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NCT Number: NCT07764666

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 ?

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Key information

Conditions

Post-operative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Vital Pulp Therapy

Age range

15 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Oral and Dental Medicine future university, Cairo,

Cairo, Cairo Governorate, 11835, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

VPT /pulpotomy

Procedure

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

Procedure

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

Procedure

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Clinical and Digital radiograph overall success

    Time frame: 3 month ,6 month and 12 month

    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

Sponsors and collaborators

Lead sponsor

Abdelrahman Refaat Khalaf Ahmed

Other

Registry information

Acronym: NaOCl/VPT/MTA

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 14, 2026
Registry last updated
Aug 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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