Symptomatic Irreversible PulpitisPhase 4NCT05488925
Comparison of Preoperative Analgesics on the Efficacy of Inferior Alveolar Nerve Block.
A Phase 4 study testing Vitamin E, Diclofenac Sodium and Piroxicam in people with Symptomatic Irreversible Pulpitis, run by Farjad Zafar at 1 site in Pakistan.
Trial summary
The purpose of this study is to see how preoperative oral diclofenac sodium, piroxicam, and tramadol affects inferior alveolar nerve block efficacy during root canal treatment of mandibular molars with symptomatic irreversible pulpitis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Symptomatic Irreversible Pulpitis
- What is being tested?
- Vitamin E, Diclofenac Sodium and Piroxicam
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 sitePakistan
- Study dates
- 21 Jun 2021to 18 Feb 2022
- Phase
- Phase 4
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients between the ages of 18 - 65 years.
- Patients with no medical or systemic conditions.
- Patients with prolonged pain response on cold pulp testing of 1st and 2nd mandibular molars.
- Patient with 1st and 2nd mandibular molars having symptomatic irreversible pulpitis with no periapical pathology or tenderness on percussion.
- Preoperative moderate to severe pain on heft parker visual analogue scale.
- Patients who can understand the recording of the pain using heft parker visual analogue scale.
Who cannot join
- Patients who are pregnant and/or breastfeeding.
- Patients with reported allergy to diclofenac sodium, piroxicam, and tramadol.
- Patients with periodontal pathologies, necrotized pulp, ankylosed or resorbed roots, open apex and non-restorable tooth.
- Patients who have taken an analgesic in the past 24 hours.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Department of Operative Dentistry, Baqai Dental College, Baqai Medical University.
Karachi, Sindh, 75340
About this study
Official title: Comparison of Preoperative Analgesics on the Efficacy of Inferior Alveolar Nerve Block on Patients With Symptomatic Irreversible Pulpitis: a Double Blinded, Randomized Controlled Trial.
The purpose of this study is to see how preoperative oral diclofenac sodium, piroxicam, and tramadol affects inferior alveolar nerve block efficacy during root canal treatment of mandibular molars with symptomatic irreversible pulpitis.
The proposed hypothesis is that the tested drug groups will improve the efficacy of inferior alveolar nerve block in comparison to the control group.
Read the detailed description
Standard Operating Procedure:
- A non-probability consecutive sampling was done in a dental out patient department and 120 patients were included and randomly divided in the 4 groups (n=30) using simple randomization as per the inclusion criteria.
- A verbal informed consent was taken from each participant before including them in a group.
- The study was designed to be a double blinded study, where the researchers and the patients both were unaware of the groups of drugs that were used; this anonymity was achieved by marking the groups A, B, C and D on boxes for drugs containing a placebo, diclofenac sodium, piroxicam, and tramadol respectively.
- The Heft Parker Visual Analogue Scale was used to assess the patients' pain levels prior to the drug ingestion, and the study was continued on the patients that reported moderate to severe pain on the Visual Analogue Scale. On this scale, the pain intensities were categorized as: no pain (0), mild pain (1-54 mm), moderate pain (55- 114 mm) and severe pain (> 114 mm).
- The patients were then given their respective group of drug/placebo. The patients were instructed to wait for 1 hour before they were administered Inferior Alveolar Nerve Block with 1.8 ml of 2% lidocaine with 1:100000 epinephrine using a non-aspirating syringe through a long needle of 27-Gauge.
- Standard root canal treatment was initiated after lip numbness was achieved, and pain levels were reassessed by Heft Parker Visual Analogue Scale during the root canal procedure. However, the patients who did not achieve the numbness of the lips were excluded from the study.
- Patients who reported discomfort and pain during the endodontic procedure were intervened appropriately; conversely, if the patient did not report any intraoperative pain, endodontic procedure was resumed.
- Till the end of the data collection process, the collected data forms were stored in a 4 different files labeled A ,B ,C and D respective to the drug groups. On completion of the collection process the data was added and stored as a data file into IBM SPSS Statistics version 25 and further analyzed.
