Protocol summary
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Study aim
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To compare the efficacy of buffered local anesthetic with non-buffered local anesthetic in terms of pain reduction and speed of onset of anesthesia.
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Design
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It was a randomized, parallel group, double blinded, single center study including 100 patients in total.
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Settings and conduct
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This randomized controlled trial was conducted at Armed Forces Institute of Dentistry in the outpatient department of Oral & Maxillofacial Surgery from March 2020 to Dec 2022.
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Participants/Inclusion and exclusion criteria
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The physical condition of all patients was evaluated, and those with systemic diseases for which injections of lignocaine with adrenaline were contraindicated, were excluded from the study.
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Intervention groups
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The study included a total of 140 TMD patients that were randomly assigned to two groups: Buffered Group (A) (n=50) and Non- Buffered Group or Control Group (B) (n=50). Buffered local anesthesia was made by adding 0.18 ml of 8.4% solution of sodium bicarbonate to a 1.8ml cartridge of 2% Lignocaine with adrenaline 1:100,000 leading to a 1:10 dilution. All procedures were done by a single maxillofacial surgeon, who was unaware of the type of LA given to the patient.
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Main outcome variables
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Pain intensity was assessed using the Visual Analog Scale (VAS) and speed of onset of anesthesia measured in seconds from point of retrieval of the needle.
General information
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Reason for update
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The dates have been updated.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20230622058557N2
Registration date:
2023-07-04, 1402/04/13
Registration timing:
retrospective
Last update:
2023-12-20, 1402/09/29
Update count:
1
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Registration date
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2023-07-04, 1402/04/13
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-03-11, 1397/12/20
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Expected recruitment end date
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2023-01-31, 1401/11/11
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Actual recruitment start date
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2019-08-01, 1398/05/10
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Actual recruitment end date
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2023-03-31, 1402/01/11
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Trial completion date
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2023-04-30, 1402/02/10
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Scientific title
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Comparison of buffered with standard local anesthetics in odontogenic infections: a randomized controlled trial
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Public title
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Effect of buffered anesthetics in odontogenic infections
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patient between 18 to 70 years that have Odontogenic maxillofacial infection surrounding any tooth.
Lack of sensitivity to local anesthetics
Patients having acute abscess of any tooth
Patients having acute periapical periodontitis leading to granuloma formation
Patients having physical status 1 and 2 according to American Society of Anesthesiologists(ASA) classification
Exclusion criteria:
Patients with systemic diseases for which injections of lignocaine with adrenaline are contraindicated will be excluded from the study
Anesthesia allergy or drug abuse history
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Age
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From 18 years old to 70 years old
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Gender
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Both
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Phase
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4
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Groups that have been masked
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Sample size
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Target sample size:
70
Actual sample size reached:
100
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization was performed using a sealed envelope with a computer-generated random allocation for each patient. According to the this, patients were randomly divided to receive either be in the Buffered Group (A) or Non Buffered Group (B).
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Double-blind fashion technique was used in which the patient is unaware of the type of anesthetic being administered to them , buffered or standard and the Doctor administering the local anesthesia doesn't know if the cartridge has been buffered or not. It was prepared by another researcher and handed to the doctor administering the injection.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-03-09, 1398/12/19
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Ethics committee reference number
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Ref:905/Trg-ABP1K3
Health conditions studied
1
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Description of health condition studied
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Odontogenic Infection: Defined as inflammation originating within a tooth or closely related to the surrounding structures presenting as periapical inflammation in the form of acute periapical periodontitis or a periapical abscess with or without extensions into adjacent facial planes.
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ICD-10 code
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K04.7
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ICD-10 code description
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Periapical abscess without sinus
2
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Description of health condition studied
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Odontogenic Infection: Defined as inflammation originating within a tooth or closely related to the surrounding structures presenting as periapical inflammation in the form of acute periapical periodontitis or a periapical abscess with or without extensions into adjacent facial planes.
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ICD-10 code
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K04.4
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ICD-10 code description
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Acute apical periodontitis of pulpal origin
Primary outcomes
1
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Description
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Pain Assessment: Pain will be determined by the patient before and after injection using VAS Pain score. It is a 10 cm long scale with 0 marking indicating no pain to 10 marking as worst pain possible.
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Timepoint
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Before and immediately after local anesthetic injection.
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Method of measurement
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Visual Analog Pain Score
2
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Description
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Efficacy of Anesthesia: Determined by the onset of anesthesia i.e. the first feeling of numbness in the region of the teeth anaesthetized checked by inserting straight probe in the gingival sulcus of the involved region.
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Timepoint
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Immediately after injection is administered with 30 seconds intervals .
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Method of measurement
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Seconds
Intervention groups
1
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Description
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Intervention group: Group A. This group received buffered local anesthesia by adding 0.18 ml of 8.4 percent sodium bicarbonate solution to 1.8ml 2 % Lignocaine with 1:100,000 adrenaline cartridge immediately before injecting.
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Category
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Treatment - Drugs
2
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Description
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Intervention group: Group B. This group will receive standard 2 % Lignocaine with 1:100,000 adrenaline cartridge that has not been buffered.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Armed Forces Institute of Dentistry
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Proportion provided by this source
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100
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Other
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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It is the organization's policy to not share IPD
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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The data is entered in SPSS Software.
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When the data will become available and for how long
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6 months after publication for a period of 3 months.
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To whom data/document is available
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To Medical and Dental Academic Institutes.
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Under which criteria data/document could be used
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Academic professionals studying in Medical & Dental Institutes.
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From where data/document is obtainable
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Email to Investigator.
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What processes are involved for a request to access data/document
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Email to Investigator.
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Comments
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