Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000873022
Ethics application status
Approved
Date submitted
14/10/2010
Date registered
18/10/2010
Date last updated
29/08/2024
Date data sharing statement initially provided
29/08/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
effectiveness of local dental anaesthetic in children
Scientific title
effectiveness of Articaine 4% with 1:100,000 adrenaline in obtaining local dental analgesia of the lower back teeth among children
Secondary ID [1] 252872 0
Nil
Universal Trial Number (UTN)
U1111-1117-4944
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
dental local analgesia 258401 0
Condition category
Condition code
Oral and Gastrointestinal 258566 258566 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Anaesthesiology 258590 258590 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparison of the effectiveness of articaine 4% against lignocaine 2% in obtaining dental local analgesia among children when delivered as a buccal infiltration or inferior alveolar nerve block injections for restorative procedures in mandibular posterior teeth. Dosage of trial anaesthetic limited only to a maximum of 2.2 ml cartridge of the local anaesthetic agent. Dosage of local analgesic agent titrated to maximum of 5 mg/kg body weight. If local analgesia was not achieved with the trial anaesthetic patient reappointed for another appointment for the treatment to be completed using standard treatment protocol or supplement with standard local anaesthetic (Lignociane 2%) if the weight of the child allowed supplementation, doseage not to exceed 5mg/kg body weight. Mode of administration, buccal or inferior alveolar block, and type of local anaesthetic used at first visit, test or control, determined by random allocation.
Intervention code [1] 257399 0
Treatment: Drugs
Comparator / control treatment
Lignocaine 2% with 1:100,000 adrenaline. Mode of administration the same method as determined for the test anaesthetic, but on the contralateral side of the mouth.
Control group
Active

Outcomes
Primary outcome [1] 259414 0
Proportion of children with successful local analgesia to complete restorations in mandibular posterior teeth. Child's response and report of no sensation of pain on undertaking restorative procedures using conventional air-turbine and engine driven rotary cutting hand-pieces was used as indicator of adequacy and success of local analgesia.
Timepoint [1] 259414 0
The restorative procedures commenced 5 minutes after completion of local anaesthetc administration with a further wait of another 5 minutes if discomfort was reported.
Secondary outcome [1] 265954 0
Child's report of pain
Timepoint [1] 265954 0
Observations taken by assistant using the faces pain scale after completion of local anaesthetic administration and restorative treatment.
Secondary outcome [2] 265989 0
parental report of parent/carer on pain by completing a parent report of pain questionnaire.
Timepoint [2] 265989 0
24 hours after procedure
Secondary outcome [3] 265990 0
observation of child's reactions
Timepoint [3] 265990 0
during administration of local anaesthetic and during restorative procedures, observations taken by dental assistant using the CHEOPS pain scale.
Secondary outcome [4] 265991 0
verbal reports of any adverse events; pain at injection site, pain elsewhere, soft tissue injury (lip biting).
Timepoint [4] 265991 0
Contact with child/parent at 2 hours, 4 hours, 24 hours and 7 days after completion of local anaesthetic administration by phone, text messaging.

Eligibility
Key inclusion criteria
Child registered with the School Dental Service in Western Australia. Minimum body weight 20 kg.
Require carious bilateral mandibular posterior teeth restored.
Minimum age
5 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
There must be no:
a. History of allergy to local anaesthetic or any of its constituents.
b. Medical conditions contraindicating the use of local analgesia or to undergo dental treatment under local analgesia.
c. medications being taken likely to interfere with reporting of pain (analgesics).
d. Neurological disorders with sensory disturbances or communication difficulties.
e. Non-cooperative behaviour for dental treatment under local analgesia.
f. Difficulty with communicating effectively in the English language.
g. Possibility of pregnancy.
h. Evidence of soft tissue infection/inflammation near site of injection.
i. Signs of irreversible pulpal involvement of the study teeth.

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)
Informed consent sought from child and parent when child presented for a recall examination and was found to be in need of restorative care on bilateral mandibular posterior teeth. Allocation was determined by a trial coordinator located at a remote site using a table of random numbers to select blocks by phone contact.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The child was allocated to receive test or control agent and order of administration determined by computer generated permuted blocks with block size determined by the computer.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
split mouth design. Child serves as both control and test with the trial anaesthetic delivered to either the right side or left side using the same mode of delivery for each child (buccal infiltration or block analgesia), type of anaesthetic used at first visit and technique of delivery of anaesthetic determined by random assignment.
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
No differnec in outcomes.
Date of first participant enrolment
Anticipated
10/03/2010
Actual
10/03/2010
Date of last participant enrolment
Anticipated
Actual
1/09/2011
Date of last data collection
Anticipated
Actual
1/09/2011
Sample size
Target
150
Accrual to date
Final
57
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 3314 0
6168
Recruitment postcode(s) [2] 3315 0
6169
Recruitment postcode(s) [3] 3316 0
6162

Funding & Sponsors
Funding source category [1] 257838 0
Other
Name [1] 257838 0
Dental Health Services Western Australia
Country [1] 257838 0
Australia
Primary sponsor type
Other
Name
Dental Health Services, Western Australia
Address
43 Mt Henry rd
Como, 6152
Perth, Western Australia
Country
Australia
Secondary sponsor category [1] 257040 0
Commercial sector/Industry
Name [1] 257040 0
Septodont
Address [1] 257040 0
PO Box 288

EMU PLAINS NSW 2750
Country [1] 257040 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259874 0
University of western Australia Human Research Ethics Committee
Ethics committee address [1] 259874 0
Ethics committee country [1] 259874 0
Australia
Date submitted for ethics approval [1] 259874 0
17/07/2009
Approval date [1] 259874 0
24/08/2009
Ethics approval number [1] 259874 0
RA/4/1/2451

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

Contacts
Principal investigator
Name 31772 0
Address 31772 0
Country 31772 0
Phone 31772 0
Fax 31772 0
Email 31772 0
Contact person for public queries
Name 15019 0
peter arrow
Address 15019 0
Australian Research Centre for Population Oral Health
University of Adelaide
Level 1
122 Frome Street
Adelaide, South Australia 5000
Country 15019 0
Australia
Phone 15019 0
+61 08 8303 4171
Fax 15019 0
Email 15019 0
[email protected]
Contact person for scientific queries
Name 5947 0
peter arrow
Address 5947 0
Australian Research Centre for Population Oral Health
University of Adelaide
Level 1
122 Frome Street
Adelaide, South Australia 5000
Country 5947 0
Australia
Phone 5947 0
+61 08 8303 4171
Fax 5947 0
Email 5947 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.