Post-operative PainNaOCl/VPT/MTANCT07764666
Compare the Impact of Sodium Hypochlorite and Saline Irrigation Protocols With and Without Cryotherapy on Post-operative Pain Following Pulpotomy in Permanent Mandibular Molar Teeth.
A study testing VPT /pulpotomy, VPT/complete pulpotomy and vital pulp therapy /complete pulpotomy in people with Post-operative Pain and Vital Pulp Therapy, run by Abdelrahman Refaat Khalaf Ahmed at 1 site in Egypt.
Trial summary
The aim of the present study will compare the impact of sodium hypochlorite and saline irrigation protocols with and without cryotherapy on post-operative pain following pulpotomy in permanent mandibular molar teeth.Will the use of sodium hypochlorite and saline irrigation protocols with and without cryotherapy have… Read more about this study
- Who is it for?
- Ages 15 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Post-operative Pain, Vital Pulp Therapy
- What is being tested?
- VPT /pulpotomy, VPT/complete pulpotomy and vital pulp therapy /complete pulpotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2026to 1 Feb 2027
- 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 15 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Eligibility criteria:
A- Inclusion criteria:
- Tooth show positive response to sensitivity test.
- Haemostasias can be achieved after total pulpotomy.
- The tooth is restorable and free from advanced periodontal disease, cracks and splits.
- Patients suffering from Symptomatic irreversible pulpitis in mature mandibular molars teeth only will be involved.
- Patients of either gender aged from 15-40.
- Patients should be free from any systemic disease that may affect normal healing and predictable outcome.
- Patients who will agree to the consent and will commit to follow-up period.
- Patients with mature root.
- Patients with no internal or external resorption and no periapical lesions.
- Soft tissues around the tooth are normal with no swelling or sinus tract.
B- Exclusion criteria:
- Patients with immature roots.
- Haemostasias after 10 minutes can not be controlled after total pulpotomy
- Patients with any systemic disease that may affect normal healing.
- Patients with periapical lesions or infections.
- Pregnant females.
- Patients who could/would not participate in a 6 months follow-up.
- Patients with fistula or swelling
- Patients with necrotic pulp.
- Patients with old age.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Faculty of Oral and Dental Medicine future university, Cairo,
Cairo, Cairo Governorate, 11835
About this study
Official title: Compare the Impact of Sodium Hypochlorite and Saline Irrigation Protocols With and Without Cryotherapy on Post-operative Pain Following Pulpotomy in Permanent Mandibular Molar Teeth. "Randomized Controlled Trial"
The aim of the present study will compare the impact of sodium hypochlorite and saline irrigation protocols with and without cryotherapy on post-operative pain following pulpotomy in permanent mandibular molar teeth.Will the use of sodium hypochlorite and saline irrigation protocols with and without cryotherapy have an effect on post-operative pain and overall success following pulpotomy in permanent mandibular molar compared to normal saline irrigation ?
Read the detailed description
Cryotherapy is another modified technique for pulpotomy,, lowering the temperature of the target tissue will help in eradication or diminishing of the pain experienced by patients in many medical conditions before it was adopted to dental pain cases. Although these theoretical benefits are promising, the clinical evidence directly comparing cryotherapy-assisted irrigation with standard NaOCl or saline protocols in pulpotomy remains limited. Therefore, the present study is to compare the impact of sodium hypochlorite and saline irrigation protocols with and without cryotherapy on post-operative pain following pulpotomy in permanent mandibular molar teeth.
- Conditions
- Post-operative Pain, Vital Pulp Therapy
- Being tested
- VPT /pulpotomy, VPT/complete pulpotomy, vital pulp therapy /complete pulpotomy
- Keywords
- cryotherapy /pulpotomy /post operative pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VPT /pulpotomyProcedure or surgery
Endodontic procedure:
The procedures will be performed under local anesthesia with Lidocaine 2% and adrenaline 1/100,000. Teeth will be isolated with rubber dam. Caries will be completely removed with a sterile diamond stone (size 2) under an operating surgical microscope.
The access cavity will be prepared up to the level of pulp chamber floor using sterile round diamond bur size 2 in high-speed hand piece with coolant.Once the pulp has been reached, a sharp sterile spoon excavator should be used to remove the pulp tissue to the level of the radicular pulp.
Hemostasis will be achieved by irrigating the prepared cavity with volume 3ml of irrigant for up to 6 minutes over the pulp stump. If hemostasis cannot be achieved after 6 mins, the tooth should undergo pulpectomy and Root Canal treatment as per the clinician's normal practice.
VPT/complete pulpotomyProcedure or surgery
Endodontic procedure:
The procedures will be performed under local anesthesia with Lidocaine 2% and adrenaline 1/100,000. Teeth will be isolated with rubber dam. Caries will be completely removed with a sterile diamond stone (size 2) under an operating surgical microscope.
