The efficacy of inferior alveolar nerve block and buccal infiltration for pulp anaesthesia in mandibular teeth” - Inferior alveolar nerve block with and without buccal infiltratio

Phase 1

• Conditions: /A. This work is of direct relevance to everyday general dental practice. The outcomes of this work are likely to influence the way in which paractitioners approach the problem of anaesthetising mandibular teeth, and as a consequence, volunteers are likely to benefit directly during dental attendances in the years to come.

• Registration Number: EUCTR2006-002042-11-GB
• Lead Sponsor: ewcastle Upon Tyne Hospitals NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-05-10
• Study Completion: 2007-02-02
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 36

Inclusion Criteria

(i) Healthy adults (age 18 or over) from the students and staff of the University and Dental Hospital.
(ii) Able to give informed consent.
(iii) Presence of responsive first molar, first/second premolar and lateral incisor teeth one one side of the mouth.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

(i) Under 18 years of age.
(ii) Relevant medical history which may compromise the welfare of the volunteer (e.g. unstable angina) or which may compromise data collection (e.g. altered facial or oral sensation).
(iii)Allergies or sensitivities to lidocaine, articaine or other components of local anaesthetic solutions.
(iv) Absence of responsive first molar, first/second premolar and lateral incisor teeth on one side of the mouth.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Main Objective: • To evaluate the effectiveness of lidocaine IANB alone and a supplementary<br> buccal infiltration with articaine after lidocaine IANB injection in securing pulp<br> anaesthesia in mandibular teeth.<br> ;<br> Secondary Objective: • To evaluate the discomfort associated with each injection.<br> • To determine the time of onset and duration of pulpal anaesthesia for each<br> technique.<br> • To assess patient reported feelings of numbness in teeth and soft tissues after<br> each local anaesthetic injection.<br> ;Primary end point(s): Does lidocaine inferior alveolar nerve block (IANB) with articaine buccal infiltration provide more episodes of no responses to maximum stimulation of pulp testing than IANB injection alone?