Symptomatic Irreversible PulpitisNCT05097768
Effectiveness of Premedication on the Success Rate of Inferior Alveolar Nerve Block
A study testing Dexamethasone 0.5mg, Ketorolac 10 Mg Oral Tablet and Meloxicam 7.5 mg in people with Symptomatic Irreversible Pulpitis, run by Alfarabi Colleges at 1 site in Saudi Arabia.
Trial summary
Purpose: The aim of this prospective, double-blind, randomized controlled trial is to compare the effect of oral premedication of dexamethasone, ketorolac, meloxicam, ibuprofen or placebo on the success of inferior alveolar nerve blocks (IANB) of mandibular posterior teeth in patients experiencing symptomatic… 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?
- Dexamethasone 0.5mg, Ketorolac 10 Mg Oral Tablet and Meloxicam 7.5 mg
- 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
- 15 Aug 2021to 27 Jan 2022
- 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: Effectiveness of Oral Premedication on the Success Rate of Inferior Alveolar Nerve Block in Patients With Symptomatic Irreversible Pulpitis: A Prospective, Double-blind, Randomized Controlled Trial
Purpose: The aim of this prospective, double-blind, randomized controlled trial is to compare the effect of oral premedication of dexamethasone, ketorolac, meloxicam, ibuprofen or placebo on the success of inferior alveolar nerve blocks (IANB) of mandibular posterior teeth in patients experiencing symptomatic irreversible pulpitis. Methods: The trial will include five study groups, each consists of 50 patients who exhibits symptomatic irreversible pulpitis of a mandibular first or second molar. The patients will receive identically appearing capsules containing either dexamethasone 0.5 mg, ketorolac 10 mg, meloxicam 7.5 mg, ibuprofen 600 mg, or placebo by mouth 60 minutes before the administration of an IANB. Endodontic access will begin 15 minutes after completion of the IANB. The IANB success is defined as no or mild pain (Heft Parker visual analog scale recordings) on pulpal access or instrumentation.
Read the detailed description
This study is designed as a randomized, double-blind, placebo-controlled trial. This trial follows the most recent update of the Declaration of Helsinki criteria (October 2013). The Vision Colleges Research Ethics Committee approved the clinical trial protocol and informed consent. The Consolidated Standards of Reporting Trials guidelines will be used to report the present superiority study. Participants under the age of 18, those with a history of major medical issues, those who had used central nervous system depressants or any analgesic drug in the preceding 6 h, those who were pregnant, and those who were unable to give informed consent will be excluded from the study. All the patients will sign a consent form that had been approved.
The inclusion criteria will be active pain in the first or second mandibular molar, a prolonged response to cold testing, no periapical radiolucency on periapical radiographs, and a vital coronal pulp on access opening. The Modified Dental Anxiety Scale will be used to assess the patients' anxiety levels. The pain of the patients will be 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 Permuted block randomization will be used to ensure the homogeneity of the five groups. The patients will be randomly given dexamethasone 0.5 mg, ketorolac 10 mg, meloxicam 7.5 mg, ibuprofen 600 mg, or placebo by mouth 60 mins before administering IANB. To blind the experiment, each of the 50 patients in each group will be randomly allocated a code consists of 2 letters and one number. Only the random codes will identify the medications; thus, the patient and clinicians are uninformed of which medication will be given to them. At 60 mins after taking the medication or placebo, the operator will use a cotton tip applicator to put anaesthetic gel at the IANB injection site for 60 s.
The participants will then give regular IANB injections and 0.9 mL long buccal injections containing 2% lidocaine and 1:100,000 epinephrine. Each patient will be asked for lip numbness every 5 mins for 15 mins after the IANB. The block will be considered missed if substantial lip numbness was not reported by 15 mins, and the participant will be excluded from the trial. After the lip numbness is determined, the tooth will be isolated and a second cold test will be performed to verify the presence or absence of any painful reaction.
