Plain English Summary
Background and study aims
Studies have found that the anaesthetic articaine is more effective and has comparable safety to the anaesthetic lidocaine when used as in routine dental treatments on permanent teeth in adults. However, as far as we are aware there no studies have been conducted to compare the effectiveness of articaine to lidocaine during dental treatment of children’s primary molar teeth (i.e., milk teeth). Therefore, the aim of this study is to compare the anaesthetic effectiveness of articaine and lidocaine in the dental treatment of primary molars in children aged 5-9. We will also evaluate the response of children when they receive the local anaesthetic injection, in order to recommend the most effective and acceptable method of injection.
Who can participate?
Children aged 5-9 who are attending Leeds Dental Hospital for dental treatment.
What does the study involve?
Participants are randomly allocated into two groups. One group is treated with articaine and the other group is treated with lidocaine. The child’s reaction to the injection is assessed by asking them to rate the pain, discomfort and numbness. The acceptability of the treatment is assessed using a questionnaire.
What are the possible benefits and risks of participating?
The participant may not personally benefit but we are hoping to find out which is the most effective treatment for future use. The risks are the same as any other routine dental treatment, including pain, discomfort, strange feeling of numbness, and lip or cheek biting.
Where is the study run from?
Leeds Dental Institute, University of Leeds (UK).
When is the study starting and how long is it expected to run for?
January 2013 to September 2015.
Who is funding the study?
University of Leeds (UK).
Who is the main contact?
Dr Fatma Alzahrani
Trial website
Additional identifiers
EudraCT number
2011-004711-23
ClinicalTrials.gov number
Protocol/serial number
DT11/9936
Study information
Scientific title
Comparative studies of the anaesthetic efficacy of 4% Articaine with 1:100,000 epinephrine used as mandibular infiltration versus 2% Lidocaine with 1:80,000 epinephrine used as inferior dental nerve block, in extraction and restoration of mandibular primary molars
Acronym
Study hypothesis
There is no difference in the pain experience between mandibular infiltration using 4% articaine with 1:100,000 epinephrine and the conventional technique inferior alveolar nerve block using 2% lidocaine with 1:80,000 epinephrine in dental treatment of mandibular primary molars.
Ethics approval
Not provided at time of registration
Study design
Parallel prospective randomised control trial
Primary study design
Interventional
Secondary study design
Randomised parallel trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information
Condition
Dental caries
Intervention
We will randomly assign the subjects into 2 groups; one group (Treatment group) will receive mandibular infiltration with 4% articaine with 1:100,000 and the other group (Control group) will receive inferior alveolar nerve block with 2% lidocaine with 1:80,000.
All local anaesthetic injections will be given by a single operator ,who will assess the child behaviour during the injection procedures (using Frankl Behaviour Scale). Each child will receive one treatment for one tooth only. The assessment will be done during all the procedures.
Intervention type
Drug
Phase
Not Applicable
Drug names
Articaine, Lidocaine
Primary outcome measure
Successful completion of treatment
Secondary outcome measures
1. Child perception of the treatment using specific questionnaire developed by the researcher
2. Parent perception of the treatment using specific questionnaire developed by the researcher
Overall trial start date
01/01/2013
Overall trial end date
01/09/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Children aged 5 to 9 years
2. Medically fit
3. Requiring extraction /restoration of primary mandibular molars teeth under local anaesthetic
4. Understand English
5. Mentally capable of communication
6. Tooth has no history of infection (abscess) or swelling and no evidence of periapical pathosis
7. The roots resorption of the primary tooth must be less than half of the root
8. Parents/guardian must give informed written consent prior to participation
9. Child must give assent form prior to participation, as well as parental consent
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
110
Total final enrolment
98
Participant exclusion criteria
1. Medically and mentally compromised children
2. History of significant behaviour management problems
3. Evidence of infection near the proposed injection site as this might affect the efficacy of local anaesthesia
4. Child does not speak English
Recruitment start date
01/01/2013
Recruitment end date
01/09/2015
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Leeds
Leeds
LS2 9LU
United Kingdom
Sponsor information
Organisation
University of Leeds (UK)
Sponsor details
Leeds Dental Institute
Clarendon Way
Leeds
LS2 9LU
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
University of Leeds (UK) ref: DT11/9936
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
Universities (academic only)
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2018 results in https://pubmed.ncbi.nlm.nih.gov/29573375/ (added 15/10/2020)