Sample Size Estimation:
The study size was calculated with reference to previous reports, revealing that at least 30 individuals should be included as per the analysis of power of the study. The value of power used was 0.96, the effect size was taken as 0.4, and α was set as 0.05.
Statistical Analysis Plan:
Test of normality will be checked using one sample Shapiro Wilk. One-way ANOVA with Tukey's post-hoc will be employed if parametric test criteria is met; however if the parametric criteria is not fulfilled, the experimental groups will be compared using Kruskal-Wallis test with post-hoc analysis. The Chi-square test will be used to compare gender and drug groups against the Inferior Alveolar Nerve Block efficacy. These tests will be conducted on SPSS Statistics version 25.
- Conditions
- Symptomatic Irreversible Pulpitis
- Being tested
- Vitamin E, Diclofenac Sodium, Piroxicam, Tramadol
- Keywords
- inferior alveolar nerve block, irreversible pulpitis, diclofenac sodium, piroxicam, tramadol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin EDrug
Evion, 400 mg
Diclofenac SodiumDrug
Voltral SR100, 100 mg
PiroxicamDrug
Feldene, 20 mg
TramadolDrug
Tramal, 50 mg
| Study group | Role | What they receive |
|---|---|---|
| Vitamin E | Placebo comparator | Not described Receives: Drug: Vitamin E |
| Diclofenac sodium | Experimental | Not described Receives: Drug: Diclofenac Sodium |
| Piroxicam | Experimental | Not described Receives: Drug: Piroxicam |
| Tramadol | Experimental | Not described Receives: Drug: Tramadol |
What is being measured
The primary outcome is the main question the study is designed to answer.
To check the efficacy of preoperative analgesics on inferior alveolar nerve block using Heft-Parker Visual Analogue Scale.
Study's outcome is to evaluate the efficacy of different preoperative oral analgesics on inferior alveolar nerve block during root canal procedure of mandibular teeth using Heft-Parker Visual Analogue Scale on symptomatic irreversible pulpitis patients
Heft-Parker Visual Analogue Scale is a visual assessment tool to record patients pain intensity. This scale is categorized as: no pain (0mm), moderate pain (55-114mm), and severe pain (>114mm)
- Patients will register their Heft-Parker Visual Analogue Scale recording to the investigator before drug ingestion
- Patients will re-register their Heft-Parker Visual Analogue Scale 1 hour after the drug ingestion, during root canal procedure after inferior alveolar nerve block
- The difference in the preoperative and intraoperative Heft-Parker Visual Analogue Scale score will determine the efficacy of different analgesic interventional groups
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2022
- Study start21 Jun 2021
- Primary completion18 Feb 2022
- Study completion18 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The visual analogue scale was used to assess the patients' pain levels prior to the drug ingestion. The patients were then given their respective group of drug where the control group received vitamin E and three experimental groups received one tablet/capsule of diclofenac sodium (Voltral SR100, 100 mg), piroxicam (Feldene, 20 mg), and tramadol (Tramal, 50 mg). The patients were instructed to wait for 1 hour before they were administered an inferior alveolar nerve block. Standard root canal treatment was initiated after lip numbness was achieved, and pain levels were reassessed by visual analogue scale.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Farjad Zafar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Farjad Zafar, Baqai Medical University
- Investigators
- Farjad Zafar, BDS, MSc, Study director, Assistant Professor and Head of Department of Dental Implantology.Maryam Riaz, BDS, Principal investigator, Lecturer in Department of Oral Biology.Zara Khalid, BDS, Principal investigator, House officer.Tipu Sultan, BDS, MDS, Principal investigator, Assistant Professor in Department of Periodontology.Aisha Wali, BDS, MPH, Study director, Assistant Professor and Head of Department of Research and Development.Talha M Siddiqui, BDS, MCPS, Study chair, Professor and Chairman of Operative Dentistry and Endodontics.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05488925
- Sponsor's protocol ID
- BDC/ERB/2021/016
- Status last verified
- Aug 2022
- First submitted
- 2 Aug 2022
- Last updated
- 5 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD will be shared with the researchers who have received an ethical approval from their institution/organization through an email.
