesia.
The person who determined if a subject will be eligible for inclusion in the trial was unaware, when this decision was made, to which group the subject would be allocated. Allocation will involve contacting the holder of the allocation schedule who is not part of the study's investigators.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Coin toss.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Split-mouth design.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The 2 distraction techniques will be compared by the Wilcoxon signed rank test for pain and behavior scores and paired t-test for heart rate scores.
A sample size calculation was performed based on Wilcoxon Paired Signed Rank test, assuming the standard deviation of 1.53 (based on a 4-point scale for pain from none to severe) and a paired difference of 1 (effect size ES 0.65). When alpha 0.05 and ES 0.65, the sample size required for a power of 0.84 would be 23 participants (pairs). The sample size was increased to 50 to increase the study's power and to compensate for participants' drop-out.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/09/2013
Actual
10/09/2013
Date of last participant enrolment
Anticipated
31/08/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 6016 0
Saudi Arabia
State/province [1] 6016 0
Riyadh

Funding & Sponsors
Funding source category [1] 289114 0
Self funded/Unfunded
Name [1] 289114 0
Reem Attar
Country [1] 289114 0
Saudi Arabia
Funding source category [2] 289115 0
Self funded/Unfunded
Name [2] 289115 0
Ziad Baghdadi
Country [2] 289115 0
Saudi Arabia
Funding source category [3] 289116 0
Hospital
Name [3] 289116 0
Riyadh Colleges Dental Teaching Hospital
Country [3] 289116 0
Saudi Arabia
Primary sponsor type
Individual
Name
Reem Attar
Address
Riyadh Colleges Dentistry & Pharmacy
P.O. Box 84891 Riyadh 11681, Kingdom of Saudi Arabia
Country
Saudi Arabia
Secondary sponsor category [1] 287777 0
None
Name [1] 287777 0
Address [1] 287777 0
Country [1] 287777 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290897 0
Riyadh Colleges of Dentistry and Phramacy Postgraduate Committee
Ethics committee address [1] 290897 0
Ethics committee country [1] 290897 0
Saudi Arabia
Date submitted for ethics approval [1] 290897 0
31/12/2012
Approval date [1] 290897 0
01/02/2013
Ethics approval number [1] 290897 0
PGRP/43235002/34

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 47866 0
Dr Ziad D. Baghdadi
Address 47866 0
Riyadh Colleges Dentistry & Pharmacy
P.O. Box 67126
Riyadh 11596
Country 47866 0
Saudi Arabia
Phone 47866 0
+966564181589
Fax 47866 0
Email 47866 0
[email protected]
Contact person for public queries
Name 47867 0
Ziad D. Baghdadi
Address 47867 0
Riyadh Colleges Dentistry & Pharmacy
P.O. Box 67126
Riyadh 11596
Country 47867 0
Saudi Arabia
Phone 47867 0
+966564181589
Fax 47867 0
Email 47867 0
[email protected]
Contact person for scientific queries
Name 47868 0
Ziad D. Baghdadi
Address 47868 0
Riyadh Colleges Dentistry & Pharmacy
P.O. Box 67126
Riyadh 11596
Country 47868 0
Saudi Arabia
Phone 47868 0
+966564181589
Fax 47868 0
Email 47868 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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