Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000889055
Ethics application status
Approved
Date submitted
18/10/2010
Date registered
19/10/2010
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 dental local analgesia among children for dental extractions
Scientific title
Effectiveness of 4% Articaine with 1:100,000 adrenaline in achieving local analgesia through buccal infiltration for dental extraction in the upper jaw among children.
Secondary ID [1] 252900 0
nil
Universal Trial Number (UTN)
U1111-1117-5206
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
dental local analgesia 258436 0
Condition category
Condition code
Oral and Gastrointestinal 258600 258600 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Anaesthesiology 258601 258601 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparison of the effectiveness of 4% Articaine with 1:100,000 adrenaline compared with Lignocaine 2% with 1:100,000 adrenaline in achieving local analgesia for dental extractions in the upper jaw among children when delivered as buccal infiltration only adjacent to the tooth to be extracted. Dosage of local anaesthetic limited to 5mg/kg body weight, to a maximum of 2.2ml cartridge of local anaesthetic. Supplementation with Lignocaine 2% permitted for palatal analgesia, dosage not to exceed 5mg/kg body weight. Mode of administration: buccal infiltration injection. Type of anaesthetic used (test or control) for one side of the mouth determined by random allocation.
Intervention code [1] 257432 0
Treatment: Drugs
Comparator / control treatment
Comparison local anaesthetic is 2% lignociane with 1:100,000 adrenaline delivered in the same manner as the test agent on the contralateral side. Both teeth can be extracted at the same visit or one at each visit, usually spaced 1 week apart.
Control group
Active

Outcomes
Primary outcome [1] 259449 0
Proportion of children with achievement of local analgesia through buccal infiltration alone to allow extraction of upper teeth among study participants. Achievement of analgesia initially tested through tactile probing after maximum of ten minutes wait after analgesia administration. If analgesia is deemed adequate extraction is performed.
Timepoint [1] 259449 0
Analgesia tested after 10 minutes from administration of local analgesia.
Secondary outcome [1] 266002 0
Child's report of pain as reported through the faces pain scale
Timepoint [1] 266002 0
After completion of local analgesia administration and after extraction. If both teeth are extracted at the same visit the recorder ensures that child's response is for the indicated tooth.
Secondary outcome [2] 266003 0
Assistant observation of child's reaction to administration of local analgesia and during extraction using the CHEOPS scale
Timepoint [2] 266003 0
Assistant record the observations during local anaesthetic administration and during extraction
Secondary outcome [3] 266004 0
Parental report of postoperative pain through completion of parent questionnaire
Timepoint [3] 266004 0
Questionnaire completed 24 hours after completion of the procedure.
Secondary outcome [4] 266005 0
Reports of adverse events pain at injection site, excessive and or prolonged post operative bleeding and soft tissue injuries.
Timepoint [4] 266005 0
Verbal reports obtained through phone contact or text messaging 24 hours after completion of extraction.

Eligibility
Key inclusion criteria
Child registered with Dental Health Services WA. Child requires bilateral maxillary permanent teeth requiring extractions as part of orthodontic treatment as requested by specialist orthodontist
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. body weight below 30 kg.

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 both parent and child when a request from orthodontist received at a dental clinic requesting extraction of bilateral maxillary permanent teeth as part of overall orthodontic management for the child. The use of local anaesthetic agent determined by random allocation using computer generated block randomisation by a study coordinator by phone located at a remote site.
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), type of anaesthetic used at first visit determined by random assignment.
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
2/03/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 3355 0
6112
Recruitment postcode(s) [2] 3356 0
6992
Recruitment postcode(s) [3] 3357 0
6123
Recruitment postcode(s) [4] 3358 0
6111

Funding & Sponsors
Funding source category [1] 257869 0
Other
Name [1] 257869 0
Dental Health Services Western Australia
Country [1] 257869 0
Australia
Primary sponsor type
Other
Name
Dental Health Services Western Australia
Address
43 Mt Henry Road
Como, 6152
Perth, Western Australia
Country
Australia
Secondary sponsor category [1] 257070 0
Commercial sector/Industry
Name [1] 257070 0
Septodont
Address [1] 257070 0
PO Box 288

EMU PLAINS NSW 2750
Country [1] 257070 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259900 0
University of Western Australia Human Research Ethics Committee
Ethics committee address [1] 259900 0
Ethics committee country [1] 259900 0
Australia
Date submitted for ethics approval [1] 259900 0
10/11/2009
Approval date [1] 259900 0
08/01/2010
Ethics approval number [1] 259900 0
RA/4/1/2609

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

Contacts
Principal investigator
Name 31795 0
Address 31795 0
Country 31795 0
Phone 31795 0
Fax 31795 0
Email 31795 0
Contact person for public queries
Name 15042 0
peter arrow
Address 15042 0
Australian Research Centre for Population Oral Health
University of Adelaide
Level 1
122 Frome Street
Adelaide, South Australia 5000
Country 15042 0
Australia
Phone 15042 0
+61 08 8303 4171
Fax 15042 0
Email 15042 0
[email protected]
Contact person for scientific queries
Name 5970 0
peter arrow
Address 5970 0
Australian Research Centre for Population Oral Health
University of Adelaide
Level 1
122 Frome Street
Adelaide, South Australia 5000
Country 5970 0
Australia
Phone 5970 0
+61 08 8303 4171
Fax 5970 0
Email 5970 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.