Comparison Of The Effect Of Final Rinse Of Tramadol and Dexamethasone on Post-Endodontic Pain in Teeth With SIP

June 24, 2025 updated by: Hassan Mirza, Dow University of Health Sciences

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

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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

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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.

Study Type

Interventional

Enrollment (Estimated)

105

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, KARACHI WEST
        • DIOKHS,Dow University Of Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria

  • 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
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tramadol Group
Group A 30 participants will receive Tramadol as part of root canal treatment.
Drug: Dexamethasone Group
drug used as a final irrigant
Other Names:
  • Drug B
Experimental: dexamethasone group
Dexamehasone as a final irrigant
Drug: Tramadol group
Drug used as final irrigant
Other Names:
  • Drug A
Placebo Comparator: Normal Saline group
normal saline as a final irrigant
Drug: Dexamethasone Group
drug used as a final irrigant
Other Names:
  • Drug B
Drug: Tramadol group
Drug used as final irrigant
Other Names:
  • Drug A

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 to 48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dow University of Health Sciences

Investigators

  • Study Chair: Muhammad AM Amin, FCPS, Dow University of Health Sciences
  • Study Director: Fazal FM Qazi, FCPS, Dow University of Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 4, 2025

Primary Completion (Estimated)

November 17, 2025

Study Completion (Estimated)

November 17, 2025

Study Registration Dates

First Submitted

May 15, 2025

First Submitted That Met QC Criteria

June 24, 2025

First Posted (Estimated)

June 25, 2025

Study Record Updates

Last Update Posted (Estimated)

June 25, 2025

Last Update Submitted That Met QC Criteria

June 24, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HMIrza

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study will be published in a recongnized Journal to share with other researchers

IPD Sharing Time Frame

2to3years

IPD Sharing Access Criteria

Journal

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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