The access cavity will be prepared up to the level of pulp chamber floor using sterile round diamond bur size 2 in high-speed hand piece with coolant.Once the pulp has been reached, a sharp sterile spoon excavator should be used to remove the pulp tissue to the level of the radicular pulp.
Hemostasis will be achieved by irrigating the prepared cavity with volume 3ml of irrigant for up to 6 minutes over the pulp stump. If hemostasis cannot be achieved after 6 mins, the tooth should undergo pulpectomy and Root Canal treatment as per the clinician's normal practice.
vital pulp therapy /complete pulpotomyProcedure or surgery
Endodontic procedure:
The procedures will be performed under local anesthesia with Lidocaine 2% and adrenaline 1/100,000. Teeth will be isolated with rubber dam. Caries will be completely removed with a sterile diamond stone (size 2) under an operating surgical microscope.
The access cavity will be prepared up to the level of pulp chamber floor using sterile round diamond bur size 2 in high-speed hand piece with coolant.Once the pulp has been reached, a sharp sterile spoon excavator should be used to remove the pulp tissue to the level of the radicular pulp.
Hemostasis will be achieved by irrigating the prepared cavity with volume 3ml of irrigant for up to 6 minutes over the pulp stump. If hemostasis cannot be achieved after 6 mins, the tooth should undergo pulpectomy and Root Canal treatment as per the clinician's normal practice.
| Study group | Role | What they receive |
|---|---|---|
| 2.5% NAOCL | Experimental | intervention group and the pulpotomy irrigation agent will be NAOCL2.5%. Receives: Procedure: VPT /pulpotomy |
| cryotherapy enhanced with 2.5% NAOCL | Experimental | the intervention group and the pulpotomy irrigation agent will be cryotherapy with NAOCL2.5%. Receives: Procedure: VPT/complete pulpotomy |
| cryotherapy enhanced with saline | Experimental | the intervention group and the pulpotomy irrigation agent will be cryotherapy with saline Receives: Procedure: vital pulp therapy /complete pulpotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
post operative pain
Postoperative pain reported by the patient after pulpotomy in groups is to be recorded by NRS (Numerical Rate Scale). Scale from 0-10 recorded every 24hours until the seventh day. The NRS for pain is a straight line with one end (point 0) meaning no pain and the other end (point 10) meaning the worst pain imaginable.
Measured: Pain will be recorded preoperative and after 6 hours, 12 hours , 24 hours , 72 hours and 1 week using numerical rate scale (NRS)
Secondary outcomes (1)
Clinical and Digital radiograph overall success
Assess the overall success (absence of spontaneous pain or periapical radiolucency and pulp is vital) after vital pulp therapy in symptomatic irreversible pulpitis of mandibular permanent molar teeth
Measured: 3 month ,6 month and 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2026
- Study start1 Jan 2026
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-operative PainStudies 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
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 3 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abdelrahman Refaat Khalaf Ahmed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Abdelrahman Refaat Khalaf Ahmed, Future University in Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07764666
- Sponsor's protocol ID
- FUE.REC(16)/1-2026
- Acronym
- NaOCl/VPT/MTA
- Status last verified
- Dec 2025
- First submitted
- 9 Aug 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: only IPD used in the results publication
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compare the Impact of Sodium Hypochlorite and Saline Irrigation Protocols With and Without Cryotherapy on Post-operative Pain Following Pulpotomy in Permanent Mandibular Molar Teeth. "Randomized Controlled Trial"
- ClinicalTrials.gov ID
- NCT07764666
- Acronym / sponsor ID
- NaOCl/VPT/MTA / FUE.REC(16)/1-2026
- Conditions
- Post-operative Pain, Vital Pulp Therapy
- Keywords
- cryotherapy /pulpotomy /post operative pain
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 3 participants (estimated)
- Lead sponsor
- Abdelrahman Refaat Khalaf AhmedUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 14 Aug 2026 (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 aim of the present study will compare the impact of sodium hypochlorite and saline irrigation protocols with and without cryotherapy on post-operative pain following pulpotomy in permanent mandibular molar teeth.Will the use of sodium hypochlorite and saline irrigation protocols with and without cryotherapy have an effect on post-operative pain and overall success following pulpotomy in permanent mandibular molar compared to normal saline irrigation ?
