Ignite Creation Date:
2024-05-06 @ 4:23 PM
Last Modification Date:
2024-10-26 @ 2:08 PM
Study NCT ID:
NCT04961268
Status:
COMPLETED
Last Update Posted:
2021-07-19
First Post:
2021-07-01
Brief Title:
Effect of Preoperative Oral Tramadol on Inferior Alveolar Nerve Block in Patients With Symptomatic Irreversible Pulpitis
Sponsor:
Alfarabi Colleges
Organization:
Alfarabi Colleges
Study Overview
Official Title:
Effect of Preoperative Oral Tramadol on the Anaesthetic Efficacy of Inferior Alveolar Nerve Block in Patients With Symptomatic Irreversible Pulpitis A Prospective Randomized Double-blind Controlled Study
Status:
COMPLETED
Status Verified Date:
2021-07
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:
Aim The purpose of this prospective randomized double-blind controlled study was to compare the preoperative oral tramadol medication with ibuprofen and acetaminophen on the success of inferior alveolar nerve blocks IANB of mandibular posterior teeth in patients experiencing symptomatic irreversible pulpitis
Methodology The study included five study groups each consists of 50 patients who exhibited symptomatic irreversible pulpitis of a mandibular first or second molar The patients received identically appearing capsules containing either tramadol 50 mg tramadol 100 mg ibuprofen 600 mg ibuprofen 600 mgacetaminophen 1000 mg or placebo by mouth 60 min before the administration of an IANB Endodontic access was begun 15 min after completion of the IANB and all patients used for data analysis had profound lip numbness The IANB success was defined as no or mild pain visual analog scale recordings on pulpal access or instrumentation The data were analysed using chi-square χ2 and Kruskal-Wallis tests
Methodology The study included five study groups each consists of 50 patients who exhibited symptomatic irreversible pulpitis of a mandibular first or second molar The patients received identically appearing capsules containing either tramadol 50 mg tramadol 100 mg ibuprofen 600 mg ibuprofen 600 mgacetaminophen 1000 mg or placebo by mouth 60 min before the administration of an IANB Endodontic access was begun 15 min after completion of the IANB and all patients used for data analysis had profound lip numbness The IANB success was defined as no or mild pain visual analog scale recordings on pulpal access or instrumentation The data were analysed using chi-square χ2 and Kruskal-Wallis tests
Detailed Description:
This study was designed as a double-blind randomized placebo-controlled clinical trial This trial was carried out according to the latest update of the Declaration of Helsinki guidelines October 2013 and approved by the Vision Colleges Research Ethics Committee approval number 20-52 The patients were pre-selected to participate based on a preoperative pain scale of preliminary clinical assessment following the guidelines suggested by the CONSORT group for planning and reporting clinical trials A total of 275 adult patients were screened for participation in this study They were emergency patients of the Vision Colleges Dental Clinics and were in good health based on their medical histories and oral questioning Subjects who were less than 18 years old had a history of serious medical problems had used central nervous system depressants or any analgesic medication within the previous 6 hours were pregnant or were unable to give informed consent were all excluded from the study Finally 50 patients were enrolled in each group for a total of 250 patients
The inclusion criteria were active pain in a mandibular molar first orand the second molar prolonged response to cold testing Endo-frost Roeko Langenau Germany absence of any periapical radiolucency on periapical radiographs and a vital coronal pulp on access opening The Modified Dental Anxiety Scale assessed the level of anxiety among the patients The pain of the patients was categorized into four categories using the Heft-Parker visual analogue scale HP VAS
0 mm no pain 0-54 mm faint weak or mild 55-114 mm moderate pain 114 mm strong intense and maximum possible All patients were randomly divided using block randomisation to ensure the homogeneity of the five groups The patients were randomly given tramadol 50 mg tramadol 100 mg ibuprofen 600 mg ibuprofen 600 mgacetaminophen 1000 mg or placebo by mouth 60 min before administering IANB To blind the experiment each of the 50 patients in each group was randomly allocated a code consists of 2 letters and one number Only the random numbers identified the medications thus the patient and doctor were uninformed of which medication was given to them The medication and placebo were blinded in the following way In opaque yellow size 000 capsules a certified pharmacist prepared identical-appearing capsules of the medications and placebo in identical separate containers for each medication At 60 minutes after receiving the medication or placebo the operator used a cotton tip applicator to put anaesthetic gel 20 percent benzocaine Patterson Dental Supply Inc St Paul MN USA at the IANB injection site for 60 s
The participants were then given regular IANB injections and 09 mL long buccal injections containing 2 lidocaine and 1100000 epinephrine Xylocaine Astra Zeneca LP Dentsply York PA USA The first author used self-aspirating syringes Septodont Sant-Maur-des-Fosses Cedex France and 27-G long needles to inject the anaesthetic solution Septoject Septodont Each patient was asked for lip numbness every 5 min for 15 min after the IANB The block was considered missed if substantial lip numbness was not reported by 15 min and the participant was excluded from the trial Due to a lack of lip numbness no patients were excluded
After that a rubber dam was used to isolate the teeth and endodontic access was conducted During the endodontic process patients were asked to rate any pain they experienced If the patient was in pain the treatment was stopped and the patient used the HP VAS to rate hisher discomfort The success of the IANB was defined as the ability to access and clean and shape the tooth without pain VAS score of 0 or mild pain VAS rating 54 mm The rubber dam was removed if the patient had moderate or severe pain VAS rating 55 mm and a buccal infiltration of a cartridge containing 4 articaine with 1100000 epinephrine Septocaine Septodont was administrated buccally to the tooth that required emergency treatment After 5 min the rubber dam was replaced and endodontic access was continued The success of the buccal infiltration was defined as the ability to access and instrument the tooth without pain VAS score of 0 or with mild pain VAS rating 54 mm Intraosseous anaesthesia was administrated to the patients who still had moderate to severe pain The intraosseous injection was administrated with the Stabident intraosseous anaesthetic system Fairfax Dental Inc Miami Fl USA using a cartridge of 2 lidocaine with 1100000 epinephrine as described previously If that was not successful an intrapulpal injection was given and endodontic debridement was completed The extent of access preparation andor instrumentation was recorded as within dentine within pulp space and instrumentation of canals
