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.: PACTR202311916835461 Date of Approval: 08/11/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Efficacy of Sodium bicarbonate buffered lidocaine anaesthetic solution
Official scientific title Efficacy of sodium bicarbonate buffered lidocaine hydrochloride for local anaesthesia in intra-alveolar extraction of mandibular molars: a randomised controlled double-blind study
Brief summary describing the background and objectives of the trial Ideal tooth extraction is the painless removal of the whole tooth, or tooth root, with minimal trauma to the investing tissues. Local anaesthesia (LA) is the commonest method used in tooth extraction and it can be achieved in three different ways, namely topical, infiltration, and block. In the mandible, the block technique is mostly used to achieve anaesthesia in the extraction of molars. Pain on injection, long waits, inadequate anaesthesia, and failure to achieve anaesthesia are some of the challenges of the block technique. The prevalence of failure to achieve anaesthesia has been reported to be in the range of 15-40%. To mitigate these challenges, various approaches have been used including the slow speed of injection, warming LA cartridges, application of topical anaesthetic agents, and buffering of LA agents. Lidocaine is the most common anaesthetic agent in use in dentistry while Sodium bicarbonate (NaHCO3) is the most commonly used buffering agent. Studies have been done to compare the efficacy of NaHCO3 buffered lidocaine with convectional lidocaine but with varying outcomes. However, none has evaluated efficacy in terms of failure to achieve anaesthesia Objectives are: 1. To determine the efficacy, degree of pain on injection, and the anaesthetic onset of action when a sterile water-diluted and NaHCO3 buffered LA solution is used for the extractions of mandibular first and second molars. 2. To compare the efficacy, degree of pain on injection, anaesthetic onset of action, and comfort of the entire extraction procedure between participants using LA diluted with sterile water and those with LA buffered with NaHCO3.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Oral Health
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Sodium bicarbonate buffered Lidocaine
Anticipated trial start date 02/02/2021
Actual trial start date 02/02/2021
Anticipated date of last follow up 24/11/2022
Actual Last follow-up date 24/11/2022
Anticipated target sample size (number of participants) 220
Actual target sample size (number of participants) 220
Recruitment status Completed
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Sodium bicarbonate 0.18ml of 8.4% Sodium bicarbonate solution was used to buffer 1.8ml cartridge containing 2% Lidocaine hydrochloride 1:100,000 adrenaline to give a total of 1.98ml of constituted solution. once 1.98ml of NaHCO3 buffered lidocaine solution was administered to participants using Halstead technique, anaesthetizing the inferior alveolar nerve, lingual nerve and long buccal nerve in order to achieve local anaesthesia in the mandible. 110
Control Group Sterile water 0.18ml once 1.98ml of sterile water diluted lidocaine solution was administered to participants using Halstead technique, anaesthetizing the inferior alveolar nerve, lingual nerve and long buccal nerve in order to achieve local anaesthesia in the mandible. 110 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Patients requiring intra-alveolar extraction of mandibular first and/or second molar. 2. Patients between the ages of 18-60years 3. Patients with American Society of Anesthesiologists (ASA) I and II health status at the time of treatment. 1. Patients with known underlying systemic diseases such as bleeding dyscrasia and immunosuppression [e.g. uncontrolled diabetes mellitus, clotting disorder, hyperthyroidism, arteriosclerosis, cardiac insufficiency, other cardiovascular disorders, Auto-immunodeficiency Syndrome (AIDS)]. 2. Patients with allergy or hypersensitivity to any of the constituents of the anaesthetic solution in the surgical protocol. 3. Patients on anticoagulants 4. Patients taking any medications that would alter pain perception (opioids, synthetic cannabinoids, hallucinogens, antidepressants, anticonvulsants, methamphetamine, cocaine, benzodiazepines, 3,4-Methylenedioxymethamphetamine, Serotonin-Norepinephrine Re-uptake Inhibitors) 5. Patients who are current smokers and chronic alcoholics for more than two months 6. Patients with cognitive or physical impairment 7. Pregnant women and/or breastfeeding mothers 8. Inability to give informed consent 9. Teeth with abscess at the time of extraction Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 60 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 07/10/2020 Lagos University Teaching Hospital Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Ishaga road surulere surulere 12003 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Efficacy in term of failure to achieve anaesthesia 5 minutes after the administration of maximum of 2 cartridges of 1.98ml following objective testing
Secondary Outcome degree of pain on injection Immediately after administration of either buffered or diluted LA
Secondary Outcome Anaesthetic onset of action subjective assessment was when participant indicated tongue /or lip numbness while objective assessment was when anaesthesia was confirmed by probing
Secondary Outcome Comfort of the extraction procedure 30 minutes post-operatively
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Extraction clinic of the Oral and Maxillofacial surgery department Lagos University Teaching Hospital Idi Araba Lagos Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
none none none Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor myself LUTH surulere Nigeria Myself
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ebenezer Ajoloko hebhinizha@gmail.com +2348166055330 Ishaga road
City Postal code Country Position/Affiliation
lagos Nigeria Resident doctor
Role Name Email Phone Street address
Scientific Enquiries Michael Adeyemi adeyemimikola@yahoo.com +2348035805911 ishaga road
City Postal code Country Position/Affiliation
lagos Nigeria Senior Lecturer and consultant College of medicine University of Lagos Akoka
Role Name Email Phone Street address
Public Enquiries Ebenezer Ajoloko hebhinizha@gmail.com +2348166055330 Ishaga road
City Postal code Country Position/Affiliation
Lagos Nigeria Resident doctor of Department of Oral and Maxillofacial surgery at LUTH lagos
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All individual participant will be available Individual participant data that underlie the results reported after deidentification will be made available The study protocol will be available Data will be available immediately following publication with no end date Data will be shared with anyone who wishes to access it and for any purpose The data are available indefinitely at the Link to be included Study Protocol 12 months controlled access
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information