Comparing two local anaesthetic drugs in treatment of children's teeth
| ISRCTN | ISRCTN11415977 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11415977 |
| EudraCT/CTIS number | 2011-004711-23 |
| Secondary identifying numbers | DT11/9936 |
- Submission date
- 17/09/2012
- Registration date
- 12/10/2012
- Last edited
- 15/10/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
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
Contact information
Scientific
Consultant and Head of Paediatric Dentistry
University of Leeds
Child Dental Health
Leeds Dental Institute
Clarendon Way
Leeds
LS2 9LU
United Kingdom
Study information
| Study design | Parallel prospective randomised control trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/01/2013 |
| Completion date | 01/09/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 5 Years |
| Upper age limit | 9 Years |
| Sex | Both |
| Target number of participants | 110 |
| Total final enrolment | 98 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/01/2013 |
| Date of final enrolment | 01/09/2015 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
LS2 9LU
United Kingdom
Sponsor information
University/education
Leeds Dental Institute
Clarendon Way
Leeds
LS2 9LU
England
United Kingdom
| Website | http://www.leeds.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/024mrxd33 |
Funders
Funder type
University/education
Private sector organisation / Universities (academic only)
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2018 | 15/10/2020 | Yes | No |
Editorial Notes
15/10/2020: Publication reference and total final enrolment number added.
31/05/2019: Internal review.
24/01/2018: No publications found in PubMed, verifying study status with principal investigator.
