Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201802003023333 Date of Approval: 27/01/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparison of the anaesthetic effects of 4% articaine hydrochloride and 2% lidocaine hydrochloride for maxillary molar extraction: A randomised trial
Official scientific title Comparison of the anaesthetic effects of 4% articaine hydrochloride and 2% lidocaine hydrochloride for maxillary molar extraction: A randomised double blind crossover study.
Brief summary describing the background and objectives of the trial DEFINITION OF RESEARCH PROBLEM Many reports in Europe and America have suggested that articaine has superior dental anaesthetic properties over lidocaine. (Hendolin and Mattila 1974, Oertel et al 1997, Isen 2000, CRA Newsletter 2002, Van Eden and Patel 2002, Mclure and Rubin 2005 ). These claims include ability to achieve more profound anaesthesia (CRA Newsletter 2002), success of buccal infiltration in the maxilla to achieve palatal anaesthesia (Oertel et al 1997, Van Eden and Patel 2002, Shahid et al 2011), faster onset of action and longer duration of anaesthesia (Oertel et al 1997, CRA Newsletter 2002, Van Eden and Patel 2002, Shahid et al 2011). However, none of these studies was carried out in a black population. Considering the fact that there are known differences in bone densities between races which may affect anaesthetic response (Bruce et al. 1997, Ningning 2012, Chia-Hui et al. 2013). This study is designed to determine if the reported superior efficacy of articaine over lidocaine as a local anaesthetic agent for dental extraction is equally applicable to a black population. If these merits can be proven among Nigerian patients without associated serious adverse reactions, articaine could be adopted as a better alternative to lidocaine. This will improve the dental experience of a large proportion of patients. OBJECTIVES: 1 To determine and compare the onset of anaesthesia of articaine with lidocaine in maxillary nerve infiltration during extraction of maxillary molars. 2 To evaluate the relative effectiveness of articaine and lidocaine as local anaesthetic agents in maxillary nerve infiltration during extraction of maxillary molars. 3 To determine, and compare duration of action of articaine versus lidocaine in maxillary nerve infiltration during extraction of maxillary molars. 4 To determine and compare the adverse effects of articaine hydrochloride with lidocaine hydrochloride following maxillary nerve infiltration
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Compairing two types of local anaesthetic agents on pain control during dental extractions.,Oral Health
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 05/01/2015
Actual trial start date 04/01/2016
Anticipated date of last follow up 30/03/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 14
Actual target sample size (number of participants) 16
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Crossover: all participants receive all interventions in different sequence during study Randomised Simple randomisation using by using procedures such as coin-tossing or dice-rolling Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Extraction of upper molar tooth using ARTICAINE 1.7ml (Any extra volume used is added) Within an hour After randomly selecting between articaine and lidocaine in the first visit, an extraction is done with the agent selected. Onset of action, duration of anaesthesia are recorded with stop watch. Effectiveness of anaesthesia are recorded by measuring pain perception in buccal and palatal sulci 10 minutes after buccal injection and immediately after extraction. Ability of buccal injection to achieve 14
Control Group Extraction of upper molar tooth using LIDOCAINE 1.7ml (Any extra volume used is added) Within an hour After the first visit, the second extraction of the corresponding upper molar tooth on the opposite side is done after 2 weeks with the other anaesthetic agents on the same patient. ( If articaine is selected in first visit, lidocaine is used in second visit and vice versa). Similar recordings are done on second visit on the same patient. The only difference is anaesthetic agents used. 14 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1 Patients that require bilateral extraction of corresponding firm maxillary molar teeth. Acute pulpitis Chronic pulpitis. Acute exacerbation of chronic apical periodontitis. Pre-orthodontic extraction. Chronic apical periodontitis. 2 Patients that are between the ages of 18 and 40 years. 3 Patients that require simple, intra-alveolar extraction only. 4 Consenting patients. 5 Fully erupted teeth. 1 Presence of underlying systemic diseases such as hypertension, diabetes, blood dyscrasias etc. 2 Non consenting patients. 3 Extractions that end in root fracture. 4 Impacted teeth. 5 Presence of inflammatory conditions such as dentoalveolar abscess. 6 Patients on medication that can interfere with local anaesthetic agents such as meperidine, phenytoin, quinidine and cimetidine. 7 Chronic alcoholic patients 18 Year(s) 40 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 28/01/2014 University of Nigeria Teaching Hospital Health Research Ethics Committee.
Ethics Committee Address
Street address City Postal code Country
Km 21 Enugu-Port Harcourt Express Road, Ituku-Ozalla Enugu 400001 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Effectiveness of anaesthesia is recorded based on patients' score of the level of pain experienced during extraction exercise for each side of jaw and pain level in buccal and palatal gingival sulci 10 minutes after buccal infiltration usin visual analog scale chart recording. 1] Effectiveness of anaesthesia in buccal and gingival sulcus is recorded 10 minutes after buccal infitration. 2] Effectiveness of palatal injection is recorded 4 minutes after palatal injection. 3]Effectiveness of anaesthesia during extraction is recorded immediately after extraction.
Primary Outcome To determine and compare the effectiveness of buccal infiltrations in anaesthesizing palatal nerve during extraction of upper molars. Using both articaine and lidocaine as anaesthetic agents. 10 minutes after buccal infitration
Secondary Outcome To determine and compare onset of action of articaine with lidocaine during extraction of maxillary molaes within 5 minutes
Secondary Outcome To determine and compare complications of articaine with lidocainne during upper molar extractions Within 1 hour
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Nigeria Teaching Hospital Km 21, E nugu-Port Harcourt Express way, Ituku-ozalla. Enugu 400001 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr Adigun Olufemi Ibraheem Km 21, E nugu-Port Harcourt Express way, Ituku-ozalla. Enugu 400001 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr Adigun Olufemi Ibraheem Km 21, E nugu-Port Harcourt Express way, Ituku-ozalla. Enugu 400001 Nigeria Charities/Societies/Foundation
Secondary Sponsor Dr Uguru Chibuzo C. Km 21, E nugu-Port Harcourt Express way, Ituku-ozalla. Enugu 400001 Nigeria Charities/Societies/Foundation
Secondary Sponsor Dr Akadiri Oladimeji A. University of Port harcourt Teaching Hospital Port Harcourt 500001 Nigeria Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Dr Uguru Chibuzo C. Km 21, E nugu-Port Harcourt Express way, Ituku-ozalla. Enugu 400001 Nigeria
Dr Akadiri Oladimeji A. University of Port harcourt Teaching Hospital Port Harcourt 500001 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Olufemi Ibraheem adigunolufemi23@yahoo.com +2348097042892 Km 21, Enugu-Port harcourt Express Road, Ituku-Ozalla
City Postal code Country Position/Affiliation
Enugu 400001 Nigeria Senior registrar
Role Name Email Phone Street address
Public Enquiries Oladimeji Akadiri oaakadiri@yahoo.com 07038167498 University of Port harcourt Teaching Hospital
City Postal code Country Position/Affiliation
Port harcourt 500001 Nigeria Supervisor
Role Name Email Phone Street address
Scientific Enquiries Chibuzo Uguru chibazh@yahoo.com 08037270309 Km 21, Enugu-Port harcourt Express Road, Ituku-Ozalla
City Postal code Country Position/Affiliation
Enugu 400001 Nigeria Supervisor
REPORTING
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