Symptomatic Irreversible PulpitisNCT04961268
Effect of Preoperative Oral Tramadol on Inferior Alveolar Nerve Block in Patients With Symptomatic Irreversible Pulpitis
A study testing TraMADol 50 Mg Oral Tablet, Tramadol 100 MG Oral Tablet and Ibuprofen 600Mg Tab in people with Symptomatic Irreversible Pulpitis, run by Alfarabi Colleges at 1 site in Saudi Arabia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Symptomatic Irreversible Pulpitis
- What is being tested?
- TraMADol 50 Mg Oral Tablet, Tramadol 100 MG Oral Tablet and Ibuprofen 600Mg Tab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Jun 2020to 28 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- active pain in a mandibular molar first or/and the second molar
- prolonged response to cold testing
- absence of any periapical radiolucency on periapical radiographs
- vital coronal pulp on access opening
- able to give informed consent
Who cannot join
- less than 18 years old
- history of serious medical problems
- used central nervous system depressants or any analgesic medication within the previous 6 hours
- pregnancy
- inability to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
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
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 mg/acetaminophen 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.
Read the 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 20-5/2). 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 or/and 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 mg/acetaminophen 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 0.9 mL long buccal injections containing 2% lidocaine and 1:100,000 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 his/her 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 1:100,000 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 1:100,000 epinephrine as described previously. If that was not successful, an intrapulpal injection was given, and endodontic debridement was completed. The extent of access preparation and/or 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 22.0 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 < 0.05. GPower v3.1.3 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 0.05 and power = 0.95.
- Conditions
- Symptomatic Irreversible Pulpitis
- Being tested
- TraMADol 50 Mg Oral Tablet, Tramadol 100 MG Oral Tablet, Ibuprofen 600Mg Tab, ibuprofen 600 mg/acetaminophen 1000 mg, Placebo
- Keywords
- anaesthesia, endodontics, inferior alveolar nerve block, NSAIDs, tramadol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TraMADol 50 Mg Oral TabletDrug
Also called TRAMAL
The patients were randomly given the medication by mouth 60 min before administering IANB.
Tramadol 100 MG Oral TabletDrug
Also called TRAMAL
The patients were randomly given the medication by mouth 60 min before administering IANB.
Ibuprofen 600Mg TabDrug
Also called IBUPROFEN
The patients were randomly given the medication by mouth 60 min before administering IANB.
ibuprofen 600 mg/acetaminophen 1000 mgDrug
Also called IBUPROFEN/PANADOL
The patients were randomly given the medication by mouth 60 min before administering IANB.
PlaceboDrug
The patients were randomly given the medication by mouth 60 min before administering IANB.
| Study group | Role | What they receive |
|---|---|---|
| Tramadol 50 | Active comparator | Before the inferior alveolar nerve block injection by 60 minutes, the patient received tramadol 50 mg in opaque yellow size "000" capsules. Receives: Drug: TraMADol 50 Mg Oral Tablet |
| Tramadol 100 | Active comparator | Before the inferior alveolar nerve block injection by 60 minutes, the patient received tramadol 100 mg in opaque yellow size "000" capsules. Receives: Drug: Tramadol 100 MG Oral Tablet |
| Ibuprofen | Active comparator | Before the inferior alveolar nerve block injection by 60 minutes, the patient received ibuprofen 600 mg in opaque yellow size "000" capsules. Receives: Drug: Ibuprofen 600Mg Tab |
| Ibuprofen/acetaminophen | Active comparator | Before the inferior alveolar nerve block injection by 60 minutes, the patient received ibuprofen 600 mg/acetaminophen 1000 mg in opaque yellow size "000" capsules. Receives: Drug: ibuprofen 600 mg/acetaminophen 1000 mg |
| Placebo | Placebo comparator | Before the inferior alveolar nerve block injection by 60 minutes, the patient received Placebo in opaque yellow size "000" capsules. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Measurement as Assessed on a Heft-Parker 170 mm Visual Analog Scale
At 60 minutes after receiving the medication or placebo, the participants were then given inferior alveolar nerve block injection. Each patient was asked for lip numbness every 5 minutes for 15 minutes after inferior alveolar nerve block injection. During the endodontic process, patients were asked to rate any pain they experienced on a Heft-Parker visual analog scale. The number of millimeters along the scale were reported. No pain corresponded to 0 mm. Mild pain was defined as greater than 0 mm and less than or equal to 54 mm. Mild pain included the descriptors of "faint", "weak", and "mild pain". Moderate pain was defined as greater than 54 mm and less than 114 mm and included the descriptor "moderate". Severe pain was defined as equal to or greater than 114 mm up to and including 170 mm. Severe pain included the descriptors of "strong", "intense", and "maximum possible."
