Condition category
Oral Health
Date applied
17/09/2012
Date assigned
12/10/2012
Last edited
08/10/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Prof Monty Duggal

ORCID ID

Contact details

Consultant and Head of Paediatric Dentistry
University of Leeds
Child Dental Health
Leeds Dental Institute
Clarendon Way
Leeds
LS2 9LU
United Kingdom

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 measures

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

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

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

http://www.leeds.ac.uk/

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

academic

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes