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Enrolling by invitation Not applicable

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.

NCT07764666 · tracked via the Priya Life Science Egypt tracker
Sponsor
Abdelrahman Refaat Khalaf Ahmed
Phase
Not applicable
Started
2026-01-01
Last updated
2026-08-19

Condition(s) studied

Post-operative PainVital Pulp Therapy

Investigational drug(s) / intervention(s)

VPT /pulpotomyVPT/complete pulpotomyvital pulp therapy /complete pulpotomy

VPT /pulpotomy: 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 pulpotomy: 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 pulpotomy: 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 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 an effect on post-operative pain and overall success following pulpotomy in permanent mandibular molar compared to normal saline irrigation ?

Eligibility

Sex
ALL
Min age
15 Years
Max age
40 Years
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

  • post operative pain — 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.

Trial sites (1)

FacilityCityRegionStatus
Faculty of Oral and Dental Medicine future university, Cairo, Cairo Cairo Governorate
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07764666 on ClinicalTrials.gov ↗ ← All trials in Egypt