Root Canal TreatmentNCT07264829
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.
A study testing Endo-ice (Refrigerant Spray) and Ice-sticks in people with Root Canal Treatment and Intra-operative Pain, run by Dow University of Health Sciences at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Root Canal Treatment, Intra-operative Pain, Symptomatic Irreversible Pulpitis
- What is being tested?
- Endo-ice (Refrigerant Spray) and Ice-sticks
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Sep 2026to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparative Analysis of Intra-pulpal Cryotherapy Methods During Pulpectomy in Molars With Symptomatic Irreversible Pulpitis: A Randomized Control Trial
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.
Read more
- 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.
- 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.
- 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.
Read the detailed description
INTRODUCTION:
Acute pain associated with symptomatic irreversible pulpitis (SIP) can be induced by any stimuli or occur spontaneously and may persist for up to 30 seconds or beyond the removal of the stimulus, signaling the need for endodontic treatment. An essential prerequisite for successful endodontic therapy is effective pulpal anesthesia. The standard method for achieving regional anesthesia in mandibular molar involves an inferior alveolar nerve block (IANB) combined with buccal infiltration. However, an IANB does not always provide successful pulpal anesthesia, particularly in patients with symptomatic irreversible pulpitis (SIP).The occurrence of pain during endodontic treatment of teeth with SIP poses a significant challenge for both the clinician and the patient. In such circumstances, painless pulp extirpation becomes challenging. In endodontics, cryotherapy has been used following periradicular surgeries and as a final irrigant (cold saline) before obturation to reduce postoperative pain and inflammation.
METHODOLOGY:
This research will be conducted using a randomized controlled trial at Dow International Dental College. The target demographics includes 60 individuals with pain mandibular molars, experiencing moderate to severe pain (VAS 4-10), diagnosed with symptomatic irreversible pulpitis, planned for endodontic treatment. Pulpal sensibility will be assessed with cold test and electric pulp tester. Digital peri-apical x-rays will be used to evaluate the extent of caries and periapical status. Group allocation will be done by Computer generated random numbers. Individuals will be divided into 3 groups (20 each). 1. Control Group 2. Cryotherapy with endo-ice 3. Cryotherapy with ice-sticks. Cryotherapy methods (Endo-ice and Ice-sticks) will be used as an intervention to control per-operative pain in Intervention Groups and no additional measures will be taken to control pain in Control group, which is the standard method). After confirming the success of anesthesia, procedure will be started in all 3 groups.
The 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 VAS. Similarly, for anxiety assessment, the patients will be interviewed according to the DAS-R questionnaire and their level of anxiety before and after the intervention will be recorded by the outcome assesor.
- Conditions
- Root Canal Treatment, Intra-operative Pain, Symptomatic Irreversible Pulpitis, Cryotherapy Effect
- Being tested
- Endo-ice (Refrigerant Spray), Ice-sticks
- Keywords
- Cryotherapy, Endodontic treatment, Intra-operative pain, Pulpectomy, Endo-ice, Ice-sticks, Symptomatic Irreversible Pulpitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Ice-sticksOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Ice-sticks |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 hours
Secondary outcomes (1)
Measuring Anxiety during procedure using Corah's Dental Anxiety Scale
Patient will be interviewed by the outcome assessor before and after the procedure and anxiety will be measured using Corah's Dental Anxiety Scale. It consists of four scenarios pertaining to dental treatment, each with five response options that reflects varying levels of anxiety. The total of these responses varies from 4 to 20, with scores above 12 indicate nervous patients and above 15 indicates phobic levels of anxiety.
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start15 Sep 2026 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Root Canal TreatmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tina Lohana, Dow University of Health Sciences
- Investigators
- Farah Naz, BDS, FCPS, Study chair, Dow University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07264829
- Sponsor's protocol ID
- IRB-3725/DUHS/Approval/2024/74
- Status last verified
- Aug 2026
- First submitted
- 24 Nov 2025
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analysis of Intra-pulpal Cryotherapy Methods During Pulpectomy in Molars With Symptomatic Irreversible Pulpitis: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT07264829
- Acronym / sponsor ID
- IRB-3725/DUHS/Approval/2024/74
- Conditions
- Root Canal Treatment, Intra-operative Pain, Symptomatic Irreversible Pulpitis, Cryotherapy Effect
- Keywords
- Cryotherapy, Endodontic treatment, Intra-operative pain, Pulpectomy, Endo-ice, Ice-sticks, Symptomatic Irreversible Pulpitis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 4 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
- 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.