Detailed description
Cryotherapy is another modified technique for pulpotomy,, lowering the temperature of the target tissue will help in eradication or diminishing of the pain experienced by patients in many medical conditions before it was adopted to dental pain cases. Although these theoretical benefits are promising, the clinical evidence directly comparing cryotherapy-assisted irrigation with standard NaOCl or saline protocols in pulpotomy remains limited. Therefore, the present study is to compare the impact of sodium hypochlorite and saline irrigation protocols with and without cryotherapy on post-operative pain following pulpotomy in permanent mandibular molar teeth.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 2.5% NAOCL | Experimental | Procedure: VPT /pulpotomyintervention group and the pulpotomy irrigation agent will be NAOCL2.5%. |
| cryotherapy enhanced with 2.5% NAOCL | Experimental | Procedure: VPT/complete pulpotomythe intervention group and the pulpotomy irrigation agent will be cryotherapy with NAOCL2.5%. |
| cryotherapy enhanced with saline | Experimental | Procedure: vital pulp therapy /complete pulpotomythe intervention group and the pulpotomy irrigation agent will be cryotherapy with saline |
Who may qualify
- Ages
- 15 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
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 |
|---|---|---|
| VPT /pulpotomyEndodontic procedure: The procedures will be performed under local anesthesia with Lidocaine 2% and adrenaline 1/100,000. Teeth will be isolated with rubber dam. Caries will be completely removed with a sterile diamond stone (size 2) under an operating surgical microscope. The access cavity will be prepared up to the level of pulp chamber floor using sterile round diamond bur size 2 in high-speed hand piece with coolant.Once the pulp has been reached, a sharp sterile spoon excavator should be used to remove the pulp tissue to the level of the radicular pulp. Hemostasis will be achieved by irrigating the prepared cavity with volume 3ml of irrigant for up to 6 minutes over the pulp stump. If hemostasis cannot be achieved after 6 mins, the tooth should undergo pulpectomy and Root Canal treatment as per the clinician's normal practice. | Procedure or surgery | 2.5% NAOCL |
| VPT/complete pulpotomyEndodontic procedure: The procedures will be performed under local anesthesia with Lidocaine 2% and adrenaline 1/100,000. Teeth will be isolated with rubber dam. Caries will be completely removed with a sterile diamond stone (size 2) under an operating surgical microscope. The access cavity will be prepared up to the level of pulp chamber floor using sterile round diamond bur size 2 in high-speed hand piece with coolant.Once the pulp has been reached, a sharp sterile spoon excavator should be used to remove the pulp tissue to the level of the radicular pulp. Hemostasis will be achieved by irrigating the prepared cavity with volume 3ml of irrigant for up to 6 minutes over the pulp stump. If hemostasis cannot be achieved after 6 mins, the tooth should undergo pulpectomy and Root Canal treatment as per the clinician's normal practice. | Procedure or surgery | cryotherapy enhanced with 2.5% NAOCL |
| vital pulp therapy /complete pulpotomyEndodontic procedure: The procedures will be performed under local anesthesia with Lidocaine 2% and adrenaline 1/100,000. Teeth will be isolated with rubber dam. Caries will be completely removed with a sterile diamond stone (size 2) under an operating surgical microscope. The access cavity will be prepared up to the level of pulp chamber floor using sterile round diamond bur size 2 in high-speed hand piece with coolant.Once the pulp has been reached, a sharp sterile spoon excavator should be used to remove the pulp tissue to the level of the radicular pulp. Hemostasis will be achieved by irrigating the prepared cavity with volume 3ml of irrigant for up to 6 minutes over the pulp stump. If hemostasis cannot be achieved after 6 mins, the tooth should undergo pulpectomy and Root Canal treatment as per the clinician's normal practice. | Procedure or surgery | cryotherapy enhanced with saline |
Primary outcome
post operative pain
Time frame: Pain will be recorded preoperative and after 6 hours, 12 hours , 24 hours , 72 hours and 1 week using numerical rate scale (NRS)
Postoperative pain reported by the patient after pulpotomy in groups is to be recorded by NRS (Numerical Rate Scale). Scale from 0-10 recorded every 24hours until the seventh day. The NRS for pain is a straight line with one end (point 0) meaning no pain and the other end (point 10) meaning the worst pain imaginable.
1 secondary outcome
Clinical and Digital radiograph overall success
Time frame: 3 month ,6 month and 12 month
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 19 Aug 2026.
- Individual participant dataSharing planned: Yes. only IPD used in the results publication
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VPT /pulpotomy, VPT/complete pulpotomy and vital pulp therapy /complete pulpotomy in people with Post-operative Pain and Vital Pulp Therapy, run by Abdelrahman Refaat Khalaf Ahmed at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: enrolling by invitation, as of the sponsor's last update on 19 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 Egypt. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post operative pain (time frame: Pain will be recorded preoperative and after 6 hours, 12 hours , 24 hours , 72 hours and 1 week using numerical rate scale (NRS)). 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 19 Aug 2026; AzTrials last refreshed its copy on 7 Nov 2026.