Dental research comparing two types of local anaesthetic in dental treatment of children's teeth.

Conditions: Dental caries in primary molars
Therapeutic area: Diseases [C] - Mouth and tooth diseases [C07]

Registration Number: EUCTR2011-004711-23-GB

Lead Sponsor: eeds Dental Institute

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

a) Children aged 5–9 years.
b) Medically fit (ASA I,II).
c) Requiring extraction /restoration (pulpotomy treatment) of primary mandibular molar teeth
under local anaesthetic.
d) Understanding of English.
e) Mentally capable of communication.
f) Tooth without history of infection (abscess) or swelling and no evidence of periapical
pathosis or soft tissue infection/inflammation near site of injection.
g) Root resorption of the primary tooth must be less than two-thirds of the root.
h) Child must give assent form prior to participation, as well as parental informed written
consent.
i) Body weight more than 20 Kg.
Are the trial subjects under 18? yes
Number of subjects for this age range: 110
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

a) Medically and mentally compromised children.
b) History of significant behaviour management problems
c) Evidence of infection near the proposed injection site as this might affect the efficacy of local anaesthesia.
d) Child does not speak English.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 1- To evaluate and compare the anaesthetic efficacy of mandibular infiltration using 4% Articaine (1:100,000 epinephrine) with mandibular nerve block using 2% Lidocaine (1:80,000 epinephrine) in achieving adequate analgesia for extraction and pulpotomy of mandibular primary molars.<br> 2- To evaluate the response and reaction of children when they receive the local anaesthetic injection, and the occurrence of adverse events in treated children in order to recommend the most effective and acceptable method of injection for the treatment of primary teeth in children.;Secondary Objective: To assess the acceptability of the treatment by both the child and parent using a designed questionnaire;Primary end point(s): Successful completion of treatment.;Timepoint(s) of evaluation of this end point: By the end of dental visit.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Child perception of the treatment.<br>- Parent perception of the treatment.;Timepoint(s) of evaluation of this end point: By the end of dental visit.