Measured: 15 minutes after the inferior alveolar nerve block.
Secondary outcomes (1)
Postoperative Satisfaction on a 100 mm Visual Analog Scale
Patients were rate their level of satisfaction after treatment procedure using a visual analog scale. The scale ranges from "not satisfied," to "somewhat satisfied," to "moderately satisfied," to "completely satisfied." Not satisfied corresponded to 0 mm. Somewhat satisfied was defined as greater than 0 mm and less than or equal to 33 mm. Moderately satisfied was defined as greater than 33 mm and less than 66 mm. Completely satisfied was defined as equal to or greater than 66 mm.
Measured: Immediately post-procedure on Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2021
- Study start1 Jun 2020
- Primary completion28 Feb 2021
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Symptomatic Irreversible PulpitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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 mg/acetaminophen 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alfarabi Colleges
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Elnaghy, Alfarabi Colleges
- Investigators
- Amr M Elnaghy, PhD, Principal investigator, Associate Professor of Endodontics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04961268
- Sponsor's protocol ID
- Alfarabi
- Status last verified
- Jul 2021
- First submitted
- 1 Jul 2021
- Last updated
- 19 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this study, after deidentification (text, tables, and figures).
Publications
Argueta-Figueroa L, Arzate-Sosa G, Mendieta-Zeron H. Anesthetic efficacy of articaine for inferior alveolar nerve blocks in patients with symptomatic versus asymptomatic irreversible pulpitis. Gen Dent. 2012 Jan-Feb;60(1):e39-43.
PubMed 22313992Pulikkotil SJ, Nagendrababu V, Veettil SK, Jinatongthai P, Setzer FC. Effect of oral premedication on the anaesthetic efficacy of inferior alveolar nerve block in patients with irreversible pulpitis - A systematic review and network meta-analysis of randomized controlled trials. Int Endod J. 2018 Sep;51(9):989-1004. doi: 10.1111/iej.12912. Epub 2018 Mar 24.
PubMed 29480930Aggarwal V, Singla M, Kabi D. Comparative evaluation of effect of preoperative oral medication of ibuprofen and ketorolac on anesthetic efficacy of inferior alveolar nerve block with lidocaine in patients with irreversible pulpitis: a prospective, double-blind, randomized clinical trial. J Endod. 2010 Mar;36(3):375-8. doi: 10.1016/j.joen.2009.11.010.
PubMed 20171350Aggarwal V, Singla M, Miglani S. Comparative Evaluation of Anesthetic Efficacy of 2% Lidocaine, 4% Articaine, and 0.5% Bupivacaine on Inferior Alveolar Nerve Block in Patients with Symptomatic Irreversible Pulpitis: A Prospective, Randomized, Double-blind Clinical Trial. J Oral Facial Pain Headache. 2017 Spring;31(2):124-128. doi: 10.11607/ofph.1642.
PubMed 28437508Fowler S, Drum M, Reader A, Beck M. Anesthetic Success of an Inferior Alveolar Nerve Block and Supplemental Articaine Buccal Infiltration for Molars and Premolars in Patients with Symptomatic Irreversible Pulpitis. J Endod. 2016 Mar;42(3):390-2. doi: 10.1016/j.joen.2015.12.025. Epub 2016 Jan 28.
PubMed 26831048Yadav M, Grewal MS, Grewal S, Deshwal P. Comparison of Preoperative Oral Ketorolac on Anesthetic Efficacy of Inferior Alveolar Nerve Block and Buccal and Lingual Infiltration with Articaine and Lidocaine in Patients with Irreversible Pulpitis: A Prospective, Randomized, Controlled, Double-blind Study. J Endod. 2015 Nov;41(11):1773-7. doi: 10.1016/j.joen.2015.06.008. Epub 2015 Sep 26.
PubMed 26410153Lapidus D, Goldberg J, Hobbs EH, Ram S, Clark GT, Enciso R. Effect of premedication to provide analgesia as a supplement to inferior alveolar nerve block in patients with irreversible pulpitis. J Am Dent Assoc. 2016 Jun;147(6):427-37. doi: 10.1016/j.adaj.2016.01.006. Epub 2016 Mar 4.
PubMed 26952243Rogers BS, Botero TM, McDonald NJ, Gardner RJ, Peters MC. Efficacy of articaine versus lidocaine as a supplemental buccal infiltration in mandibular molars with irreversible pulpitis: a prospective, randomized, double-blind study. J Endod. 2014 Jun;40(6):753-8. doi: 10.1016/j.joen.2013.12.022. Epub 2014 Feb 8.
