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NCT Number: NCT07771816

Impact of Sodium Hypochlorite Irrigation at Different Concentrations, With and Without Cryotherapy, on Post Operative Pain in Permanent Mandibular Molar Teeth.

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?

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Vital Pulp Therapies

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 in Egypt

Cairo, Cairo Governorate, 11835, Egypt

About this study

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

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

vital pulp therapy

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. 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.

Secondary outcomes

  1. overall success

    Time frame: 3 months, 6 months and 12 months after treatment

    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.

Sponsors and collaborators

Lead sponsor

Future University in Egypt

Other

Registry information

Official study 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"

Acronym: VPT-RCT-MTA

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 18, 2026
Registry last updated
Aug 18, 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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