Publications
Prasanna N, Subbarao CV, Gutmann JL. The efficacy of pre-operative oral medication of lornoxicam and diclofenac potassium on the success of inferior alveolar nerve block in patients with irreversible pulpitis: a double-blind, randomised controlled clinical trial. Int Endod J. 2011 Apr;44(4):330-6. doi: 10.1111/j.1365-2591.2010.01833.x.
PubMed 21692235
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Preoperative Analgesics on the Efficacy of Inferior Alveolar Nerve Block on Patients With Symptomatic Irreversible Pulpitis: a Double Blinded, Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT05488925
- Acronym / sponsor ID
- BDC/ERB/2021/016
- Conditions
- Symptomatic Irreversible Pulpitis
- Keywords
- inferior alveolar nerve block, irreversible pulpitis, diclofenac sodium, piroxicam, tramadol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Farjad ZafarUniversity, hospital or other
- Study start
- 21 Jun 2021 (actual)
- Primary completion
- 18 Feb 2022 (actual)
- Study completion
- 18 Feb 2022 (actual)
- First posted
- 5 Aug 2022 (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.
The purpose of this study is to see how preoperative oral diclofenac sodium, piroxicam, and tramadol affects inferior alveolar nerve block efficacy during root canal treatment of mandibular molars with symptomatic irreversible pulpitis.
The proposed hypothesis is that the tested drug groups will improve the efficacy of inferior alveolar nerve block in comparison to the control group.
Detailed description
Standard Operating Procedure:
- A non-probability consecutive sampling was done in a dental out patient department and 120 patients were included and randomly divided in the 4 groups (n=30) using simple randomization as per the inclusion criteria.
- A verbal informed consent was taken from each participant before including them in a group.
- The study was designed to be a double blinded study, where the researchers and the patients both were unaware of the groups of drugs that were used; this anonymity was achieved by marking the groups A, B, C and D on boxes for drugs containing a placebo, diclofenac sodium, piroxicam, and tramadol respectively.
- The Heft Parker Visual Analogue Scale was used to assess the patients' pain levels prior to the drug ingestion, and the study was continued on the patients that reported moderate to severe pain on the Visual Analogue Scale. On this scale, the pain intensities were categorized as: no pain (0), mild pain (1-54 mm), moderate pain (55- 114 mm) and severe pain (> 114 mm).
- The patients were then given their respective group of drug/placebo. The patients were instructed to wait for 1 hour before they were administered Inferior Alveolar Nerve Block with 1.8 ml of 2% lidocaine with 1:100000 epinephrine using a non-aspirating syringe through a long needle of 27-Gauge.
- Standard root canal treatment was initiated after lip numbness was achieved, and pain levels were reassessed by Heft Parker Visual Analogue Scale during the root canal procedure. However, the patients who did not achieve the numbness of the lips were excluded from the study.
- Patients who reported discomfort and pain during the endodontic procedure were intervened appropriately; conversely, if the patient did not report any intraoperative pain, endodontic procedure was resumed.
- Till the end of the data collection process, the collected data forms were stored in a 4 different files labeled A ,B ,C and D respective to the drug groups. On completion of the collection process the data was added and stored as a data file into IBM SPSS Statistics version 25 and further analyzed.
Sample Size Estimation:
The study size was calculated with reference to previous reports, revealing that at least 30 individuals should be included as per the analysis of power of the study. The value of power used was 0.96, the effect size was taken as 0.4, and α was set as 0.05.
