Ignite Creation Date:
2024-05-06 @ 10:27 AM
Last Modification Date:
2024-10-26 @ 12:30 PM
Study NCT ID:
NCT03262857
Status:
COMPLETED
Last Update Posted:
2019-08-12
First Post:
2017-08-19
Brief Title:
Effect of Lidocaine With Magnesium Sulfate on the Success of the Inferior Alveolar Nerve Block
Sponsor:
Isfahan University of Medical Sciences
Organization:
Isfahan University of Medical Sciences
Study Overview
Official Title:
Comparison of the Success Rate of Anesthesia Between Lidocaine 2 and Lidocaine 2 Mixed With 10 Magnesium Sulfate in the Inferior Alveolar Nerve Block in Posterior Teeth With Irreversible Pulpitis
Status:
COMPLETED
Status Verified Date:
2019-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
68 healthy patients pulpitis and requiring root canal therapy are selected Sampling was done in a simple and non-experimental way from a dental clinic in Isfahan and then the samples were randomly assigned to one of the two experimental groups A B using simple random numbers
Each vial is filled with distilled water or magnesium sulfate by an individual who is unaware of the nature of the design and is not involved in the design and each letter A or B is written This statement is not decoded after the statistical examination Therefore the study is blind and blind In this way 60 patients are examined in 2 groups of 34 First patients with recognized pulpitis in mandibular posterior teeth have been identified and information about them is given Patients will be introduced to the executive phase after the required explanation and clarification of the ambiguity and written consent After completing the patient information form by the practitioner and complying with all entry and exit criteria the study begins on each patient
The patient records his pain as an initial pain on the Heath-Parker Visual Analogue Scale VAS This pain measurement method involves a 180 mm line with descriptive words that differentiates patients on a line where the best describes their pain In order to design a standard injection of the maxillary nerve block in all patients using Aspirating Dental Injection Syringe Novocol Ontario Canada the needle of the 27 mm long 35 mm Septoject Septodont Saint-Maur-des- Fosses cedex France Lidocaine 2 with epinephrine 800001 mixed with magnesium sulfate or distilled water injections in the retro-cell region and cm1 above the occlusal mandibular plan After insertion of the needle at a rate of 3-5 mm into the tissue aspiration was performed and about 2-3 ml 2 It is injected from the contents of the cartridge the syringe 1 mm is returned to the bone hard tissue in the form of the syringe body in the perimmel area of the opposite side and after the aspiration of the contents of each cartridge in a 1 minute period It is injected After 15 minutes in case of numbness of the lips the patient begins to study and the access cavity begins on the desired tooth In each of the stages of acquiring the access cavity or entering the initial file to the canal in the event of pain the treatment is suspended and the patient signs his pain on the pain assessment chart based on the Heft-parker VAS and at this stage the study Its over In the absence of anesthetized lips the patient is excluded from the study and after completing the injection the root canal is given
Each vial is filled with distilled water or magnesium sulfate by an individual who is unaware of the nature of the design and is not involved in the design and each letter A or B is written This statement is not decoded after the statistical examination Therefore the study is blind and blind In this way 60 patients are examined in 2 groups of 34 First patients with recognized pulpitis in mandibular posterior teeth have been identified and information about them is given Patients will be introduced to the executive phase after the required explanation and clarification of the ambiguity and written consent After completing the patient information form by the practitioner and complying with all entry and exit criteria the study begins on each patient
The patient records his pain as an initial pain on the Heath-Parker Visual Analogue Scale VAS This pain measurement method involves a 180 mm line with descriptive words that differentiates patients on a line where the best describes their pain In order to design a standard injection of the maxillary nerve block in all patients using Aspirating Dental Injection Syringe Novocol Ontario Canada the needle of the 27 mm long 35 mm Septoject Septodont Saint-Maur-des- Fosses cedex France Lidocaine 2 with epinephrine 800001 mixed with magnesium sulfate or distilled water injections in the retro-cell region and cm1 above the occlusal mandibular plan After insertion of the needle at a rate of 3-5 mm into the tissue aspiration was performed and about 2-3 ml 2 It is injected from the contents of the cartridge the syringe 1 mm is returned to the bone hard tissue in the form of the syringe body in the perimmel area of the opposite side and after the aspiration of the contents of each cartridge in a 1 minute period It is injected After 15 minutes in case of numbness of the lips the patient begins to study and the access cavity begins on the desired tooth In each of the stages of acquiring the access cavity or entering the initial file to the canal in the event of pain the treatment is suspended and the patient signs his pain on the pain assessment chart based on the Heft-parker VAS and at this stage the study Its over In the absence of anesthetized lips the patient is excluded from the study and after completing the injection the root canal is given
Detailed Description:
68 healthy patients ASA I II and over the age of 18 and under the age of 60 years with posterior mandibular maxillary jaw and with symptomatic pulpitis severe and long response to cold test and requiring root canal therapy are selected
The criteria for entering the study include absence of periodontal disease and any periapical radiolucency except for PDL dilation absence of susceptibility to local anesthetic or sulfite drugs non-pregnant women and non-lactating women lack of drugs that interact with local anesthetic Or change the perception of pain such as beta-blocker drugs opiates etc
Exclusion criteria included Clinical observation of necrotic pulp after opening the access cavity in the desired tooth the patients inability to give informed consent and patients continuation of the research in each stage of the trial
