Post-endodontic PainNCT07036237
Comparison Of The Effect Of Final Rinse Of Tramadol and Dexamethasone on Post-Endodontic Pain in Teeth With SIP
A study testing Tramadol group and Dexamethasone Group in people with Post-endodontic Pain, run by Dow University of Health Sciences at 1 site in Pakistan.
Trial summary
Briefly, 105 teeth with symptomatic irreversible pulpitis will be included in the study and randomly allocated to three groups (A, B and C). Pre-Operative pain score using VAS will be taken after which root canal treatment shall be initiated. Group A (35 teeth) will receive normal saline as a final irrigant. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Post-endodontic Pain
- What is being tested?
- Tramadol group and Dexamethasone Group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 1 sitePakistan
- Study dates
- 4 Mar 2025to 17 Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- ASA 1 and ASA 2 eligible patients
- Patients aged between 18 and 50 years
- Mandibular Single rooted teeth diagnosed with symptomatic irreversible pulpitis
- Preoperative pain measured with the help of visual analogue scale and
- Only one diseased tooth within the arch Exclusion Criteria
- Patients who have taken any analgesic at least 12 hours before the procedure
Show all 11Show fewer
- Teeth diagnosed with pulpal necrosis and periradicular periodontitis
- Teeth non restorable due to any reason,
- Root canal calcifications and resorptions.
- Women with breast feeding and pregnancy
- Patients allergic to any of the two drugs shall also be excluded from the study.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
DIOKHS,Dow University Of Health Sciences
Karachi, Sindh, KARACHI WEST
About this study
Official title: The Comparison Of The Effect Of Intracanal Rinse of Tramadol and Dexamethasone on Post-Endodontic Pain in Teeth With Symptomatic Irreversible Pulpitis: A Randomized Controlled Trial
Briefly, 105 teeth with symptomatic irreversible pulpitis will be included in the study and randomly allocated to three groups (A, B and C). Pre-Operative pain score using VAS will be taken after which root canal treatment shall be initiated. Group A (35 teeth) will receive normal saline as a final irrigant. 35 teeth each of Groups B and C will receive Dexamethasone and Tramadol Solutions, respectively as final irrigants. Post-operative pain scores will be recorded after 6, 12, 24 and 48 hours after the procedure. Statistical analysis will be performed using SPSS version 26.0. Mean comparison of pre-treatment and post-treatment VAS scores will be done by repeated measure two-way ANOVA. Post-hoc LSD test will be applied for pairwise comparison within and/or between groups.
The sample size of 105 subjects (35 including 5 as a drop out per group) is calculated using PASS version 15, based on two sample proportion with 95% confidence of interval and 80% power of test, no pain in dexamethasone (81.7%) and drug2
Read the detailed description
Diagnosis of symptomatic irreversible pulpitis will be made by Clinical and radiographic examination, electric pulp test and cold test. Patients included in the study will pick an envelope A, B or C for inclusion in the Group A, B or C. Researcher will himself be responsible for randomization and recruitment of participants into groups. In this Double blinded study neither clinician or patient will not know the drug of the envelope and the syringes will be masked by white paper labeled A, B and C by the dental assistant. They will be explained briefly about the procedure, safety, usefulness of the drug and informed consent will be taken (Appendix 1 \& 2 consent form). Pre-operative pain will be recorded using VAS. Treatment will be started by local anesthesia with Lidocaine 2% and Epinephrine 1:100,000 (Medicaine) and rubber dam (Medicom) isolation. Access opening will be done by EndoZ bur (Dentsply) and complete deroofing of the pulp chamber will be done.
Irrigation will be done by sodium hypochlorite 5% (i-dental) and root anal orifice will be located by DG-16 probe. #8 and #10 K-files (sybron endo) will be used for negotiating the canals. Working length will be taken by #20 K-file using apex locator(E-connect) and will be confirmed by periapical x-ray. Engine driven rotary motor (x smart, Dentsply) will be used to accomplish cleaning and shaping step of root canal treatment. Researcher will himself carry out single visit root canal treatment in mandibular teeth diagnosed symptomatic irreversible pulpitis with no peri-radicular periodontitis. Pro taper Gold (Dentsply) will be used for instrumentation with prescribed torque and rotations per minute. Root canal irrigation will be done after each step of filing with 5% sodium hypochlorite 2ml with final rinse of normal saline in all the groups. At this point, following drying the canals with paper points, Group A will receive 1ml of tramadol solution (Searle Pharma) 100mg/2ml for each canal Group B will
14
receive 1ml of dexamethasone solution (Searle Pharma) 4mg/1ml for each canal and group C will receive 1ml of normal saline solution for each canal as a final irrigant. Final irrigant will be activated with ultrasonic tip Model:E62 ENDODONTICS (Guilin Woodpecker Medical Instrument Co.Ltd) and canals will be dried with paperpoints. Filling of the canal will be done by gutta percha (Dentsply) and root canal sealer (Sealapex) by lateral compaction technique.