Statistical Analysis Plan:
Test of normality will be checked using one sample Shapiro Wilk. One-way ANOVA with Tukey's post-hoc will be employed if parametric test criteria is met; however if the parametric criteria is not fulfilled, the experimental groups will be compared using Kruskal-Wallis test with post-hoc analysis. The Chi-square test will be used to compare gender and drug groups against the Inferior Alveolar Nerve Block efficacy. These tests will be conducted on SPSS Statistics version 25.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
- Model description
- The visual analogue scale was used to assess the patients' pain levels prior to the drug ingestion. The patients were then given their respective group of drug where the control group received vitamin E and three experimental groups received one tablet/capsule of diclofenac sodium (Voltral SR100, 100 mg), piroxicam (Feldene, 20 mg), and tramadol (Tramal, 50 mg). The patients were instructed to wait for 1 hour before they were administered an inferior alveolar nerve block. Standard root canal treatment was initiated after lip numbness was achieved, and pain levels were reassessed by visual analogue scale.
| Arm | Type | Receives |
|---|---|---|
| Vitamin E | Placebo comparator | Drug: Vitamin E |
| Diclofenac sodium | Experimental | Drug: Diclofenac Sodium |
| Piroxicam | Experimental | Drug: Piroxicam |
| Tramadol | Experimental | Drug: Tramadol |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients between the ages of 18 - 65 years.
- Patients with no medical or systemic conditions.
- Patients with prolonged pain response on cold pulp testing of 1st and 2nd mandibular molars.
- Patient with 1st and 2nd mandibular molars having symptomatic irreversible pulpitis with no periapical pathology or tenderness on percussion.
- Preoperative moderate to severe pain on heft parker visual analogue scale.
Key exclusion criteria (4 listed)
- Patients who are pregnant and/or breastfeeding.
- Patients with reported allergy to diclofenac sodium, piroxicam, and tramadol.
- Patients with periodontal pathologies, necrotized pulp, ankylosed or resorbed roots, open apex and non-restorable tooth.
- Patients who have taken an analgesic in the past 24 hours.
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 |
|---|---|---|
| Vitamin EEvion, 400 mg | Drug | Vitamin E |
| Diclofenac SodiumVoltral SR100, 100 mg | Drug | Diclofenac sodium |
| PiroxicamFeldene, 20 mg | Drug | Piroxicam |
| TramadolTramal, 50 mg | Drug | Tramadol |
Primary outcome
To check the efficacy of preoperative analgesics on inferior alveolar nerve block using Heft-Parker Visual Analogue Scale.
Time frame: 1 hour
Study's outcome is to evaluate the efficacy of different preoperative oral analgesics on inferior alveolar nerve block during root canal procedure of mandibular teeth using Heft-Parker Visual Analogue Scale on symptomatic irreversible pulpitis patients Heft-Parker Visual Analogue Scale is a visual assessment tool to record patients pain intensity. This scale is categorized as: no pain (0mm), moderate pain (55-114mm), and severe pain (>114mm) * Patients will register their Heft-Parker Visual Analogue Scale recording to the investigator before drug ingestion * Patients will re-register their Heft-Parker Visual Analogue Scale 1 hour after the drug ingestion, during root canal procedure after inferior alveolar nerve block * The difference in the preoperative and intraoperative Heft-Parker Visual Analogue Scale score will determine the efficacy of different analgesic interventional groups
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 5 Aug 2022.
- Results publication: PubMed 21692235Prasanna N, Subbarao CV, Gutmann JL. The efficacy of pre-operative oral medication of lornoxicam and diclofenac potassium on the success of inferior alveolar nerve block in patients with irreversible pulpitis: a double-blind, randomised controlled clinical trial. Int Endod J. 2011 Apr;44(4):330-6. doi: 10.1111/j.1365-2591.2010.01833.x.
- Individual participant dataSharing planned: Yes. All collected IPD will be shared with the researchers who have received an ethical approval from their institution/organization through an email.
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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.
Farjad Zafar, BDS, MSc study director
Assistant Professor and Head of Department of Dental Implantology.
Maryam Riaz, BDS principal investigator
Lecturer in Department of Oral Biology.
Zara Khalid, BDS principal investigator
House officer.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vitamin E, Diclofenac Sodium and Piroxicam in people with Symptomatic Irreversible Pulpitis, run by Farjad Zafar at 1 site in Pakistan.
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 6 inclusion and 4 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 5 Aug 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 Pakistan. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
To check the efficacy of preoperative analgesics on inferior alveolar nerve block using Heft-Parker Visual Analogue Scale. (time frame: 1 hour). 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 NCT05488925, which also lists 1 linked publication.
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 5 Aug 2022.