After that, the endodontic access will be conducted. During the endodontic process, patients will be asked to rate any pain they experienced. If the patient is in pain, the treatment will be stopped, and the patient will use the HP VAS to rate his/her discomfort. The success of the IANB is identified by the capability to access and clean and shape the root canal space without pain (VAS score of 0) or mild pain (VAS rating ≤54 mm). The rubber dam will be removed if the patient had moderate or severe pain (VAS rating ≥ 55 mm). Then, a buccal infiltration of a cartridge containing 4% articaine with 1:100,000 epinephrine will be given buccally to the tooth that required emergency treatment. After 5 mins, the rubber dam will be replaced, and endodontic access will be resumed. The capability to access and instrument the tooth without pain (VAS score of 0) or with mild pain (VAS rating ≤54 mm) is considered a success of the buccal infiltration. Intraosseous anesthesia will be given to the patients who still had moderate to severe pain. The intraosseous injection will be given. If that didn't work, an intrapulpal injection will be given, followed by endodontic debridement. The extent of access preparation and/or instrumentation will be recorded as within dentine, within pulp space, and instrumentation of canals.
The VAS satisfaction form will be used to record the post-treatment satisfaction of the patient. On the VAS (0-100 mm), the patient will be asked to draw a vertical line to represent their experience with the entire treatment. The VAS is 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.
- Conditions
- Symptomatic Irreversible Pulpitis
- Being tested
- Dexamethasone 0.5mg, Ketorolac 10 Mg Oral Tablet, Meloxicam 7.5 mg, Ibuprofen 600 mg, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone 0.5mgDrug
The patients will be randomly given the medication by mouth 60 min before administering IANB.
Ketorolac 10 Mg Oral TabletDrug
The patients will be randomly given the medication by mouth 60 min before administering IANB.
Meloxicam 7.5 mgDrug
The patients will be randomly given the medication by mouth 60 min before administering IANB.
Ibuprofen 600 mgDrug
The patients will be randomly given the medication by mouth 60 min before administering IANB.
PlaceboDrug
The patients will be randomly given the medication by mouth 60 min before administering IANB.
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone | Active comparator | Before the inferior alveolar nerve block injection by 60 minutes, the patient will receive Dexamethasone 0.5 mg. Receives: Drug: Dexamethasone 0.5mg |
| Ketorolac | Active comparator | Before the inferior alveolar nerve block injection by 60 minutes, the patient will receive ketorolac 10 mg. Receives: Drug: Ketorolac 10 Mg Oral Tablet |
| Meloxicam | Active comparator | Before the inferior alveolar nerve block injection by 60 minutes, the patient will receive meloxicam 7.5 mg. Receives: Drug: Meloxicam 7.5 mg |
| Ibuprofen | Active comparator | Before the inferior alveolar nerve block injection by 60 minutes, the patient will receive ibuprofen 600 mg. Receives: Drug: Ibuprofen 600 mg |
| Placebo | Placebo comparator | Before the inferior alveolar nerve block injection by 60 minutes, the patient will receive placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Measurement as it will be assessed on a Heft-Parker 170 mm Visual Analog Scale
At 60 minutes after receiving the medication or placebo, the participants will be given inferior alveolar nerve block injection. Each patient will be asked for lip numbness every 5 minutes for 15 minutes after inferior alveolar nerve block injection. During the endodontic process, patients will be asked to rate any pain they experienced on a Heft-Parker visual analog scale. The number of millimeters along the scale will be reported. No pain corresponded to 0 mm. Mild pain is defined as greater than 0 mm and less than or equal to 54 mm. Mild pain is the descriptors of "faint", "weak", and "mild pain". Moderate pain is defined as greater than 54 mm and less than 114 mm and includes the descriptor "moderate". Severe pain is defined as equal to or greater than 114 mm up to and including 170 mm. Severe pain includes 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 will 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 is defined as greater than 0 mm and less than or equal to 33 mm. Moderately satisfied is defined as greater than 33 mm and less than 66 mm. Completely satisfied is 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 posted28 Oct 2021
- Study start15 Aug 2021
- Primary completion15 Jan 2022
- Study completion27 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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 trial will include five study groups, each consists of 50 patients who exhibits symptomatic irreversible pulpitis of a mandibular first or second molar. The patients will receive identically appearing capsules containing either dexamethasone 0.5 mg, ketorolac 10 mg, meloxicam 7.5 mg, ibuprofen 600 mg, or placebo by mouth 60 minutes before the administration of an IANB. Endodontic access will begin 15 minutes after completion of the IANB. The IANB success is defined as no or mild pain (Heft Parker 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, Vision Colleges
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05097768
- Sponsor's protocol ID
- 21-8/1
- Status last verified
- Feb 2022
- First submitted
- 17 Oct 2021
- Last updated
- 14 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nagendrababu V, Pulikkotil SJ, Veettil SK, Teerawattanapong N, Setzer FC. Effect of Nonsteroidal Anti-inflammatory Drug as an Oral Premedication on the Anesthetic Success of Inferior Alveolar Nerve Block in Treatment of Irreversible Pulpitis: A Systematic Review with Meta-analysis and Trial Sequential Analysis. J Endod. 2018 Jun;44(6):914-922.e2. doi: 10.1016/j.joen.2018.02.017. Epub 2018 Apr 27.