Permanent restoration will be placed on the same visit. Ibuprofen 400mg will be advised as a rescue oral pill and postoperative pain will be assessed by giving forms containing Visual Analogue Scale (Appendix 3) to fill at 6-, 12-,24 and 48-hours intervals. If the patient is illiterate, will be asked verbally to fill in the form. Patient will be called at the specified intervals for follow up and fill in the forms.
- Conditions
- Post-endodontic Pain
- Being tested
- Tramadol group, Dexamethasone Group
- Keywords
- Opiod analgesics, Root Canal Irrigant, Symptomatic Irreversible Pulpitis, SIP, Visual Analoque Scale, VAS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tramadol groupDrug
Also called Drug A
Drug used as final irrigant
Dexamethasone GroupDrug
Also called Drug B
drug used as a final irrigant
| Study group | Role | What they receive |
|---|---|---|
| Tramadol Group | Experimental | Group A 30 participants will receive Tramadol as part of root canal treatment. Receives: Drug: Dexamethasone Group |
| dexamethasone group | Experimental | Dexamehasone as a final irrigant Receives: Drug: Tramadol group |
| Normal Saline group | Placebo comparator | normal saline as a final irrigant Receives: Drug: Tramadol group; Drug: Dexamethasone Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-Operative Pain intensity
Measurement Tool : Visual Analogue Scale (VAS) Unit Of Measure : Pain intensity will be assessed on a 0-10 scale, where 0 represents no pain and 10 represents the worst pain imaginable.
Measured: 6 to 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start4 Mar 2025
- Primary completion17 Nov 2025 (estimated)
- Study completion17 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-endodontic PainStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hassan Mirza, Dow University of Health Sciences
- Investigators
- Muhammad AM Amin, FCPS, Study chair, Dow University of Health SciencesFazal FM Qazi, FCPS, Study director, Dow University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07036237
- Sponsor's protocol ID
- HMIrza
- Status last verified
- Jun 2025
- First submitted
- 15 May 2025
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study will be published in a recongnized Journal to share with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison Of The Effect Of Intracanal Rinse of Tramadol and Dexamethasone on Post-Endodontic Pain in Teeth With Symptomatic Irreversible Pulpitis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07036237
- Acronym / sponsor ID
- HMIrza
- Conditions
- Post-endodontic Pain
- Keywords
- Opiod analgesics, Root Canal Irrigant, Symptomatic Irreversible Pulpitis, SIP, Visual Analoque Scale, VAS
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- 4 Mar 2025 (actual)
- Primary completion
- 17 Nov 2025 (estimated)
- Study completion
- 17 Nov 2025 (estimated)
- First posted
- 25 Jun 2025 (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.
Briefly, 105 teeth with symptomatic irreversible pulpitis will be included in the study and randomly allocated to three groups (A, B and C). Pre-Operative pain score using VAS will be taken after which root canal treatment shall be initiated. Group A (35 teeth) will receive normal saline as a final irrigant. 35 teeth each of Groups B and C will receive Dexamethasone and Tramadol Solutions, respectively as final irrigants. Post-operative pain scores will be recorded after 6, 12, 24 and 48 hours after the procedure. Statistical analysis will be performed using SPSS version 26.0. Mean comparison of pre-treatment and post-treatment VAS scores will be done by repeated measure two-way ANOVA. Post-hoc LSD test will be applied for pairwise comparison within and/or between groups.
The sample size of 105 subjects (35 including 5 as a drop out per group) is calculated using PASS version 15, based on two sample proportion with 95% confidence of interval and 80% power of test, no pain in dexamethasone (81.7%) and drug2
Detailed description
Diagnosis of symptomatic irreversible pulpitis will be made by Clinical and radiographic examination, electric pulp test and cold test. Patients included in the study will pick an envelope A, B or C for inclusion in the Group A, B or C. Researcher will himself be responsible for randomization and recruitment of participants into groups. In this Double blinded study neither clinician or patient will not know the drug of the envelope and the syringes will be masked by white paper labeled A, B and C by the dental assistant. They will be explained briefly about the procedure, safety, usefulness of the drug and informed consent will be taken (Appendix 1 \& 2 consent form). Pre-operative pain will be recorded using VAS. Treatment will be started by local anesthesia with Lidocaine 2% and Epinephrine 1:100,000 (Medicaine) and rubber dam (Medicom) isolation. Access opening will be done by EndoZ bur (Dentsply) and complete deroofing of the pulp chamber will be done.