PubMed 24862701Fullmer S, Drum M, Reader A, Nusstein J, Beck M. Effect of preoperative acetaminophen/hydrocodone on the efficacy of the inferior alveolar nerve block in patients with symptomatic irreversible pulpitis: a prospective, randomized, double-blind, placebo-controlled study. J Endod. 2014 Jan;40(1):1-5. doi: 10.1016/j.joen.2013.09.009. Epub 2013 Oct 27.
PubMed 24331983
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04961268
- Acronym / sponsor ID
- Alfarabi
- Conditions
- Symptomatic Irreversible Pulpitis
- Keywords
- anaesthesia, endodontics, inferior alveolar nerve block, NSAIDs, tramadol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Alfarabi CollegesUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 14 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 mg/acetaminophen 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 20-5/2). 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 or/and 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 mg/acetaminophen 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 0.9 mL long buccal injections containing 2% lidocaine and 1:100,000 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 his/her 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 1:100,000 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 1:100,000 epinephrine as described previously. If that was not successful, an intrapulpal injection was given, and endodontic debridement was completed. The extent of access preparation and/or 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 22.0 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 < 0.05. GPower v3.1.3 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 0.05 and power = 0.95.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
- Model description
- 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 mg/acetaminophen 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.
| Arm | Type | Receives |
|---|---|---|
| Tramadol 50 | Active comparator | Drug: TraMADol 50 Mg Oral TabletBefore the inferior alveolar nerve block injection by 60 minutes, the patient received tramadol 50 mg in opaque yellow size "000" capsules. |
| Tramadol 100 | Active comparator | Drug: Tramadol 100 MG Oral TabletBefore the inferior alveolar nerve block injection by 60 minutes, the patient received tramadol 100 mg in opaque yellow size "000" capsules. |
| Ibuprofen | Active comparator | Drug: Ibuprofen 600Mg TabBefore the inferior alveolar nerve block injection by 60 minutes, the patient received ibuprofen 600 mg in opaque yellow size "000" capsules. |
| Ibuprofen/acetaminophen | Active comparator | Drug: ibuprofen 600 mg/acetaminophen 1000 mgBefore the inferior alveolar nerve block injection by 60 minutes, the patient received ibuprofen 600 mg/acetaminophen 1000 mg in opaque yellow size "000" capsules. |
| Placebo | Placebo comparator | Drug: PlaceboBefore the inferior alveolar nerve block injection by 60 minutes, the patient received Placebo in opaque yellow size "000" capsules. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- active pain in a mandibular molar first or/and the second molar
- prolonged response to cold testing
- absence of any periapical radiolucency on periapical radiographs
- vital coronal pulp on access opening
- able to give informed consent
Key exclusion criteria (5 listed)
- less than 18 years old
- history of serious medical problems
- used central nervous system depressants or any analgesic medication within the previous 6 hours
- pregnancy
- inability to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TraMADol 50 Mg Oral TabletAlso: TRAMALThe patients were randomly given the medication by mouth 60 min before administering IANB. | Drug | Tramadol 50 |
| Tramadol 100 MG Oral TabletAlso: TRAMALThe patients were randomly given the medication by mouth 60 min before administering IANB. | Drug | Tramadol 100 |
| Ibuprofen 600Mg TabAlso: IBUPROFENThe patients were randomly given the medication by mouth 60 min before administering IANB. | Drug | Ibuprofen |
| ibuprofen 600 mg/acetaminophen 1000 mgAlso: IBUPROFEN/PANADOLThe patients were randomly given the medication by mouth 60 min before administering IANB. | Drug | Ibuprofen/acetaminophen |
| PlaceboThe patients were randomly given the medication by mouth 60 min before administering IANB. | Drug | Placebo |
Primary outcome
Pain Measurement as Assessed on a Heft-Parker 170 mm Visual Analog Scale
Time frame: 15 minutes after the inferior alveolar nerve block.
At 60 minutes after receiving the medication or placebo, the participants were then given inferior alveolar nerve block injection. Each patient was asked for lip numbness every 5 minutes for 15 minutes after inferior alveolar nerve block injection. During the endodontic process, patients were asked to rate any pain they experienced on a Heft-Parker visual analog scale. The number of millimeters along the scale were reported. No pain corresponded to 0 mm. Mild pain was defined as greater than 0 mm and less than or equal to 54 mm. Mild pain included the descriptors of "faint", "weak", and "mild pain". Moderate pain was defined as greater than 54 mm and less than 114 mm and included the descriptor "moderate". Severe pain was defined as equal to or greater than 114 mm up to and including 170 mm. Severe pain included the descriptors of "strong", "intense", and "maximum possible."
