This Clinical Trial Aims to Compare the Effectiveness of Two Intra-pulpal Cryotherapy Techniques-Endo-ice and Ice Sticks-in Decreasing Intra-operative Pain and Enhancing the Success of Local Anesthesia During Pulpectomy of Mandibular Molars With Symptomatic Irreversible Pulpitis.

Summary

The goal of this clinical trail is to compare the analgesic effect of endo-ice and ice-sticks in reducing intra-operative pain during pulpectomy in molars with Symptomatic Irreversible Pulpitis. Principal Investigator will perform the procedure and outcome assessor will interview the participants as well as fill the pre-operative questionnaire. The patient will be instructed beforehand on how to score their pre-operative, intra-operative and post-operative intensity of pain according to Visual Analogue Scale.The Anxiety level of patient will also be recorded according to the Corah's Dental Anxiety Scale questionnaire and their level of anxiety before and after the intervention will be recorded by the outcome assessor.

The principal investigator will perform all endodontic procedures, with the outcome assessor blinded to the cryotherapy method. Prior to administering IANB, a topical anesthetic gel will be applied. A 27-gauge needle will deliver 1.8 ml of 2% lidocaine with 1:100,000 epinephrine at a rate of 1 ml/min. After a 5-minute wait, anesthesia effectiveness will be confirmed through electric pulp testing (EPT) on a neighboring tooth, with two consecutive negative responses confirming success. Once adequate anesthesia is confirmed, an access opening will be made under rubber dam isolation for the procedure.

1. CONTROL GROUP: After access opening and complete de-roofing of the pulp chamber, pulpectomy of the inflamed pulp will be performed under the given effective IANB with no additional intervention to control intra-operative pain.
2. ENDO-ICE GROUP: After access opening, pulp will be exposed and de-roofing will be performed. Endo-ice with the help of cotton pellet will be applied inside the pulp chamber for 2min (8 consecutive applications, 15sec each) and pulpectomy of the inflammed pulp will be performed immediately.
3. ICE-STICKS GROUP: Following the access opening and complete de-roofing of pulp chamber, four ice sticks will be placed inside the pulp chamber for 2 minutes (30 seconds each, using tweezer). Subsequently, pulpectomy of the inflamed pulp will be performed immediately.

Patients will be asked to rate their level of pain to the outcome assessor at four specific intervals during the trial, i.e., pre-operative (before local anesthesia), pre-operative (after local anesthesia), during pulpectomy and immediately after pulp extirpation and it will be recorded in a proforma by the blinded outcome assessor.

Pain and Anxiety Scores will be compared to asses either cryotherapy or which method of cryotherapy found to be effective in reducing intra-operative pain.

Conditions

• Root Canal Treatment
• Intra-operative Pain
• Symptomatic Irreversible Pulpitis
• Cryotherapy Effect

Interventions

OTHER

Endo-ice (Refrigerant Spray)

Endo-ice (1,1, 1,2-Tetrafluoroethane, Refrigerant spray) have been most frequently used in dentistry to assess pulp sensibility. In this study, Endo-ice will be used to perform intra-coronal cryotherapy and its effectiveness in reducing intra-operative pain will be evaluated.

OTHER

Ice-sticks

Ice-sticks have been mostly used in dentistry to assess pulp sensibility. In this study, Ice-sticks will be used to perform intra-coronal cryotherapy and it's effectiveness in reducing intra-operative pain will be evaluated.

Sponsors & Collaborators

• Dow University of Health Sciences

  lead OTHER

Principal Investigators

• Farah Naz, BDS, FCPS · Dow University of Health Sciences

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

40 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-04-15

Primary Completion

2026-07-30

Completion

2026-10-30

Countries

• Pakistan

Study Locations