Irrigation will be done by sodium hypochlorite 5% (i-dental) and root anal orifice will be located by DG-16 probe. #8 and #10 K-files (sybron endo) will be used for negotiating the canals. Working length will be taken by #20 K-file using apex locator(E-connect) and will be confirmed by periapical x-ray. Engine driven rotary motor (x smart, Dentsply) will be used to accomplish cleaning and shaping step of root canal treatment. Researcher will himself carry out single visit root canal treatment in mandibular teeth diagnosed symptomatic irreversible pulpitis with no peri-radicular periodontitis. Pro taper Gold (Dentsply) will be used for instrumentation with prescribed torque and rotations per minute. Root canal irrigation will be done after each step of filing with 5% sodium hypochlorite 2ml with final rinse of normal saline in all the groups. At this point, following drying the canals with paper points, Group A will receive 1ml of tramadol solution (Searle Pharma) 100mg/2ml for each canal Group B will
14
receive 1ml of dexamethasone solution (Searle Pharma) 4mg/1ml for each canal and group C will receive 1ml of normal saline solution for each canal as a final irrigant. Final irrigant will be activated with ultrasonic tip Model:E62 ENDODONTICS (Guilin Woodpecker Medical Instrument Co.Ltd) and canals will be dried with paperpoints. Filling of the canal will be done by gutta percha (Dentsply) and root canal sealer (Sealapex) by lateral compaction technique.
Permanent restoration will be placed on the same visit. Ibuprofen 400mg will be advised as a rescue oral pill and postoperative pain will be assessed by giving forms containing Visual Analogue Scale (Appendix 3) to fill at 6-, 12-,24 and 48-hours intervals. If the patient is illiterate, will be asked verbally to fill in the form. Patient will be called at the specified intervals for follow up and fill in the forms.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tramadol Group | Experimental | Drug: Dexamethasone GroupGroup A 30 participants will receive Tramadol as part of root canal treatment. |
| dexamethasone group | Experimental | Drug: Tramadol groupDexamehasone as a final irrigant |
| Normal Saline group | Placebo comparator | Drug: Tramadol group, Drug: Dexamethasone Groupnormal saline as a final irrigant |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- ASA 1 and ASA 2 eligible patients
- Patients aged between 18 and 50 years
- Mandibular Single rooted teeth diagnosed with symptomatic irreversible pulpitis
- Preoperative pain measured with the help of visual analogue scale and
- Only one diseased tooth within the arch Exclusion Criteria
Key exclusion criteria (0 listed)
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 groupAlso: Drug ADrug used as final irrigant | Drug | Normal Saline group, dexamethasone group |
| Dexamethasone GroupAlso: Drug Bdrug used as a final irrigant | Drug | Normal Saline group, Tramadol Group |
Primary outcome
Post-Operative Pain intensity
Time frame: 6 to 48 hours
Measurement Tool : Visual Analogue Scale (VAS) Unit Of Measure : Pain intensity will be assessed on a 0-10 scale, where 0 represents no pain and 10 represents the worst pain imaginable.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
- Individual participant dataSharing planned: Yes. Study will be published in a recongnized Journal to share with other researchers
Related trials for Post-endodontic Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
Not yet recruiting
Effect of Intracanal Cryotherapy on Pain, Anxiety, and Salivary Irisin After Root Canal Treatment
Postoperative Pain After Endodontic Treatment, Dental Anxiety
Recruiting
Cryotherapy, PGE2, NGF Levels and Pain After Endodontic Retreatment
Asymptomatic Apical Periodontitis, Endodontic Retreatment
Recruiting
Effect of Different Apical Motion Algorithms on Postoperative Pain After Root Canal Treatment
Apical Periodontitis, Postoperative Pain After Endodontic Treatment
Not yet recruiting
Photobiomodulation After Nonsurgical Root Canal Treatment
Symptomatic Apical Periodontitis, Postoperative Pain
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.
Muhammad AM Amin, FCPS study chair
Dow University of Health Sciences
Fazal FM Qazi, FCPS study director
Dow University of Health Sciences
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 group and Dexamethasone Group in people with Post-endodontic Pain, run by Dow University of Health Sciences 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 11 inclusion and 0 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: enrolling by invitation, as of the sponsor's last update on 25 Jun 2025. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Post-Operative Pain intensity (time frame: 6 to 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jun 2025.