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

NCT ID: NCT07036237

Last Updated: 2025-06-25

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-04
• Study Completion Date: 2025-11-17

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

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.

Conditions

Post-endodontic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Tramadol Group

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

Group Type: EXPERIMENTAL

Dexamethasone Group

Intervention Type: DRUG

drug used as a final irrigant

dexamethasone group

Dexamehasone as a final irrigant

Group Type: EXPERIMENTAL

Tramadol group

Intervention Type: DRUG

Drug used as final irrigant

Normal Saline group

normal saline as a final irrigant

Group Type: PLACEBO_COMPARATOR

Tramadol group

Intervention Type: DRUG

Drug used as final irrigant

Dexamethasone Group

Intervention Type: DRUG

drug used as a final irrigant

Interventions

Tramadol group

Drug used as final irrigant

Intervention Type: DRUG

Dexamethasone Group

drug used as a final irrigant

Intervention Type: DRUG

Other Intervention Names

Drug A; Drug B

Eligibility Criteria

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

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dow University of Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Hassan Mirza

MDS Trainee Of Operative Dentistry, Dow University Of Health Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Muhammad AM Amin, FCPS

Role: STUDY_CHAIR

Dow University of Health Sciences

Fazal FM Qazi, FCPS

Role: STUDY_DIRECTOR

Dow University of Health Sciences

Locations

DIOKHS,Dow University Of Health Sciences

Karachi, Sindh, Pakistan

Countries

Pakistan

Other Identifiers

HMIrza

Identifier Type: -

Identifier Source: org_study_id