- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05793905
Buffered Anesthetic Solution in the Treatment of Mandibular Primary Molars
September 27, 2023 updated by: Damascus University
Evaluation of the Effect of Buffered Anesthetic Solution (Lidocaine 2%) in the Effectiveness of Inferior Alveolar Nerve Block Injection During the Treatment of Mandibular Primary Molars
In a prospective, randomized clinical trial, triple-blind, split-mouth study, 40 children aged between 7 to 10 with bilateral mandibular primary molars were diagnosed with pulpitis.
The test agent was 2% lidocaine with 1:80.000
epinephrine buffered with sodium bicarbonate 8.4% at a ratio of 1/10, as opposed to the control agent, which was non- buffered 2% lidocaine with 1:80,000 epinephrine.
The pain will be assessed during inferior alveolar nerve block injection (IANB) and the effectiveness of anesthesia using the subjective Wong-Baker visual analog scale, the objective sound, eye, and motor (SEM) scale, and the physiological pain scale (pulse rate) using a pulse oximeter.
The investigator has confirmed the onset of anesthesia after lip tongue-numbing by probing the gingiva until there is no pain.
Endo-ice has been used to assess the onset of pulp anesthesia.
Study Overview
Status
Completed
Conditions
Detailed Description
In a prospective, randomized clinical trial and triple-blind, split mouth study, 40 children aged between 7 to 10 with bilateral mandibular primary molars were diagnosed with pulpitis.
Random numbers between 1 to 40 were assigned to patients, with some receiving buffered lidocaine at their initial appointment while others received unbuffered lidocaine.
The solutions have been switched up for the second session, which has been set for one week later.
The test agent was 2% lidocaine with 1:80.000
epinephrine buffered with sodium bicarbonate 8.4% at a ratio of 1/10, as opposed to the control agent, non-buffering 2% lidocaine with 1:80,000 epinephrine.
Buffered lidocaine has been freshly prepared by mixing sodium bicarbonate (8.4%) with the anaesthetic solution (lidocaine 2% with epinephrine 1/80.000) in a 1:10 ratio by volume.
Two percent benzocaine gel is applied at the injection site for one minute before inferior alveolar nerve block injection (IANB).
The investigator has assessed pain during IANB injection using the subjective Wong-Baker visual analogue scale, the objective sound, eye, and motor (SEM) scale, and the physiological pain scale (pulse rate) using a pulse oximeter.
After administering the IANB injection, the investigator has confirmed the onset of anaesthesia after lip and tongue numbing by probing the gingiva every 30 seconds until there is no pain.
Endo-ice has been used to assess the onset of pulp anaesthesia every 30 seconds.
The effectiveness of anaesthesia has been assessed during the preparation of the pulp chamber using subjective, objective, and physiological pain scales.
Finally, the numerical data will be statistically analysed, and any statistically significant values will be investigated.
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Al-Mazzeh Saint
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Damascus, Al-Mazzeh Saint, Syrian Arab Republic, Damascus P.O.Box 3062
- College of dentistry.
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 10 years (Child)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Children who are healthy and free of any underlying conditions that might make local anesthesia impossible to administer.
- Children that are not allergic to (lidocaine, adrenaline, or sodium bicarbonate).
- Children aged 6-10 years old
- Cooperative children on Frankel scale (positive or absolute positive).
- children needing bilateral (right and left) endodontic treatment for the mandibular primary molars.
- A positive outcome on the cold test for the target tooth.
Exclusion Criteria:
- Uncooperative children on Frankel's scale (passive or absolute positive).
- The presence of a fistula.
- The presence of an abscess associated with the target tooth.
- The presence of a periapical lesion radially.
- Negative response to the cold test.
- Children suffering from systemic conditions.
- Children who are allergic to (lidocaine, adrenaline, sodium bicarbonate).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Buffered lidocaine
Inferior alveolar nerve block with buffered anesthetic solution (2% lidocaine with 1/80000 adrenaline mixed with sodium bicarbonate 8.4%)
|
Buffered Lidocaine 2% with epinephrine 1.80000 mixed with 1.8% sodium bicarbonate in IANB injection in the treatment of bilateral primary mandibular molars
Other Names:
|
Other: Lidocaine 2%
Control group: Inferior alveolar nerve block with anesthetic solution (Lidocaine 2% with adrenaline 1.80000). |
Lidocaine 2% with epinephrine 1.80000 in IANB injection in the treatment of bilateral primary mandibular molars
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Probing the gingiva
Time Frame: directly after asking the child about lip, tongue numbing every 30 seconds until there is no pain.