Sampling was done in a simple and non-experimental way from a dental clinic in Isfahan and then the samples were randomly assigned to one of the two experimental groups A B using simple random numbers
Preparation of infiltration solution will be such that using a syringe with a high accuracy hamilton of 02 ml of magnesium 10 sulfate vial or distilled water sterilized and then into a 18ml cartridge of lidocaine 2 With an epinephrine 800001 the solution is shaken 5 times for mixing so that no sediment should be seen
Each vial is filled with distilled water or magnesium sulfate by an individual who is unaware of the nature of the design and is not involved in the design and each letter A or B is written This statement is not decoded after the statistical examination Therefore the study is blind and blind In this way 68 patients are examined in 2 groups of 34 people It should be noted that all anesthesia is injected by one person
First patients with recognized pulpitis in mandibular posterior teeth have been identified and information about them is given Patients will be introduced to the executive phase after the required explanation and clarification of the ambiguity and written consent After completing the patient information form by the practitioner and complying with all entry and exit criteria the study begins on each patient
The patient records his pain as an initial pain on the Heath-Parker Visual Analogue Scale VAS This pain measurement method involves a 180 mm line with descriptive words that differentiates patients on a line where the best describes their pain In order to design a standard injection of the maxillary nerve block in all patients using Aspirating Dental Injection Syringe Novocol Ontario Canada the needle of the 27 mm long 35 mm Septoject Septodont Saint-Maur-des- Fosses cedex France Lidocaine 2 with epinephrine 800001 mixed with magnesium sulfate or distilled water injections in the retro-cell region and cm1 above the occlusal mandibular plan After insertion of the needle at a rate of 3-5 mm into the tissue aspiration was performed and about 2-3 ml 2 It is injected from the contents of the cartridge the syringe 1 mm is returned to the bone hard tissue in the form of the syringe body in the perimmel area of the opposite side and after the aspiration of the contents of each cartridge in a 1 minute period It is injected After 15 minutes in case of numbness of the lips the patient begins to study and the access cavity begins on the desired tooth In each of the stages of acquiring the access cavity or entering the initial file to the canal in the event of pain the treatment is suspended and the patient signs his pain on the pain assessment chart based on the Heft-parker VAS and at this stage the study Its over In the absence of anesthetized lips the patient is excluded from the study and after completing the injection the root canal is given
The criteria for entering the study include absence of periodontal disease and any periapical radiolucency except for PDL dilation absence of susceptibility to local anesthetic or sulfite drugs non-pregnant women and non-lactating women lack of drugs that interact with local anesthetic Or change the perception of pain such as beta-blocker drugs opiates etc
Exclusion criteria included Clinical observation of necrotic pulp after opening the access cavity in the desired tooth the patients inability to give informed consent and patients continuation of the research in each stage of the trial
Sampling was done in a simple and non-experimental way from a dental clinic in Isfahan and then the samples were randomly assigned to one of the two experimental groups A B using simple random numbers
Preparation of infiltration solution will be such that using a syringe with a high accuracy hamilton of 02 ml of magnesium 10 sulfate vial or distilled water sterilized and then into a 18ml cartridge of lidocaine 2 With an epinephrine 800001 the solution is shaken 5 times for mixing so that no sediment should be seen
Each vial is filled with distilled water or magnesium sulfate by an individual who is unaware of the nature of the design and is not involved in the design and each letter A or B is written This statement is not decoded after the statistical examination Therefore the study is blind and blind In this way 68 patients are examined in 2 groups of 34 people It should be noted that all anesthesia is injected by one person
First patients with recognized pulpitis in mandibular posterior teeth have been identified and information about them is given Patients will be introduced to the executive phase after the required explanation and clarification of the ambiguity and written consent After completing the patient information form by the practitioner and complying with all entry and exit criteria the study begins on each patient
The patient records his pain as an initial pain on the Heath-Parker Visual Analogue Scale VAS This pain measurement method involves a 180 mm line with descriptive words that differentiates patients on a line where the best describes their pain In order to design a standard injection of the maxillary nerve block in all patients using Aspirating Dental Injection Syringe Novocol Ontario Canada the needle of the 27 mm long 35 mm Septoject Septodont Saint-Maur-des- Fosses cedex France Lidocaine 2 with epinephrine 800001 mixed with magnesium sulfate or distilled water injections in the retro-cell region and cm1 above the occlusal mandibular plan After insertion of the needle at a rate of 3-5 mm into the tissue aspiration was performed and about 2-3 ml 2 It is injected from the contents of the cartridge the syringe 1 mm is returned to the bone hard tissue in the form of the syringe body in the perimmel area of the opposite side and after the aspiration of the contents of each cartridge in a 1 minute period It is injected After 15 minutes in case of numbness of the lips the patient begins to study and the access cavity begins on the desired tooth In each of the stages of acquiring the access cavity or entering the initial file to the canal in the event of pain the treatment is suspended and the patient signs his pain on the pain assessment chart based on the Heft-parker VAS and at this stage the study Its over In the absence of anesthetized lips the patient is excluded from the study and after completing the injection the root canal is given
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None