1 secondary outcome
Postoperative Satisfaction on a 100 mm Visual Analog Scale
Time frame: Immediately post-procedure on Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2021.
- Background: PubMed 22313992Argueta-Figueroa L, Arzate-Sosa G, Mendieta-Zeron H. Anesthetic efficacy of articaine for inferior alveolar nerve blocks in patients with symptomatic versus asymptomatic irreversible pulpitis. Gen Dent. 2012 Jan-Feb;60(1):e39-43.
- Background: PubMed 29480930Pulikkotil SJ, Nagendrababu V, Veettil SK, Jinatongthai P, Setzer FC. Effect of oral premedication on the anaesthetic efficacy of inferior alveolar nerve block in patients with irreversible pulpitis - A systematic review and network meta-analysis of randomized controlled trials. Int Endod J. 2018 Sep;51(9):989-1004. doi: 10.1111/iej.12912. Epub 2018 Mar 24.
- Background: PubMed 20171350Aggarwal V, Singla M, Kabi D. Comparative evaluation of effect of preoperative oral medication of ibuprofen and ketorolac on anesthetic efficacy of inferior alveolar nerve block with lidocaine in patients with irreversible pulpitis: a prospective, double-blind, randomized clinical trial. J Endod. 2010 Mar;36(3):375-8. doi: 10.1016/j.joen.2009.11.010.
- Background: PubMed 28437508Aggarwal V, Singla M, Miglani S. Comparative Evaluation of Anesthetic Efficacy of 2% Lidocaine, 4% Articaine, and 0.5% Bupivacaine on Inferior Alveolar Nerve Block in Patients with Symptomatic Irreversible Pulpitis: A Prospective, Randomized, Double-blind Clinical Trial. J Oral Facial Pain Headache. 2017 Spring;31(2):124-128. doi: 10.11607/ofph.1642.
- Background: PubMed 26831048Fowler S, Drum M, Reader A, Beck M. Anesthetic Success of an Inferior Alveolar Nerve Block and Supplemental Articaine Buccal Infiltration for Molars and Premolars in Patients with Symptomatic Irreversible Pulpitis. J Endod. 2016 Mar;42(3):390-2. doi: 10.1016/j.joen.2015.12.025. Epub 2016 Jan 28.
- Background: PubMed 26410153Yadav M, Grewal MS, Grewal S, Deshwal P. Comparison of Preoperative Oral Ketorolac on Anesthetic Efficacy of Inferior Alveolar Nerve Block and Buccal and Lingual Infiltration with Articaine and Lidocaine in Patients with Irreversible Pulpitis: A Prospective, Randomized, Controlled, Double-blind Study. J Endod. 2015 Nov;41(11):1773-7. doi: 10.1016/j.joen.2015.06.008. Epub 2015 Sep 26.
- Background: PubMed 26952243Lapidus D, Goldberg J, Hobbs EH, Ram S, Clark GT, Enciso R. Effect of premedication to provide analgesia as a supplement to inferior alveolar nerve block in patients with irreversible pulpitis. J Am Dent Assoc. 2016 Jun;147(6):427-37. doi: 10.1016/j.adaj.2016.01.006. Epub 2016 Mar 4.
- Background: PubMed 24862701Rogers BS, Botero TM, McDonald NJ, Gardner RJ, Peters MC. Efficacy of articaine versus lidocaine as a supplemental buccal infiltration in mandibular molars with irreversible pulpitis: a prospective, randomized, double-blind study. J Endod. 2014 Jun;40(6):753-8. doi: 10.1016/j.joen.2013.12.022. Epub 2014 Feb 8.
- Background: PubMed 24331983Fullmer S, Drum M, Reader A, Nusstein J, Beck M. Effect of preoperative acetaminophen/hydrocodone on the efficacy of the inferior alveolar nerve block in patients with symptomatic irreversible pulpitis: a prospective, randomized, double-blind, placebo-controlled study. J Endod. 2014 Jan;40(1):1-5. doi: 10.1016/j.joen.2013.09.009. Epub 2013 Oct 27.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this study, after deidentification (text, tables, and figures).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amr M Elnaghy, PhD principal investigator
Associate Professor of Endodontics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TraMADol 50 Mg Oral Tablet, Tramadol 100 MG Oral Tablet and Ibuprofen 600Mg Tab in people with Symptomatic Irreversible Pulpitis, run by Alfarabi Colleges at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Measurement as Assessed on a Heft-Parker 170 mm Visual Analog Scale (time frame: 15 minutes after the inferior alveolar nerve block.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04961268, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2021.