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.

NCT07264829 | Not Yet Recruiting

• 1 other identifier: IRB-3725/DUHS/Approval/2024/74
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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. 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.

Conditions

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

Keywords

Cryotherapy; Endodontic treatment; Intra-operative pain; Pulpectomy; Endo-ice; Ice-sticks; Symptomatic Irreversible Pulpitis

Outcome Measures

Primary Outcomes (1)

• Measuring Intra-operative pain using Visual Analogue Scale

  Patient will be interviewed at different intervals during the procedure and pain scores will recorded with the help of Visual Analogue Scale. This scale usually features a 10 cm line from score 0 to 10 with well-defined boundaries, where 0 indicates No Pain and 7-10 indicates Severe Pain.

  3 hours

Secondary Outcomes (1)

• Measuring Anxiety during procedure using Corah's Dental Anxiety Scale

  3 hours

Study Arms (3)

Control Group

NO INTERVENTION

The principal investigator will perform the endodontic procedure, 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. In 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 Inferior alveolar nerve block with no additional intervention to control intra-operative pain.

Endo-ice Group

EXPERIMENTAL

The principal investigator will perform the endodontic procedure, 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. In 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.

Other: Endo-ice (Refrigerant Spray)

Ice-sticks Group

EXPERIMENTAL

The principal investigator will perform the endodontic procedure, 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. In 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.

Other: Ice-sticks

Interventions

Ice-sticks OTHER

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.

Ice-sticks Group

Endo-ice (Refrigerant Spray) OTHER

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.

Endo-ice Group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Individuals (Male and Female) aged 18 to 40 years.
• Healthy individuals with no significant present and past medical findings.
• Mandibular molars.
• Symptomatic irreversible pulpitis (moderate to severe pain according to VAS 4-10).
• Periapical index (PAI) Score: 1-3 on periapical radiograph.
• DAS-R: 4-14( mild to moderate anxiety)

You may not qualify if:

• Immature teeth with open apices.
• Calcified pulp chamber and canals.
• Periodontally compromised teeth.
• Individuals who had taken steroids, analgesics, or antibiotics within the last 48 hours.

Sponsors & Collaborators

• Dow University of Health Sciences: lead

Study Sites (1)

Dow University of Health Sciences

Karachi, Sindh, 75600, Pakistan

Location

Study Officials

• Farah Naz, BDS, FCPS

  Dow University of Health Sciences

  STUDY CHAIR

Central Study Contacts

Tina Lohana

CONTACT

+923028328589; tinalohana.2823579@duhs.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: FCPS Resident

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: December 4, 2025
• Study Start: April 15, 2026
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)