Postoperative PainVPT-RCT-MTANCT07771816
Impact of Sodium Hypochlorite Irrigation at Different Concentrations, With and Without Cryotherapy, on Post Operative Pain in Permanent Mandibular Molar Teeth.
A study testing vital pulp therapy in people with Postoperative Pain and Vital Pulp Therapies, run by Future University in Egypt at 1 site in Egypt.
Trial summary
The aim of the present study will compare the impact of sodium hypochlorite irrigation at different concentrations with and without cryotherapy on post operative pain in permanent mandibular molar teeth. Read more about this study
- Who is it for?
- Ages 15 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain, Vital Pulp Therapies
- What is being tested?
- vital pulp therapy
- 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 Sep 2026to 1 Mar 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 in Egypt
Cairo, Cairo Governorate, 11835
About this study
Official title: Impact of Sodium Hypochlorite Irrigation at Different Concentrations, With and Without Cryotherapy, on Post Operative Pain in Permanent Mandibular Molar Teeth "Randomized Controlled Trial"
The aim of the present study will compare the impact of sodium hypochlorite irrigation at different concentrations with and without cryotherapy on post operative pain in permanent mandibular molar teeth.
Will cryotherapy combined with sodium hypochlorite irrigation at different concentrations reduce postoperative pain in compared to conventional sodium hypochlorite irrigation during pulpotomy of mandibular molar teeth with symptomatic irreversible pulpitis?
Read the detailed description
Sodium hypochlorite (NaOCl) is among the most commonly recommended irrigants due to its broad-spectrum antimicrobial effect, ability to dissolve organic tissue, and efficacy in eliminating biofilm(6). However, most of the evidence supporting its use comes from studies in root canal therapy, not vital pulp therapy. NaOCl action in pulpotomy differs significantly because the material comes into direct contact with living, vascularized, sensitive pulp tissue, raising concerns about its potential cytotoxicity
- Conditions
- Postoperative Pain, Vital Pulp Therapies
- Being tested
- vital pulp therapy
- Keywords
- cryotherapy, pulpotomy
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vital pulp therapyProcedure 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 therapyProcedure 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 therapyProcedure 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 |
|---|---|---|
| 1.5% NaOCl irrigation at room temperature. | Experimental | vital pulp therapy with 1.5% NaOCl irrigation at room temperature. Receives: Procedure: vital pulp therapy |
| cryo treated 1.5% NaOCl irrigation. | Experimental | Vital pulp therapy with cryo treated 1.5% NaOCl irrigation. Receives: Procedure: vital pulp therapy |
| cryo treated 2.5% NaOCl irrigation. | Experimental | Vital pulp therapy with cryo treated 2.5% NaOCl irrigation. Receives: Procedure: vital pulp therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain
numerical rate scale (NRS), ranging from 0 (no pain) to 10 (worst pain), with higher scores indicating greater pain.
Measured: Pain will be assessed at baseline (preoperatively) and postoperatively at 6 hours, 12 hours , 24 hours , 72 hours and 1week after treatment.
Secondary outcomes (1)
overall success
Overall treatment success assessed by clinical examination and digital periapical radiographs. Clinical success is defined as absence of spontaneous pain, tenderness to percussion, swelling, sinus tract, or other clinical signs of failure, with no new periapical pathology on radiographic examination.
Measured: 3 months, 6 months and 12 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative 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
- Future University in Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Mohamed Elsayed Aboelazm, Future University in Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07771816
- Sponsor's protocol ID
- FUE.REC(5)/1-2026
- Acronym
- VPT-RCT-MTA
- Status last verified
- Dec 2025
- First submitted
- 12 Aug 2026
- Last updated
- 18 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 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Sodium Hypochlorite Irrigation at Different Concentrations, With and Without Cryotherapy, on Post Operative Pain in Permanent Mandibular Molar Teeth "Randomized Controlled Trial"
- ClinicalTrials.gov ID
- NCT07771816
- Acronym / sponsor ID
- VPT-RCT-MTA / FUE.REC(5)/1-2026
- Conditions
- Postoperative Pain, Vital Pulp Therapies
- Keywords
- cryotherapy, pulpotomy
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 3 participants (estimated)
- Lead sponsor
- Future University in EgyptUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 18 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 irrigation at different concentrations with and without cryotherapy on post operative pain in permanent mandibular molar teeth.
Will cryotherapy combined with sodium hypochlorite irrigation at different concentrations reduce postoperative pain in compared to conventional sodium hypochlorite irrigation during pulpotomy of mandibular molar teeth with symptomatic irreversible pulpitis?
Detailed description
Sodium hypochlorite (NaOCl) is among the most commonly recommended irrigants due to its broad-spectrum antimicrobial effect, ability to dissolve organic tissue, and efficacy in eliminating biofilm(6). However, most of the evidence supporting its use comes from studies in root canal therapy, not vital pulp therapy. NaOCl action in pulpotomy differs significantly because the material comes into direct contact with living, vascularized, sensitive pulp tissue, raising concerns about its potential cytotoxicity
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1.5% NaOCl irrigation at room temperature. | Experimental | Procedure: vital pulp therapyvital pulp therapy with 1.5% NaOCl irrigation at room temperature. |
| cryo treated 1.5% NaOCl irrigation. | Experimental | Procedure: vital pulp therapyVital pulp therapy with cryo treated 1.5% NaOCl irrigation. |
| cryo treated 2.5% NaOCl irrigation. | Experimental | Procedure: vital pulp therapyVital pulp therapy with cryo treated 2.5% NaOCl irrigation. |
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 |
|---|---|---|
| vital pulp therapyEndodontic 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 | 1.5% NaOCl irrigation at room temperature. |
| vital pulp therapyEndodontic 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 | cryo treated 1.5% NaOCl irrigation. |
| vital pulp therapyEndodontic 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 | cryo treated 2.5% NaOCl irrigation. |
Primary outcome
postoperative pain
Time frame: Pain will be assessed at baseline (preoperatively) and postoperatively at 6 hours, 12 hours , 24 hours , 72 hours and 1week after treatment.
numerical rate scale (NRS), ranging from 0 (no pain) to 10 (worst pain), with higher scores indicating greater pain.
1 secondary outcome
overall success
Time frame: 3 months, 6 months and 12 months after treatment
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 18 Aug 2026.
- Individual participant dataSharing planned: Yes. only IPD used in the results publication
Related trials for Postoperative Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
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 vital pulp therapy in people with Postoperative Pain and Vital Pulp Therapies, run by Future University in Egypt 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 18 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?
postoperative pain (time frame: Pain will be assessed at baseline (preoperatively) and postoperatively at 6 hours, 12 hours , 24 hours , 72 hours and 1week after treatment.). 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 18 Aug 2026.