|
The onset of anaesthesia at soft tissue will be assessed by probing the gingiva After IANB injection.
|
directly after asking the child about lip, tongue numbing every 30 seconds until there is no pain.
|
Endo - ice test
Time Frame: Every 30 seconds after confirmed soft tissues anaesthesia until the absence of pain.
|
The investigator will use endo-ice to assess the onset time of pulp anaesthesia.
|
Every 30 seconds after confirmed soft tissues anaesthesia until the absence of pain.
|
Pulse rate
Time Frame: A minute before anaesthesia.
|
Pulse rate is a physiological pain scale which will be taken through a finger pulse oximeter.
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A minute before anaesthesia.
|
Pulse rate
Time Frame: 20 seconds after the first quarter of the local anaesthesia.
|
Pulse rate is a physiological pain scale, will be taken through a finger pulse oximeter.
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20 seconds after the first quarter of the local anaesthesia.
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Wong baker faces scale.
Time Frame: One minute after IANB injection
|
Wong Baker faces scale is a subjective pain which contains a series of six faces ranging from a happy face at 0 to indicate "no hurt" to a crying face at 10 to indicate "hurts worst"
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One minute after IANB injection
|
Sound, eye, motor scale (SEM)
Time Frame: Within five seconds from the start of the local anesthetic injection to completion
|
Sound, eye, motor scale is an objective pain scale for the assessment of child's behaviour by recording video during anaesthesia
|
Within five seconds from the start of the local anesthetic injection to completion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pulse rate
Time Frame: 20 seconds after opening the pulp chamber
|
Pulse rate is a physiological pain scale which will be taken through a finger pulse oximeter.
|
20 seconds after opening the pulp chamber
|
sound, eye, motor scale (SEM)
Time Frame: Within five seconds from the start of the local anaesthetic injection to completion
|
Sound, eye, motor scale is an objective pain scale for the assessment of child's behaviour by recording video during endo access preparation
|
Within five seconds from the start of the local anaesthetic injection to completion
|
Wong baker faces scale
Time Frame: one minute after preparing pulp chamber
|
Wong Baker faces scale is a subjective pain which contains a series of six faces ranging from a happy face at 0 to indicate "no hurt" to a crying face at 10 to indicate "hurts worst"
|
one minute after preparing pulp chamber
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Hanadi Almattit, Phd,lecturer, Co- supervisal
- Study Director: Chaza Kouchaji, Professor, Supervisal
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Chopra R, Jindal G, Sachdev V, Sandhu M. Double-Blind Crossover Study to Compare Pain Experience During Inferior Alveolar Nerve Block Administration Using Buffered Two Percent Lidocaine in Children. Pediatr Dent. 2016 Jan-Feb;38(1):25-9.
- Goodchild JH, Donaldson M. Novel Direct Injection Chairside Buffering Technique for Local Anesthetic Use in Dentistry. Compend Contin Educ Dent. 2019 Jul/Aug;40(7):e1-e10.
- Meincken M, Norman C, Arevalo O, Saman DM, Bejarano T. Anesthesia Onset Time and Injection Pain Between Buffered and Unbuffered Lidocaine Used as Local Anesthetic for Dental Care in Children. Pediatr Dent. 2019 Sep 15;41(5):354-357.
- Kurien RS, Goswami M, Singh S. Comparative evaluation of anesthetic efficacy of warm, buffered and conventional 2% lignocaine for the success of inferior alveolar nerve block (IANB) in mandibular primary molars: A randomized controlled clinical trial. J Dent Res Dent Clin Dent Prospects. 2018 Spring;12(2):102-109. doi: 10.15171/joddd.2018.016. Epub 2018 Jun 20.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2022
Primary Completion (Actual)
March 1, 2023
Study Completion (Actual)
April 3, 2023
Study Registration Dates
First Submitted
February 7, 2023
First Submitted That Met QC Criteria
March 20, 2023
First Posted (Actual)
March 31, 2023
Study Record Updates
Last Update Posted (Actual)
September 29, 2023
Last Update Submitted That Met QC Criteria
September 27, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Membrane Transport Modulators
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Lidocaine
Other Study ID Numbers
- UDDS-Pedo-03-2023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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