PubMed 29709297Pulikkotil 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 29480930Yadav 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 26410153Aggarwal 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 20171350
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Oral Premedication on the Success Rate of Inferior Alveolar Nerve Block in Patients With Symptomatic Irreversible Pulpitis: A Prospective, Double-blind, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05097768
- Acronym / sponsor ID
- 21-8/1
- Conditions
- Symptomatic Irreversible Pulpitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Alfarabi CollegesUniversity, hospital or other
- Study start
- 15 Aug 2021 (actual)
- Primary completion
- 15 Jan 2022 (actual)
- Study completion
- 27 Jan 2022 (actual)
- First posted
- 28 Oct 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.
Purpose: The aim of this prospective, double-blind, randomized controlled trial is to compare the effect of oral premedication of dexamethasone, ketorolac, meloxicam, ibuprofen or placebo on the success of inferior alveolar nerve blocks (IANB) of mandibular posterior teeth in patients experiencing symptomatic irreversible pulpitis. Methods: The trial will include five study groups, each consists of 50 patients who exhibits symptomatic irreversible pulpitis of a mandibular first or second molar. The patients will receive identically appearing capsules containing either dexamethasone 0.5 mg, ketorolac 10 mg, meloxicam 7.5 mg, ibuprofen 600 mg, or placebo by mouth 60 minutes before the administration of an IANB. Endodontic access will begin 15 minutes after completion of the IANB. The IANB success is defined as no or mild pain (Heft Parker visual analog scale recordings) on pulpal access or instrumentation.
Detailed description
This study is designed as a randomized, double-blind, placebo-controlled trial. This trial follows the most recent update of the Declaration of Helsinki criteria (October 2013). The Vision Colleges Research Ethics Committee approved the clinical trial protocol and informed consent. The Consolidated Standards of Reporting Trials guidelines will be used to report the present superiority study. Participants under the age of 18, those with a history of major medical issues, those who had used central nervous system depressants or any analgesic drug in the preceding 6 h, those who were pregnant, and those who were unable to give informed consent will be excluded from the study. All the patients will sign a consent form that had been approved.
The inclusion criteria will be active pain in the first or second mandibular molar, a prolonged response to cold testing, no periapical radiolucency on periapical radiographs, and a vital coronal pulp on access opening. The Modified Dental Anxiety Scale will be used to assess the patients' anxiety levels. The pain of the patients will be 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 Permuted block randomization will be used to ensure the homogeneity of the five groups. The patients will be randomly given dexamethasone 0.5 mg, ketorolac 10 mg, meloxicam 7.5 mg, ibuprofen 600 mg, or placebo by mouth 60 mins before administering IANB. To blind the experiment, each of the 50 patients in each group will be randomly allocated a code consists of 2 letters and one number. Only the random codes will identify the medications; thus, the patient and clinicians are uninformed of which medication will be given to them. At 60 mins after taking the medication or placebo, the operator will use a cotton tip applicator to put anaesthetic gel at the IANB injection site for 60 s.
The participants will then give regular IANB injections and 0.9 mL long buccal injections containing 2% lidocaine and 1:100,000 epinephrine. Each patient will be asked for lip numbness every 5 mins for 15 mins after the IANB. The block will be considered missed if substantial lip numbness was not reported by 15 mins, and the participant will be excluded from the trial. After the lip numbness is determined, the tooth will be isolated and a second cold test will be performed to verify the presence or absence of any painful reaction.
After that, the endodontic access will be conducted. During the endodontic process, patients will be asked to rate any pain they experienced. If the patient is in pain, the treatment will be stopped, and the patient will use the HP VAS to rate his/her discomfort. The success of the IANB is identified by the capability to access and clean and shape the root canal space without pain (VAS score of 0) or mild pain (VAS rating ≤54 mm). The rubber dam will be removed if the patient had moderate or severe pain (VAS rating ≥ 55 mm). Then, a buccal infiltration of a cartridge containing 4% articaine with 1:100,000 epinephrine will be given buccally to the tooth that required emergency treatment. After 5 mins, the rubber dam will be replaced, and endodontic access will be resumed. The capability to access and instrument the tooth without pain (VAS score of 0) or with mild pain (VAS rating ≤54 mm) is considered a success of the buccal infiltration. Intraosseous anesthesia will be given to the patients who still had moderate to severe pain. The intraosseous injection will be given. If that didn't work, an intrapulpal injection will be given, followed by endodontic debridement. The extent of access preparation and/or instrumentation will be recorded as within dentine, within pulp space, and instrumentation of canals.
