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

NCT07036237 | Enrolling By Invitation

• 1 other identifier: HMIrza
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Post-endodontic Pain

Keywords

Opiod analgesics; Root Canal Irrigant; Symptomatic Irreversible Pulpitis; SIP; Visual Analoque Scale; VAS

Outcome Measures

Primary Outcomes (1)

• 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.

  6 to 48 hours

Study Arms (3)

Tramadol Group

EXPERIMENTAL

Group A 30 participants will receive Tramadol as part of root canal treatment.

Drug: Dexamethasone Group

dexamethasone group

EXPERIMENTAL

Dexamehasone as a final irrigant

Drug: Tramadol group

Normal Saline group

PLACEBO COMPARATOR

normal saline as a final irrigant

Drug: Tramadol group; Drug: Dexamethasone Group

Interventions

Tramadol group DRUG

Drug used as final irrigant

Also known as: Drug A

Normal Saline group; dexamethasone group

Dexamethasone Group DRUG

drug used as a final irrigant

Also known as: Drug B

Normal Saline group; Tramadol Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dow University of Health Sciences: lead

Study Sites (1)

DIOKHS,Dow University Of Health Sciences

Karachi, Sindh, KARACHI WEST, Pakistan

Location

Study Officials

• Muhammad AM Amin, FCPS

  Dow University of Health Sciences

  STUDY CHAIR

• Fazal FM Qazi, FCPS

  Dow University of Health Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MDS Trainee Of Operative Dentistry, Dow University Of Health Sciences

Study Record Dates

• First Submitted: May 15, 2025
• First Posted: June 25, 2025
• Study Start: March 4, 2025
• Primary Completion: November 17, 2025
• Study Completion: November 17, 2025
• Last Updated: June 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 2to3years
• Access Criteria: Journal

Locations

PA (1)