The VAS satisfaction form was used to record the post-treatment satisfaction of the patient The patient was asked to draw a vertical line on the VAS 0-100 mm to indicate their satisfaction with the entire treatment The VAS was classified into four categories 0 not satisfied 0 mm and 33 mm somewhat satisfied 33 mm but 66 mm moderately satisfied and 66 mm completely satisfied
Data of the study were collected and statistically analysed SPSS 220 software IBM Corp Armonk NY USA using chi-square χ2 test to compare between different groups for anaesthetic success gender and tooth type Normality of data was tested by Shapiro-Wilk test The Modified Dental Anxiety Scale age and initial pain ratings were analysed by using Kruskal-Wallis test The level of statistical significance was set at P 005 GPower v313 software University of Düsseldorf Düsseldorf Germany was used to calculate the sample size According to a power analysis a sample size of 50 patients per group meets the constraints of 005 and power 095
The inclusion criteria were active pain in a mandibular molar first orand the second molar prolonged response to cold testing Endo-frost Roeko Langenau Germany absence of any periapical radiolucency on periapical radiographs and a vital coronal pulp on access opening The Modified Dental Anxiety Scale assessed the level of anxiety among the patients The pain of the patients was categorized into four categories using the Heft-Parker visual analogue scale HP VAS
0 mm no pain 0-54 mm faint weak or mild 55-114 mm moderate pain 114 mm strong intense and maximum possible All patients were randomly divided using block randomisation to ensure the homogeneity of the five groups The patients were randomly given tramadol 50 mg tramadol 100 mg ibuprofen 600 mg ibuprofen 600 mgacetaminophen 1000 mg or placebo by mouth 60 min before administering IANB To blind the experiment each of the 50 patients in each group was randomly allocated a code consists of 2 letters and one number Only the random numbers identified the medications thus the patient and doctor were uninformed of which medication was given to them The medication and placebo were blinded in the following way In opaque yellow size 000 capsules a certified pharmacist prepared identical-appearing capsules of the medications and placebo in identical separate containers for each medication At 60 minutes after receiving the medication or placebo the operator used a cotton tip applicator to put anaesthetic gel 20 percent benzocaine Patterson Dental Supply Inc St Paul MN USA at the IANB injection site for 60 s
The participants were then given regular IANB injections and 09 mL long buccal injections containing 2 lidocaine and 1100000 epinephrine Xylocaine Astra Zeneca LP Dentsply York PA USA The first author used self-aspirating syringes Septodont Sant-Maur-des-Fosses Cedex France and 27-G long needles to inject the anaesthetic solution Septoject Septodont Each patient was asked for lip numbness every 5 min for 15 min after the IANB The block was considered missed if substantial lip numbness was not reported by 15 min and the participant was excluded from the trial Due to a lack of lip numbness no patients were excluded
After that a rubber dam was used to isolate the teeth and endodontic access was conducted During the endodontic process patients were asked to rate any pain they experienced If the patient was in pain the treatment was stopped and the patient used the HP VAS to rate hisher discomfort The success of the IANB was defined as the ability to access and clean and shape the tooth without pain VAS score of 0 or mild pain VAS rating 54 mm The rubber dam was removed if the patient had moderate or severe pain VAS rating 55 mm and a buccal infiltration of a cartridge containing 4 articaine with 1100000 epinephrine Septocaine Septodont was administrated buccally to the tooth that required emergency treatment After 5 min the rubber dam was replaced and endodontic access was continued The success of the buccal infiltration was defined as the ability to access and instrument the tooth without pain VAS score of 0 or with mild pain VAS rating 54 mm Intraosseous anaesthesia was administrated to the patients who still had moderate to severe pain The intraosseous injection was administrated with the Stabident intraosseous anaesthetic system Fairfax Dental Inc Miami Fl USA using a cartridge of 2 lidocaine with 1100000 epinephrine as described previously If that was not successful an intrapulpal injection was given and endodontic debridement was completed The extent of access preparation andor instrumentation was recorded as within dentine within pulp space and instrumentation of canals
The VAS satisfaction form was used to record the post-treatment satisfaction of the patient The patient was asked to draw a vertical line on the VAS 0-100 mm to indicate their satisfaction with the entire treatment The VAS was classified into four categories 0 not satisfied 0 mm and 33 mm somewhat satisfied 33 mm but 66 mm moderately satisfied and 66 mm completely satisfied
Data of the study were collected and statistically analysed SPSS 220 software IBM Corp Armonk NY USA using chi-square χ2 test to compare between different groups for anaesthetic success gender and tooth type Normality of data was tested by Shapiro-Wilk test The Modified Dental Anxiety Scale age and initial pain ratings were analysed by using Kruskal-Wallis test The level of statistical significance was set at P 005 GPower v313 software University of Düsseldorf Düsseldorf Germany was used to calculate the sample size According to a power analysis a sample size of 50 patients per group meets the constraints of 005 and power 095
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