The VAS satisfaction form will be used to record the post-treatment satisfaction of the patient. On the VAS (0-100 mm), the patient will be asked to draw a vertical line to represent their experience with the entire treatment. The VAS is 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
- Model description
- The trial will include five study groups, each consists of 50 patients who exhibits symptomatic irreversible pulpitis of a mandibular first or second molar. The patients will receive identically appearing capsules containing either dexamethasone 0.5 mg, ketorolac 10 mg, meloxicam 7.5 mg, ibuprofen 600 mg, or placebo by mouth 60 minutes before the administration of an IANB. Endodontic access will begin 15 minutes after completion of the IANB. The IANB success is defined as no or mild pain (Heft Parker visual analog scale recordings) on pulpal access or instrumentation.
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone | Active comparator | Drug: Dexamethasone 0.5mgBefore the inferior alveolar nerve block injection by 60 minutes, the patient will receive Dexamethasone 0.5 mg. |
| Ketorolac | Active comparator | Drug: Ketorolac 10 Mg Oral TabletBefore the inferior alveolar nerve block injection by 60 minutes, the patient will receive ketorolac 10 mg. |
| Meloxicam | Active comparator | Drug: Meloxicam 7.5 mgBefore the inferior alveolar nerve block injection by 60 minutes, the patient will receive meloxicam 7.5 mg. |
| Ibuprofen | Active comparator | Drug: Ibuprofen 600 mgBefore the inferior alveolar nerve block injection by 60 minutes, the patient will receive ibuprofen 600 mg. |
| Placebo | Placebo comparator | Drug: PlaceboBefore the inferior alveolar nerve block injection by 60 minutes, the patient will receive placebo. |
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 |
|---|---|---|
| Dexamethasone 0.5mgThe patients will be randomly given the medication by mouth 60 min before administering IANB. | Drug | Dexamethasone |
| Ketorolac 10 Mg Oral TabletThe patients will be randomly given the medication by mouth 60 min before administering IANB. | Drug | Ketorolac |
| Meloxicam 7.5 mgThe patients will be randomly given the medication by mouth 60 min before administering IANB. | Drug | Meloxicam |
| Ibuprofen 600 mgThe patients will be randomly given the medication by mouth 60 min before administering IANB. | Drug | Ibuprofen |
| PlaceboThe patients will be randomly given the medication by mouth 60 min before administering IANB. | Drug | Placebo |
Primary outcome
Pain Measurement as it will be 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 will be given inferior alveolar nerve block injection. Each patient will be asked for lip numbness every 5 minutes for 15 minutes after inferior alveolar nerve block injection. During the endodontic process, patients will be asked to rate any pain they experienced on a Heft-Parker visual analog scale. The number of millimeters along the scale will be reported. No pain corresponded to 0 mm. Mild pain is defined as greater than 0 mm and less than or equal to 54 mm. Mild pain is the descriptors of "faint", "weak", and "mild pain". Moderate pain is defined as greater than 54 mm and less than 114 mm and includes the descriptor "moderate". Severe pain is defined as equal to or greater than 114 mm up to and including 170 mm. Severe pain includes 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 14 Feb 2022.
- Background: PubMed 29709297Nagendrababu V, Pulikkotil SJ, Veettil SK, Teerawattanapong N, Setzer FC. Effect of Nonsteroidal Anti-inflammatory Drug as an Oral Premedication on the Anesthetic Success of Inferior Alveolar Nerve Block in Treatment of Irreversible Pulpitis: A Systematic Review with Meta-analysis and Trial Sequential Analysis. J Endod. 2018 Jun;44(6):914-922.e2. doi: 10.1016/j.joen.2018.02.017. Epub 2018 Apr 27.
- 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 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 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.
- Individual participant dataSharing planned: No
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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
Vision Colleges
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexamethasone 0.5mg, Ketorolac 10 Mg Oral Tablet and Meloxicam 7.5 mg 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 14 Feb 2022. 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 it will be 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 NCT05097768, which also lists 4 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 14 Feb 2022.