- 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.
Detailed description
INTRODUCTION:
Acute pain associated with symptomatic irreversible pulpitis (SIP) can be induced by any stimuli or occur spontaneously and may persist for up to 30 seconds or beyond the removal of the stimulus, signaling the need for endodontic treatment. An essential prerequisite for successful endodontic therapy is effective pulpal anesthesia. The standard method for achieving regional anesthesia in mandibular molar involves an inferior alveolar nerve block (IANB) combined with buccal infiltration. However, an IANB does not always provide successful pulpal anesthesia, particularly in patients with symptomatic irreversible pulpitis (SIP).The occurrence of pain during endodontic treatment of teeth with SIP poses a significant challenge for both the clinician and the patient. In such circumstances, painless pulp extirpation becomes challenging. In endodontics, cryotherapy has been used following periradicular surgeries and as a final irrigant (cold saline) before obturation to reduce postoperative pain and inflammation.
METHODOLOGY:
This research will be conducted using a randomized controlled trial at Dow International Dental College. The target demographics includes 60 individuals with pain mandibular molars, experiencing moderate to severe pain (VAS 4-10), diagnosed with symptomatic irreversible pulpitis, planned for endodontic treatment. Pulpal sensibility will be assessed with cold test and electric pulp tester. Digital peri-apical x-rays will be used to evaluate the extent of caries and periapical status. Group allocation will be done by Computer generated random numbers. Individuals will be divided into 3 groups (20 each). 1. Control Group 2. Cryotherapy with endo-ice 3. Cryotherapy with ice-sticks. Cryotherapy methods (Endo-ice and Ice-sticks) will be used as an intervention to control per-operative pain in Intervention Groups and no additional measures will be taken to control pain in Control group, which is the standard method). After confirming the success of anesthesia, procedure will be started in all 3 groups.
The 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 VAS. Similarly, for anxiety assessment, the patients will be interviewed according to the DAS-R questionnaire and their level of anxiety before and after the intervention will be recorded by the outcome assesor.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Endo-ice (Refrigerant Spray)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. |
| Ice-sticks Group | Experimental | Other: Ice-sticksThe 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Endo-ice Group |
| Ice-sticksIce-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. | Other | Ice-sticks Group |
Primary outcome
Measuring Intra-operative pain using Visual Analogue Scale
Time frame: 3 hours
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.
1 secondary outcome
Measuring Anxiety during procedure using Corah's Dental Anxiety Scale
Time frame: 3 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Root Canal Treatment
Recruiting
Effects of Different Activation Techniques on Antimicrobial Photodynamic Therapy in Apical Periodontitis
Apical Periodontitis, Endodontic Retreatment
Not yet recruiting
PRP-Assisted Regenerative Endodontics Versus Conventional Root Canal Treatment in Mature Necrotic Teeth
Pulp Necrosis, Apical Periodontitis
Not yet recruitingPhase 3
Submucosal Cryotherapy and Anti-inflammatory Drugs for Postoperative Pain Following Root Canal Treatment in Maxillary Molars
Pulpitis
Not yet recruiting
Clinical and Inflammatory Outcomes of Regenerative Endodontic Treatment Using Injectable Platelet-Rich Fibrin in Mature Necrotic Teeth With Chronic Apical Periodontitis.
Chronic Apical Periodontitis, Pulp Necrosis
Active, not recruiting
Early Healing of Apical Periodontitis After Root Canal Treatment With Bioceramic and Calcium Hydroxide Medicaments: Evaluation Using PAI and ImageJ
Apical Periodontitis, Root Canal Treatment
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Farah Naz, BDS, FCPS study chair
Dow University of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endo-ice (Refrigerant Spray) and Ice-sticks in people with Root Canal Treatment and Intra-operative Pain, run by Dow University of Health Sciences at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tina Lohana (+923028328589, tinalohana.2823579@duhs.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measuring Intra-operative pain using Visual Analogue Scale (time frame: 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.