An interventional study of Tramadol group and Dexamethasone Group in Post-endodontic Pain, sponsored by Dow University of Health Sciences. Enrolling by invitation at 1 site in Pakistan. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-25.
Sponsored by Dow University of Health Sciences · Not applicable, Interventional, and Prevention
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
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
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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.
Dow University of Health Sciences is the lead sponsor of 170 studies on the registry; 30 are open to participants now.
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Inclusion Criteria
Group A 30 participants will receive Tramadol as part of root canal treatment.
Drug: Dexamethasone Group
Dexamehasone as a final irrigant
Drug: Tramadol group
normal saline as a final irrigant
Drug: Tramadol group · Drug: Dexamethasone Group
Drug used as final irrigant
Also known as: Drug A
drug used as a final irrigant
Also known as: Drug B
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.
Time frame: 6 to 48 hours
Plan to share: Yes — Study will be published in a recongnized Journal to share with other researchers
Supporting information: Study protocol
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Dow University of Health Sciences